[Federal Register Volume 64, Number 229 (Tuesday, November 30, 1999)]
[Proposed Rules]
[Pages 66822-66828]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-30957]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 10
[Docket No. 99N-2497]
Citizen Petitions; Actions That Can be Requested by Petition;
Denials, Withdrawals, and Referrals for Other Administrative Action
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
its regulations pertaining to citizen petitions. The proposal would
cover citizen petition requests to issue, amend, or revoke a
regulation; requests to amend or revoke an order that FDA has issued or
published; or any other action specifically authorized by another FDA
regulation. The document further clarifies that persons who wish to
contact the agency on matters outside these three types of actions
would still be able to do so through informal means, such as letters
and telephone calls. In addition the proposal would also revise certain
content requirements for citizen petitions and would permit FDA to
refer petitions for other administrative action, seek clarification of
a petitioner's requests, withdraw certain petitions, and combine
petitions. These changes are intended to improve the citizen petition
mechanism.
DATES: Submit written comments by February 28, 2000. Submit written
comments on the information collection provisions by December 30, 1999.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. Submit written comments on the information
collection provisions to the Office of Information and Regulatory
Affairs, OMB, New Executive Office Bldg., 725 17th St. NW., Washington,
DC 20503, ATTN: Wendy Taylor, Desk Officer for FDA
FOR FURTHER INFORMATION CONTACT: Philip L. Chao, Office of Policy (HF-
23), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD
20857, 301-827-3380.
SUPPLEMENTARY INFORMATION:
I. Introduction
There are several mechanisms which can be used to contact FDA on a
particular matter or issue. These mechanisms can be informal, such as
calling the agency, sending a fax or electronic mail, writing a letter
(see Sec. 10.65(a) (21 CFR 10.65(a))), or requesting a meeting (see,
e.g., Sec. 10.65(b) and (c)). They may also be more formal, such as
requesting a public hearing (see, e.g., 21 CFR 12.20) or submitting a
citizen petition (see Sec. 10.30 (21 CFR 10.30)).
Many persons use citizen petitions under Sec. 10.30 to contact FDA
on a diverse range of issues. The issues can be very specific, such as
detailed scientific concerns about a particular product's safety or
bioequivalence, but occasionally pertain to matters outside FDA's
jurisdiction or to matters that would require legislative, rather than
regulatory, relief. This results in a large number of citizen petitions
filed at FDA. As of April 1999, several hundred citizen petitions have
been filed and remain pending.
In many instances, it is readily apparent that citizen petitions
may not be the best or most efficient mechanism for addressing the
underlying subject or issue. For example, FDA often receives petitions
requesting prompt or immediate action, yet each petition, after being
filed and assigned to the appropriate office or center, must compete
against other agency priorities, including other citizen petitions
filed earlier. In contrast, a telephone call, letter, or a request for
a meeting, while lacking the formal processing associated with citizen
petitions, is usually an easier, faster, and more efficient way to
discuss the same issue with the agency.
Reviewing and responding to these petitions can also be, and often
is, a resource-intensive and time-consuming task because FDA must
research the petition's subject, examine scientific, medical, legal,
and sometimes economic issues, and coordinate internal agency review
and clearance of the petition response. In many instances, FDA must
issue a tentative response stating that the agency is unable to reach a
decision on the petition within the 180-day response period established
in FDA's regulations.
Questions have also arisen whether a citizen petition can be used
for improper purposes, such as delaying competition (see, e.g., Noah,
L., ``Sham Petitioning as a Threat to the Integrity of the Regulatory
Process,'' 74 N. Carolina L. Rev. 1 (1995) (also noting that the
Federal Trade Commission, in 1993, had concerns that petitions were
being submitted to FDA for anticompetitive reasons)) or delaying agency
action. Some petitioners have submitted multiple citizen petitions
concerning the same subject or product
[[Page 66823]]
with each petition containing one or few requests, while others have
submitted several citizen petitions on the same subject or product over
an extended time period. These petitions drain FDA resources both
repeatedly and inefficiently because they commit FDA to multiple
reviews and responses rather than having FDA consider and respond to
all issues at one time.
Recently, the Office of the Inspector General (OIG) in the
Department of Health and Human Services reviewed FDA's citizen
petitions process to assess the agency's effectiveness in handling
citizen petitions and to identify ways that the process can be
improved. The OIG noted that FDA had examined various options for
reducing the citizen petition backlog and suggested that those options
be thoroughly discussed within the agency and ``implemented where
practical.''
This proposed rule contains several of those options and is
intended to facilitate and to improve interactions between FDA and
interested persons. The proposed rule would clarify the types of
requests that may be the subject of a citizen petition and increase
FDA's flexibility in responding to or taking action in response to a
citizen petition.
FDA emphasizes that the proposed rule is not intended to and does
not reduce or curtail access to or discussions with the agency. For
example, FDA's regulations provide for meetings and correspondence
(see, e.g., Sec. 10.65), and other FDA regulations provide for meetings
under certain situations (see, e.g., 21 CFR 314.102 (communication
between FDA and persons who have submitted new drug application or
abbreviated new drug application (ANDA))). Informal avenues of
communication, such as telephone calls, faxes, and electronic mail,
also exist. These avenues of communication can be faster and more
efficient methods for discussing issues or addressing concerns than
citizen petitions.
In addition to this rule, FDA has taken, or is exploring, various
administrative approaches to reduce its citizen petition backlog and
improve its handling of citizen petitions. These actions have included
contacting petitioners whose requests are of long standing to determine
whether they still want FDA to take action on their petitions and
revising delegations of authority so that certain FDA centers may issue
a greater range of petition responses. FDA is also considering options
for improving managerial and oversight responsibility for citizen
petitions to ensure that the citizen petition process is efficient and
effective.
II. Description of the Proposed Rule
Under FDA's existing regulations, any person may submit a citizen
petition to the agency requesting that the Commissioner of Food and
Drugs (the Commissioner): (1) Issue, amend, or revoke a regulation; (2)
issue, amend, or revoke an order; or (3) take or refrain from taking
any other form of administrative action (Sec. 10.30(a) and (b)). The
regulations also direct the agency to issue a response to a citizen
petition within 180 days after receiving a petition (Sec. 10.30(e)(2)).
(For petitions requesting permission to submit an ANDA for certain
drugs, the response period is 90 days (see Sec. 10.30(e)(4)).) The
response can either approve the petition, deny the petition, or provide
a tentative response, indicating why the agency has been unable to
reach a decision on the petition (Sec. 10.30(e)(2)).
A. Proposed Sec. 10.30(b)
1. Actions That May be Requested in a Citizen Petition
The proposed rule would amend the citizen petition requirements at
Sec. 10.30(b) and its description of the actions that may be requested
in a citizen petition. Under the proposal, a citizen petition could
request that the agency: (1) Issue, amend, or revoke a regulation; (2)
amend or revoke an order that the agency has issued or published; or
(3) take an action as specifically authorized by another FDA
regulation.
The proposal would not alter a person's ability to petition the
agency for the issuance, amendment, or revocation of a regulation. The
Administrative Procedure Act (5 U.S.C. 553(e)) expressly provides for
such petitions, and the proposal would preserve a person's ability to
petition for rulemaking.
The proposal would, however, require that the requested regulation
pertain to a subject that is appropriately and ordinarily addressed by
regulation rather than other administrative action. For example, a
petition that sought to amend the format and content requirements for
an ANDA may be within the proposed rule because the requested change
would be applicable to all ANDA's. However, a petition that sought a
regulation directly or indirectly prohibiting the approval of a
particular generic drug product, declaring a particular generic product
to be unsafe, ineffective, or not bioequivalent, or prohibiting a class
of generic drug products would, in most cases, not fall within the
proposed rule because FDA generally does not issue regulations to
prohibit the approval of individual generic drug products.
FDA considered, but did not include in this proposed rule, a
requirement that petitioners show why the requested rulemaking or
action is within FDA's legal authority. The existing regulations
require a petitioner to provide the factual and legal grounds on which
the petitioner relies, but despite this requirement, the agency
sometimes receives petitions requesting actions that are beyond FDA's
legal authority or actions that are a matter of State law. For example,
a petition requesting that FDA, under its existing statutory authority
for drug products, regulate a particular class of drugs products would
be appropriate, whereas a petition requesting that FDA require firms to
observe certain employment practices (a matter that is generally not
within FDA's legal authority) would not. Consequently, the agency
contemplated various ways to have would-be petitioners request only
those actions that fall under FDA's authority, but without requiring
petitioners to provide a detailed or exhaustive legal analysis or to
retain legal services to draft arguments on FDA's legal authority. The
agency invites comments on how a rule might ask petitioners to ensure
that their requested actions are within FDA's legal authority without
making those petitioners do a detailed or exhaustive legal analysis.
For citizen petitions concerning agency orders, the proposal would
amend Sec. 10.30(b) to limit citizen petitions to requests that FDA
amend or revoke an order that FDA has issued. In other words, a citizen
petition could not be used to request that FDA amend pending FDA orders
or issue future FDA orders. This change will enable FDA to focus its
resources on addressing substantive issues or controversies, rather
than devote resources to speculating about future orders or to
addressing subjects which may not be an agency priority or present any
significant public health issues.
The proposal would also require the citizen petition to be based
on more than unsupported claims, allegations, or general descriptions
of positions or arguments. Although the existing regulation requires
petitioners to provide a full statement of the factual grounds on which
the petitioner relies, some petitions contain little or no evidence or
support or rely on obsolete, irrelevant, or erroneous information.
Thus, the proposal would deter the submission of frivolous or
unsupported petitions and petitions which simply disagree with an
agency decision regardless of the scientific evidence or legal
authority supporting that decision, the importance of the public health
[[Page 66824]]
policies supporting that decision, or the petitioner's lack of sound
scientific evidence or legal authority to support its request.
FDA is aware that the proposed change would remove a person's
ability to petition FDA to issue an order or to affect a pending order
and that some may object to this proposed change on the ground that
persons should be able to present arguments and evidence to FDA before
it makes a decision. Again, the agency emphasizes that the proposal
does not prevent a person from contacting FDA nor does it curtail
access to the agency. Persons who desire to present information to FDA
would be able to do so through letters, electronic mail, meetings,
discussions, and other avenues of communication. If FDA receives
important information before it makes a decision, it will make
appropriate use of that information. For example, if a person submitted
information to FDA to argue that a particular test should be conducted
before FDA approves a specific product, the agency may consider that
information during its review of the product's application and consult
the applicant and others on the issue. The fact that the information
may not have been submitted in a citizen petition does not make the
information any less persuasive or mean that it will receive less
attention from FDA. In short, the citizen petition mechanism is not the
sole mechanism for contacting FDA, especially with respect to persons
who wish to provide information to FDA before the agency decides on or
takes a specific course of action.
The proposal would also change the third category of citizen
petitions -- petitions requesting that the Commissioner ``take or
refrain from taking any other form of administrative action''-to
petitions requesting that the Commissioner take an action ``as
specifically provided by regulation'' and would require the petitioner
to cite the regulation at issue. The reference to actions
``specifically provided by regulation'' is intended to reflect over 20
FDA regulations which expressly provide for or instruct interested
persons to submit citizen petitions in order to achieve a particular
result. For example, under 21 CFR 60.30(b), a person may file a citizen
petition if that person wishes to challenge the regulatory review
period determination for a particular product which is being considered
for patent term extension. FDA's regulations permit persons to submit a
citizen petition if they seek an exemption from the pregnancy nursing
warning (21 CFR 201.63(d)). Under 21 CFR 861.38(b)(2), an interested
person may petition to establish, amend, or revoke a performance
standard. The proposed rule would continue to allow petitions under
these and other FDA regulations that expressly refer to the citizen
petitions process, but the proposal would no longer provide an
unqualified ability to use the citizen petition process for ``any other
form of administrative action.''
FDA reiterates that persons who wish to contact FDA on matters
outside the three types of actions described in proposed Sec. 10.30(b)
would still be able to do so through other means, such as
correspondence, electronic mail, telephone calls, etc., and FDA will
respond to such correspondence and other communications promptly. The
agency is simply reorganizing its citizen petition mechanism to make it
more focused and responsive.
2. Certification Statement for Citizen Petitions
Currently, Sec. 10.30(b) requires a petitioner to certify, to its
best knowledge and belief, that the petition includes all information
and views on which the petitioner relies and includes ``representative
data and information known to the petitioner which are unfavorable to
the petition.'' To complement the other proposed changes to
Sec. 10.30(b), FDA is proposing to revise the certification statement.
The proposed revision would have petitioners certify that, to the
petitioner's best knowledge and belief, its citizen petition ``includes
all information and views on which the petition relies, that it is well
grounded in fact and is warranted by existing laws or regulations, that
it is not submitted for any improper purpose, such as to harass or to
cause unnecessary delay, and that it includes representative data and
information known to the petitioner which are unfavorable to the
petition.''
B. Proposed Sec. 10.30(e)(2)(ii)--Denial of Citizen Petitions
To facilitate responses to citizen petitions and to promote more
efficient use of agency resources, the proposed rule would amend
Sec. 10.30(e)(2)(ii) to state that FDA's denial of a citizen petition
may be ``brief, as appropriate.'' This is intended to conserve FDA's
resources by eliminating the need to conduct exhaustive or
comprehensive analyses and responses to requests or issues that the
agency has already decided earlier in a different administrative
proceeding or action and to give FDA the flexibility to act quickly on
petitions where detailed responses are unnecessary. For example, under
the proposal, if the citizen petition asked the agency to amend a
regulation in a particular way, and FDA considered and rejected the
same comment or a similar comment when the agency was drafting the
final regulation, and the citizen petition contained no new evidence
warranting a change in FDA's earlier decision, the agency's denial
letter might simply state that the agency considered the same matter
during the rulemaking and that the petition did not provide any new
information that would change FDA's earlier decision.
Other examples of where a brief response denying a petitioner's
request may be appropriate include, but are not limited to:
1. A citizen petition that makes a request that is outside FDA's
legal authority or is based on unsupported claims or allegations. This
would complement the changes in proposed Sec. 10.30(b).
2. A citizen petition that is substantially similar or identical,
in terms of its requests or issues, to an earlier administrative
proceeding or action, and the citizen petition has not identified any
significant change in evidence, laws, or regulations that affect the
previous administrative proceeding or action. For example, in the past,
some petitioners have submitted the same or similar petitions after
receiving an unfavorable response. In these situations, when there has
been no change in evidence, laws, or regulations since FDA's earlier
response, the agency's denial letter might simply say that the agency
has previously considered the same or similar request and that the
petition has provided no new information that would change the agency's
earlier decision.
3. A citizen petition where the agency has determined that the
petition does not implicate a significant public health issue, and the
agency lacks the resources to provide a more detailed response or to
take the action requested by the petitioner. This may occur, for
example, where the petitioner requests a change in FDA's regulations
that has no significant public health implications, such as amending or
establishing common or usual names regulations or standards of
identity, quantity, and fill of container regulations for foods or
allowing the use of a different test or method or a different
manufacturing standard when the difference has no significant public
health advantage over the existing test, method, or standard. In the
absence of a significant public health issue, and considering the
intense demand on FDA's resources, the agency must allocate its
resources carefully and
[[Page 66825]]
wisely, so brief denial of these types of citizen petitions would be
appropriate.
4. A citizen petition where changes in fact, science, or law since
the date on which the citizen petition was submitted have made the
petition moot. For example, if a citizen petition requested a change to
a regulation that has been rescinded or withdrawn, drafting a detailed
response to the petitioner's requested change would not be an efficient
use of agency resources. Thus, a brief denial for these petitions would
be appropriate.
C. Proposed Sec. 10.30(e)(4)--Referral and Withdrawal of Citizen
Petitions and Consolidation of Multiple Petitions
Proposed Sec. 10.30(e)(4)(i) would authorize FDA to take
administrative action other than preparing a formal response to a
citizen petition. This would occur when a citizen petition involves a
subject that is being addressed in another administrative proceeding
(such as an ongoing or future rulemaking) or presents issues or
involves requests that can be addressed through correspondence,
meetings, or other agency action. Under such circumstances, the
proposed rule would permit, but not require, the agency to refer the
petitioner's information to the other administrative proceeding or to
refer the petitioner's information to the relevant FDA center for its
consideration and any appropriate action. If FDA refers a citizen
petition to another administrative proceeding, the citizen petition
would remain filed in FDA's Dockets Management Branch, but the agency
would place a note in the citizen petition's docket stating that the
petitioner's information has been referred to another administrative
proceeding and that the petition's docket is closed.
For example, FDA sometimes receives petitions on topics that are
the subject of a pending FDA regulation. Under the proposed rule, FDA
could refer the petition to the docket for the rulemaking where it
would be treated as if it were a comment on the rule, and the
petition's docket would contain a note referring to the rulemaking.
Referring information to the appropriate administrative proceeding
would be an efficient and practical mechanism for reviewing scientific
or technical issues because it would ensure that the relevant FDA
office considers the petitioner's information in conjunction with the
data and information contained in the administrative proceeding (as
opposed to allocating separate resources to the administrative
proceeding and to the citizen petition or completing the administrative
proceeding and citizen petition at different times).
As another example, some petitions raise substantive scientific
issues and request that the agency not approve or rescind approval of a
specific product. In these cases, it may be more appropriate for the
agency to investigate the scientific issues or conduct a meeting to
discuss those issues before deciding what regulatory action, if any, to
take against the product. Thus, the proposed rule would preserve FDA's
flexibility to develop the appropriate administrative response. This
flexibility may be particularly valuable when, after reviewing the
petitioner's request, the agency determines that the best solution is
different from the one suggested by the petitioner.
Proposed Sec. 10.30(e)(4)(ii) would permit the agency to seek
clarification of a petitioner's requests. Occasionally, FDA receives
citizen petitions that make vague or conflicting requests, but the
existing regulations do not expressly permit FDA to request
clarification from the petitioner. The proposal would remedy this by
permitting FDA to seek clarification. The request for clarification
would include a time period for providing the clarifying information to
FDA. If the petitioner fails to provide the requested clarification to
FDA within that time period, proposed Sec. 10.30(e)(4)(ii) would permit
the agency to consider the petition to be withdrawn.
Proposed Sec. 10.30(e)(4)(iii) would permit FDA to consider a
citizen petition to be withdrawn where the agency is aware that the
petitioner no longer exists or the petitioner cannot be located, or
where the petitioner has expressly stated that it does not seek a
response to its petition. For example, if a firm submitted a citizen
petition and subsequently went out of business, the proposal would
permit FDA to consider the petition to be withdrawn. As another
example, in rare cases, persons have submitted citizen petitions to
protest a particular FDA action. These petitions state that they are
submitted as a protest or for symbolic reasons and that no response is
sought or expected. Nevertheless, existing regulations do not give FDA
express authority to withdraw these petitions even though it is both
illogical and a waste of agency resources to require FDA to develop and
to issue petition responses when the petitioner no longer exists or
when the petitioner seeks no response. The agency does not contemplate
using this authority often.
Proposed Sec. 10.30(e)(4)(iv) would apply where FDA has received
multiple citizen petitions on the same subject or involving the same
product or has received similar or identical citizen petitions from
different parties. These citizen petitions, which sometimes contain
only a single request and are submitted over an extended period of
time, divert FDA resources repeatedly and, from FDA's perspective,
inefficiently when the petitioner or petitioners could have easily
submitted all requests in the same petition or when the petitioner
submits essentially the same petition repeatedly. The proposal,
therefore, would enable FDA to combine multiple citizen petitions on
the same issue or product. The agency encourages potential petitioners
to combine petitions and requests to the greatest extent practicable.
D. Conforming or Miscellaneous Amendments
Section 10.25(a) (21 CFR 10.25(a)) currently states how petitions
can be used to initiate an administrative proceeding. Because proposed
Sec. 10.30 would redefine the types of actions that may be the subject
of a citizen petition, the agency is proposing to revise Sec. 10.25(a)
to enable interested persons to request (rather than ``petition'' for)
the initiation of an administrative proceeding. Such requests would be
made when the desired administrative proceeding falls outside the scope
of proposed Sec. 10.30.
Because the proposed rule would permit the agency to refer and to
withdraw citizen petitions under certain conditions, two conforming
amendments to Sec. 10.30(e)(1) and (e)(2) would be necessary.
Currently, Sec. 10.30(e)(1) states that the Commissioner shall ``rule
upon'' each petition. Arguably, because a decision to withdraw a
citizen petition does not necessarily involve a decision directly on
the citizen petition's merits, FDA is proposing to amend
Sec. 10.30(e)(1) to state that the Commissioner shall ``act upon'' each
citizen petition.
Similarly, Sec. 10.30(e)(2) states that the Commissioner shall
furnish a response to each petitioner within 180 days (except to
persons who submitted suitability petitions, in which case the response
time period is 90 days). Arguably, a decision to refer or withdraw a
citizen petition under the proposed rule might not be considered a
``response,'' so FDA is proposing to amend Sec. 10.30(e)(2) to state
that, ``Except as provided in paragraphs (e)(4) and (e)(5) of this
section * * *.''
The proposal would also revise Sec. 10.30(b) to update the address
for the Dockets Management Branch.
[[Page 66826]]
III. Legal Authority
When first issued over 20 years ago, FDA's citizen petition
regulations were intended to reflect the right to petition the
government and to reduce ``confusion and uncertainty on the part of
those who wish to petition the agency on a particular matter, as well
as on the part of those in the agency who have received various forms
of requests and have been unable to determine how they should be
handled'' (see 40 FR 40682 at 40686, September 3, 1975).
The right to petition, however, is not absolute; it does not
include the right to speak to government officials (see Welch v. Board
of Education of Baltimore County, 477 F. Supp. 959 (D. Md. 1979)), nor
does it include the right to an oral hearing (see Stengel v. City of
Columbus, Ohio, 737 F. Supp. 1457 (S.D. Ohio 1988)). Neither does the
right to petition the government create an affirmative duty on the
government to act or to investigate. See Minnesota State Board for
Community Colleges v. Knight, 104 S. Ct. 1058, 1067 (1984); Smith v.
Arkansas State Highway Employees, 441 U.S. 463, 465 (1979); Gordon v.
Heimann, 514 F. Supp. 659 (N.D. Ga. 1980); Town of Brookline v.
Goldstein, 447 N.E.2d 641, 646 (Mass. 1983).
In fact, court opinions indicate that agencies have broad
discretion in establishing and applying rules for public participation
in agency matters (see Cities of Statesville, et al. v. Atomic Energy
Commission, 441 F. 2d 962 (D.C. Cir. 1969); Pasco Terminals, Inc. v.
United States, 477 F. Supp. 201 (1979), aff'd 634 F. 2d 610)).
Moreover, the Supreme Court has indicated that courts cannot require
more than minimum procedural boundaries even if a proposed regulation
would establish complex or technical factual issues or important public
issues; in those instances, an agency is to decide whether additional
procedures are needed. See Vermont Yankee Nuclear Power Corp. v.
Natural Resources Defense Council, Inc., 98 S. Ct. 1197, 1202 (1978).
Here, the proposed rule does not restrict access to or contact with
the agency; it simply redefines the types of actions that may be the
subject of ``citizen petitions'' under Sec. 10.30 in order to make that
formal administrative mechanism more responsive and efficient. Indeed,
given that other FDA's regulations provide other means for contacting
the agency (see, e.g., Sec. 10.65(a) (regarding correspondence)), the
citizen petition regulation at Sec. 10.30 cannot and should not be
viewed as being the sole or exclusive mechanism for ``petitioning'' FDA
or as an exclusive mechanism for exercising a right to petition FDA.
Certain aspects of the proposed rule, such as the proposed
provisions concerning brief denials, withdrawals, and referrals to
other administrative action, would affect how citizen petitions are
handled. However, as stated earlier, agencies have broad discretion in
establishing and applying rules for public participation in
administrative matters. The proposal furthers an important government
interest-permitting the agency to concentrate its resources on agency
priorities and statutory obligations instead of diverting those
resources to, for example, citizen petitions that request actions
outside FDA's authority, that repeat requests that the agency has
already addressed, or that are submitted for symbolic purposes.
Furthermore, as court decisions readily indicate, the right to
petition does not impose any duty on the government to take any
specific action. Given this case precedent, it would be illogical to
conclude that the right to petition demands that FDA continue to
receive citizen petitions under Sec. 10.30 requesting actions which FDA
cannot legally perform or to have FDA decide how it might act on a
particular issue in the future. The proposed rule preserves an
individual's ability to submit a citizen petition to FDA for actions
that FDA has taken and for actions that are within FDA's legal
authority, as well as other types of actions specified in proposed
Sec. 10.30.
Persons who wish to contact or ``petition'' FDA on issues that are
outside the scope of proposed Sec. 10.30 would still be able to contact
the agency, through letters, calls, or other means of communication.
FDA emphasizes, again, that the proposed rule would not reduce public
access to FDA; instead, it is intended to make the formal citizen
petition process more efficient and more responsive.
IV. Environmental Impact
The agency has determined under 21 CFR 25.30(a) and (h) that this
action is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
V. Analysis of Impacts
FDA has examined the impacts of this proposed rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612) and
the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive
Order 12866 directs agencies to assess all costs and benefits of
available regulatory alternatives and, when regulation is necessary, to
select regulatory approaches that maximize new benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). Under the Regulatory
Flexibility Act, unless an agency certifies that a rule will not have a
significant impact on a substantial number of small entities, the
agency must analyze regulatory options that would minimize the impact
of the rule on small entities.
The Unfunded Mandates Reform Act of 1995 requires that agencies
prepare an assessment of anticipated costs and benefits before
proposing any rule that may result in an expenditure in any one year by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100 million or more (adjusted annually for
inflation).
The agency has reviewed this proposed rule and determined that it
is consistent with the regulatory philosophy and the principles
identified in the Executive Order 12866 and these two statutes. Though
this proposed rule is not economically significant, it has been
determined by OMB that this proposed rule is a significant regulatory
action.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant economic impact
on small entities. The proposed rule would define the actions that may
be the subject of a citizen petition and facilitate efficient
resolution of citizen petitions. It would not preclude persons from
using less formal means (such as letters) to contact the agency. In
fact, because less formal means of communication lack the format and
procedures associated with citizen petitions, the economic impact on
small businesses should be reduced when compared against the existing
citizen petition mechanism. Thus, the agency certifies that this rule
will not have a significant economic impact on a substantial number of
small entities. Therefore, under the Regulatory Flexibility Act, no
further analysis is required.
VI. Paperwork Reduction Act of 1995
This rule contains information collection requirements that are
subject to public comment and review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). A description of these provisions is given
[[Page 66827]]
below in this section of the document with an estimate of the annual
reporting and recordkeeping burden. Included in the estimate is the
time for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and reviewing
each collection of information.
FDA invites comments on: (1) Whether the collection of information
is necessary for the proper performance of FDA's functions, including
whether the information will have practical utility; (2) the accuracy
of FDA's estimate of the burden of the collection of information,
including the validity of the methodology and assumptions used; (3)
ways to enhance the quality, utility, and clarity of the information to
be collected; and (4) ways to minimize the burden of the collection of
information on respondents, including through the use of automated
collection techniques, when appropriate, and other forms of information
technology.
Title: Citizen Petitions; Actions That Can be Requested by
Petition; Denials, Withdrawals, and Referrals for Other Administrative
Action
Description: The proposed rule would specify the types of actions
that could be requested through a citizen petition. The proposal would
also revise the content requirements for citizen petitions and provide
authority for the agency to refer petitions for other administrative
action, seek clarification of a petitioner's requests, withdraw certain
petitions, and combine petitions.
Description of Respondents: Businesses, trade organizations, public
interest groups, and individuals.
The proposed rule would increase the estimated burden associated
with the information collection requirements from 1,440 hours to 2,646
hours. FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
Annual
21 CFR Section No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
----------------------------------------------------------------------------------------------------------------
10.30 189 1 189 14 2,646
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
The estimates in Table 1 reflect the reporting burden that would be
attributable solely to the rule. FDA derived these estimates by
examining its records to determine the average number of citizen
petitions submitted to FDA and by decreasing the number of respondents
by 30 percent. The agency calculated the percentage reduction in
citizen petitions by reviewing all citizen petitions filed in a 6-month
period in 1997 against the proposed rule's citizen petition criteria.
The review suggested that the proposed rule would reduce the number of
citizen petitions by over 30 percent, but the agency is adopting the 30
percent estimate as an initial estimate.
Additionally, FDA has revised the hours per response from 12 hours
to 14 hours. The additional two hours reflect the proposed rule's
changes to the content requirements for a citizen petition and the
change to the certification statement. This additional amount of time
may be overestimated because, under the existing citizen petition
regulation, petitioners are already required to provide all relevant
information and views and a certification as part of their petitions.
The agency has submitted the information collection requirements of
this rule to OMB for review. Interested persons are requested to send
comments regarding information collection by December 30, 1999, to the
Office of Information and Regulatory Affairs, OMB (address above).
Interested persons may, on or before February 28, 2000, submit to
the Dockets Management Branch (address above) written comments
regarding this proposal. Two copies of any comments are to be
submitted, except that individuals may submit one copy. Comments are to
be identified with the docket number found in brackets in the heading
of this document. Received comments may be seen in the office above
between 9 a.m. and 4 p.m., Monday through Friday.
List of Subjects in 21 CFR Part 10
Administrative practice and procedure, News media.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR part 10 be amended as follows:
PART 10--ADMINISTRATIVE PRACTICES AND PROCEDURES
1. The authority citation for 21 CFR part 10 continues to read as
follows:
Authority: 5 U.S.C. 551-558; 701-706; 15 U.S.C. 1451-1461; 21
U.S.C. 141-149, 321-397, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42
U.S.C. 201, 262, 236b, 264.
2. Section 10.25 is amended by revising paragraph (a) to read as
follows:
Sec. 10.25 Initiation of administrative proceedings.
* * * * *
(a) An interested person may petition the Commissioner to issue,
amend, or revoke a regulation or order, or request that the
Commissioner take or refrain from taking any other form of
administrative action. For petitions involving a regulation or order,
the petition must be either:
(1) In the form specified in other applicable FDA regulations,
e.g., the form for a color additive petition in Sec. 71.1 of this
chapter, for a food additive petition in Sec. 171.1 of this chapter,
for a new drug application in Sec. 314.50 of this chapter, for a new
animal drug application in Sec. 514.1 of this chapter, or
(2) In the form for a citizen petition in Sec. 10.30. For requests
involving administrative action, the request may be made in any written
form (e.g., letter, facsimile).
* * * * *
3. Section 10.30 is amended by revising paragraphs (b), (e)(1),
the introductory text of paragraph (e)(2), paragraph (e)(2)(ii), by
redesignating paragraph (e)(4) as (e)(5), and by adding a new paragraph
(e)(4) to read as follows:
Sec. 10.30 Citizen petition.
* * * * *
(b) A petition (including attachments) shall be submitted in
accordance with Sec. 10.20 and in the following form:
(Date) __________________________________
Dockets Management Branch (HFA-305), Food and Drug
Administration, Department of Health and Human Services, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852.
CITIZEN PETITION
The undersigned submits this petition under ____ (relevant
statutory sections, if known) of the ____ (Federal Food, Drug, and
Cosmetic Act or the Public Health Service Act or any other statutory
provision for which authority has been delegated to the
[[Page 66828]]
Commissioner of Food and Drugs under 21 CFR 5.10) to request that
the Commissioner of Food and Drugs ____ (issue, amend, or revoke a
regulation or amend or revoke an order that the agency has issued or
published or take an action as specifically provided by regulation).
A. Action requested
((1) If the petition requests that the Commissioner issue,
amend, or revoke a regulation, the exact wording of the existing
regulation (if any) and the proposed regulation or amendment
requested.)
((2) If the petition requests that the Commissioner amend or
revoke an order, the date on which the order was issued or
published, the exact wording and the citation for the existing order
and, if the request is to amend an order, the exact wording
requested for the amended order.)
((3) If the petition requests that the Commissioner take an
action, and a petition is specifically required by regulation, a
citation of the regulation and the specific action requested.)
B. Statement of grounds
(A full statement, in a well organized format, of the factual
and legal grounds on which the petitioner relies, including all
relevant information and views on which the petitioner relies, as
well as representative information known to the petitioner which is
unfavorable to the petitioner's position. Additionally, for
petitions requesting that FDA issue, amend, or revoke a regulation,
the petition shall show why the requested regulation pertains to a
subject that is appropriately addressed by regulation rather than
other administrative action. For petitions requesting that FDA amend
or revoke an order that was issued or published, the petition shall
be based on more than unsupported claims, allegations, or general
descriptions of positions or arguments.
C. Environmental impact
(A claim for categorical exclusion under Secs. 25.30, 25.31,
25.32, 25.33, or Sec. 25.34 of this chapter or an environmental
assessment under Sec. 25.40 of this chapter.)
D. Economic impact
(The following information is to be submitted only when
requested by the Commissioner following review of the petition: A
statement of the effect of the requested action on: (1) Cost (and
price) increases to industry, government, and consumers; (2)
productivity of wage earners, businesses, or government; (3)
competition; (4) supplies of important materials, products, or
services; (5) employment; and (6) energy supply or demand.)
E. Certification
The undersigned certifies, that, to the best knowledge and
belief of the undersigned, this petition includes all information
and views on which the petition relies, that it is well grounded in
fact and is warranted by existing laws or regulations, that it is
not submitted for any improper purpose, such as to harass or to
cause unnecessary delay, and that it includes representative data
and information known to the petitioner which are unfavorable to the
petition.
(Signature) __________________________
(Name of petitioner) __________________
(Mailing address) ____________________
(Telephone number)__________________
* * * * *
(e)(1) The Commissioner shall, in accordance with paragraph (e)(2)
of this section, act upon each petition filed under paragraph (c) of
this section, taking into consideration:
(i) Available agency resources for the category of subject matter;
(ii) The priority assigned to the petition considering both the
category of subject matter involved and the overall work of the agency;
and
(iii) Time requirements established by statute.
(2) Except as provided in paragraphs (e)(4) and (e)(5) of this
section, the Commissioner shall furnish a response to each petitioner
within 180 days of receipt of the petition. The response will either:
* * * * *
(ii) Deny the petition; the denial may be brief, as appropriate; or
* * * * *
(4) The Commissioner may:
(i) Refer a petition for other administrative action instead of
issuing a response. In such cases, the agency shall place a note in the
docket for the petition stating that the petition has been referred for
other administrative action and close the docket for the petition. FDA
may refer a petition for other administrative action if the petition:
(A) Involves issues that are the subject of an ongoing or future
administrative proceeding. In such cases, the agency may consider the
issues raised by the petition as part of the administrative record for
the administrative proceeding;
(B) Presents scientific or technical issues or data that are
specific to a particular product or class of products;
(C) Requests a regulation on an issue that is not appropriately
addressed by regulation;
(D) Does not involve a significant public health or consumer
protection issue; or
(E) Involves a subject that is appropriately addressed by other
administrative action.
(F) For petitions described in paragraphs (e)(4)(i)(B) through
(e)(4)(i)(E) of this section, the agency may treat the petition as
correspondence under Sec. 10.65.
(ii) Request clarification if the petition presents vague or
conflicting requests. If the petitioner does not respond to the request
for clarification within a time specified by FDA, the petition may be
considered withdrawn;
(iii) Consider the petition to be withdrawn if the petitioner no
longer exists or cannot be located or the petitioner has stated that it
does not seek a response from the agency; or
(iv) Combine petitions and supplements submitted by the same
petitioner or by different petitioners if those petitions concern the
same or similar subjects or products.
* * * * *
Dated: August 10, 1999.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning and Legislation.
[FR Doc. 99-30957 Filed 11-29-99; 8:45 am]
BILLING CODE 4160-01-F
