[Federal Register Volume 61, Number 108 (Tuesday, June 4, 1996)]
[Proposed Rules]
[Pages 28116-28118]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-13980]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 1, 2, 3, 5, 10, 12, 20, 56, and 58
[Docket No. 96N-0163]
RIN 0910-AA69
Reinvention of Administrative Procedures Regulations
AGENCY: Food and Drug Administration, HHS.
ACTION: Advance notice of proposed rulemaking.
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SUMMARY: The Food and Drug Administration (FDA) is considering ways to
further streamline its administrative procedures regulations as a
result of a page-by-page review of the agency's regulations. This
regulatory review is part of the administration's ``Reinventing
Government'' initiative that seeks to streamline Government and to ease
the burden on regulated industry and consumers. FDA is seeking public
comment on ways to streamline its administrative procedures
regulations.
DATES: Written comments by September 3, 1996.
[[Page 28117]]
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT:
Regarding information concerning the regulations: Philip L. Chao,
Policy Development and Coordination Staff (HF-23), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3380.
Regarding general information on FDA's ``reinventing initiative'':
Lisa M. Helmanis, Regulations Policy Management Staff (HF-26), Food and
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-
3480.
SUPPLEMENTARY INFORMATION: On March 4, 1995, President Clinton
announced plans for reforming the Federal regulatory system as part of
his ``Reinventing Government'' initiative. In his March 4, 1995,
directive, the President ordered all Federal agencies to conduct a
page-by-page review of their regulations and to ``eliminate or revise
those that are outdated or otherwise in need of reform.'' This notice
represents FDA's continuing effort to implement the President's plan.
In previous issues of the Federal Register, FDA proposed revoking or
revising other regulations; the agency expects to issue additional
reinvention proposals in the future.
In this notice, FDA is seeking comments on ways listed in the table
below in which its administrative regulations could be updated or
revised in order to streamline the agency's administrative practices
and procedures.
The following table contains a section-by-section analysis of the
regulations that FDA is considering ``reinventing.'' These regulations
are listed numerically as they appear in the Code of Federal
Regulations (CFR).
Section-by-Section Analysis of Regulations Under Consideration
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Description or
21 CFR Cite Title of Explanation of
Regulation Reinvention
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Sec. 1.3..................... Defines label and Should the
labeling. definitions be
amended? There are
only two definitions
(label and labeling)
involved, but they
could be updated to
be more consistent
with current
statutory language.
Sec. 1.21.................... Describes what This section provides
constitutes a general information
failure to on failures to
reveal a reveal material
material fact. facts. Should this
section be revised,
expanded, or
removed?
Sec. 1.23.................... Describes This provision could
procedures for be rewritten to
requesting a remove extraneous
variance or material and to
exemption from provide better
required label instructions on
statements. procedures for a
variance or
exemption.
Sec. 1.24.................... Lists granted Because much of the
label exemptions text is devoted to
for foods, foods, the provision
animal drugs, could be relocated
and cosmetics. to that part of the
CFR devoted to
foods. Similar moves
could be made for
the paragraphs on
animal drugs and
cosmetics. Would it
be more useful to
move these
provisions to the
corresponding
subject areas?
Sec. 1.90.................... Notice of This section explains
sampling. the procedures for
notification of
sampling of imports.
Should this section
be consolidated with
Sec. 1.91?
Sec. 1.91.................... Payment for This section provides
samples. that FDA will pay
for import samples
of nonviolative
goods.
Sec. 2.125................... Establishes Should this provision
procedures to be modified to
permit the use reflect current
of requirements under
chlorofluorocarb the Clean Air Act
ons (CFC's) in and to correspond
self-pressurized with the
containers. Environmental
Protection Agency
regulations on CFC
use and warning
labels?
Sec. 3.6..................... States who the This section should
product be amended to
jurisdiction reflect the current
officer is. information.
Part 5........................ Delegations of Some of the
authority. delegations of
authority refer to
offices or titles
that no longer exist
or have changed due
to reorganizations.
This part should be
revised to reflect
the most current
information. Does it
remain useful to
codify these
delegations of
authority?
Part 10 subparts A and B...... Administrative These regulations
practices and govern the practices
procedures. and procedures for
petitions, hearings,
and other
administrative
proceedings and
activities conducted
by FDA. Some
sections should be
revised to provide
more flexibility or
efficiency. For
example, could FDA's
citizen petitions
process be made more
efficient?
Part 12....................... Formal Should FDA's
evidentiary regulations
public hearing. governing formal
hearings be
simplified or
clarified?
Part 20....................... Public This part governs
information. FDA's communication
with the public.
Does this part
continue to reflect
the best way for FDA
to handle public
information? Are
there better, more
efficient approaches
that should be
embodied in FDA's
regulations?
Sec. 56.104.................. Describes The first two exempt
exemptions from classes are probably
institutional inapplicable today
review boards because they refer
requirements. to clinical research
begun before July
27, 1981. Should
this section be
amended by removing
paragraphs (a) and
(b)?
Part 58....................... Good laboratory This part describes
practice fundamental
regulations. principles for
laboratories to
observe and are
intended to ensure
the quality and
integrity of safety
data. Updating to
reflect current
technology (such as
greater use of
computers) may be
needed.
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Interested persons may, on or before, September 3, 1996, submit to
the Dockets Management Branch (address above) written comments
regarding this advance notice of proposed rulemaking (ANPRM). 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.
[[Page 28118]]
This ANPRM is issued under section 301 et seq. of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) and under the authority
of the Commissioner of Food and Drugs.
Dated: May 28, 1996.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 96-13980 Filed 6-3-96; 8:45 am]
BILLING CODE 4160-01-F
