[Federal Register Volume 63, Number 2 (Monday, January 5, 1998)]
[Notices]
[Pages 230-231]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-10]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97N-0513]
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed reinstatement of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on provisions concerning orphan
drugs.
DATES: Submit written comments on the collection of information by
March 6, 1998.
ADDRESSES: Submit written comments on the collection of information to
the Dockets Management Branch (HFA-305), Food and Drug Administration,
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. All comments should
be identified with the docket number found in brackets in the heading
of this document.
FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Information
Resources Management (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-1472.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed reinstatement of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information listed below.
With respect to the following collection of information, FDA
invites comments on: (1) Whether the proposed 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 proposed 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.
[[Page 231]]
Orphan Drugs--(21 CFR Part 316)--(OMB Control Number 0910-0167--
Reinstatement)
Sections 525 through 528 of the Federal Food, Drug, and Cosmetic
Act (the act) (21 U.S.C. 360aa through 360dd) give the FDA statutory
authority to: (1) Provide recommendations on investigations required
for approval of marketing applications for orphan drugs, (2) designate
eligible drugs as orphan drugs, (3) set forth conditions under which a
sponsor of an approved orphan drug obtains exclusive approval, and (4)
encourage sponsors to make orphan drugs available for treatment on an
``open protocol'' basis before the drug has been approved for general
marketing. The implementing regulations for these statutory
requirements have been codified under part 316 (21 CFR part 316) and
specify procedures that sponsors of orphan drugs use in availing
themselves of the incentives provided for orphan drugs in the act and
sets forth procedures FDA will use in administering the act with regard
to orphan drugs. Section 316.10 specifies the content and format of a
request for written recommendations concerning the nonclinical
laboratory studies and clinical investigations necessary for approval
of marketing applications. Section 316.12 provides that, before
providing such recommendations, FDA may require results of studies to
be submitted for review. Section 316.14 contains provisions permitting
FDA to refuse to provide written recommendations under certain
circumstances. Within 90 days of any refusal, a sponsor may submit
additional information specified by FDA. Section 316.20 specifies the
content and format of an orphan drug application which includes
requirements that an applicant document that the disease is rare
(affects fewer than 200,000 persons in the United States annually) or
that the sponsor of the drug has no reasonable expectation of
recovering costs of research and development of the drug. Section
316.26 allows an applicant to amend the application under certain
circumstances. Section 316.30 requires submission of annual reports,
including progress reports on studies, a description of the
investigational plan, and a discussion of changes that may affect
orphan status. The information requested will provide the basis for an
FDA determination that the drug is for a rare disease or condition and
satisfies the requirements for obtaining orphan drug status. Secondly,
the information will describe the medical and regulatory history of the
drug. The respondents to this collection of information are
biotechnology firms, drug companies, and academic clinical researchers.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden1
----------------------------------------------------------------------------------------------------------------
Annual
21 CFR Section No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
----------------------------------------------------------------------------------------------------------------
316.10, 316.12, and 316.14 0 0 0 0 0
316.20, 316.21, and 316.26 90 1.78 160.20 125 20,025
316.22 5 1 5 2 10
316.27 5 1 5 4 20
316.30 450 1 450 2 900
316.36 .2 3 .6 15 9
Total 20,964
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The information requested from respondents represents, for the most
part, an accounting of information already in possession of the
applicant. It is estimated, based on the frequency of requests over the
past 5 years, that 90 persons or organizations per year will request
orphan drug designation and that no requests for recommendations on
design of preclinical or clinical studies will be received. Based upon
FDA experience over the last decade, FDA estimates that the effort
required to prepare applications to receive consideration for sections
525 and 526 of the act (21 CFR 316.10, 316.12, 316.20, and 316.21) is
generally similar and is estimated to require an average of 95 hours of
professional staff time and 30 hours of support staff time per
application. Estimates of annual activity and burden for foreign
sponsor nomination of a resident, agent, change in ownership or
designation, and inadequate supplies of drug in exclusivity, are based
on total experience by FDA with such requests since 1983.
Dated: December 23, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-10 Filed 1-2-98; 8:45 am]
BILLING CODE 4160-01-F
