[Federal Register Volume 76, Number 14 (Friday, January 21, 2011)]
[Notices]
[Pages 3910-3912]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-1270]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0015]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Orphan Drugs; Common European Medicines Agency/Food
and Drug Administration Application Form for Orphan Medicinal Product
Designation (Form FDA 3671)
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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 extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the procedures by which
sponsors of orphan drugs may request eligibility for the incentives by
implementing a program as outlined in the Orphan Drug Act and the joint
adoption by FDA and the European Medicines Agency (EMA) of the Common
EMA/FDA Application Form for Orphan Medicinal Product Designation (form
FDA 3671).
DATES: Submit either electronic or written comments on the collection
of information by March 22, 2011.
ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B,
Rockville, MD 20850. 301-796-3794. [email protected].
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 extension 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 set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (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 3911]]
Orphan Drugs; Common EMA/FDA Application Form for Orphan Medicinal
Product Designation (Form FDA 3671)--21 CFR Part 316 (OMB Control
Number 0910-0167)--Extension
Sections 525 through 528 of the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C. 360aa through 360dd) give FDA statutory
authority to do the following: (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 FD&C Act and sets forth procedures FDA will use in
administering the FD&C Act with regard to orphan drugs. Section 316.10
specifies the content and format of a request for written
recommendations concerning the non-clinical 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. Based on past experience, FDA estimates that there
will be two respondents to Sec. Sec. 316.10, 316.12, and 316.14
requiring 200 hours of human resources annually.
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 316.21 specifies content of a request for orphan drug
designation required for verification of orphan-drug status. Section
316.26 allows an applicant to amend the applications under certain
circumstances. The Common EMA/FDA Application Form for Orphan Medicinal
Product Designation (form FDA 3671) is intended to benefit sponsors who
desire to seek orphan designation of drugs intended for rare diseases
or conditions from both the European Commission and FDA by reducing the
burden of preparing separate applications to meet the regulatory
requirements in each jurisdiction. It highlights the regulatory
cooperation between the United States (U.S.) and the European Union
(EU) mandated by the Transatlantic Economic Council (TEC). FDA does not
believe the new form will result in any increased burden on the
respondents and therefore we estimate no additional burden. Based on
past experience, FDA estimates there will be 214 respondents requiring
64,200 hours of human resources annually. Section 316.22 specifies
requirement of a permanent resident agent for foreign sponsors. Based
on past experience, FDA estimates 55 respondents requiring 110 hours of
human resources annually. Section 316.27 specifies content of a change
in ownership of orphan-drug designation. Based on past experience, FDA
estimates 43 respondents requiring 215 hours of human resources
annually. 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. Based on number of orphan-drug designations, the number
of respondents is estimated as 1,652 requiring 4,956 hours of human
resources annually. Finally, Sec. 316.36 describes information
required of sponsor when there is insufficient quantity of approved
orphan drug. Based on past experience, FDA estimates one respondent
requiring 45 hours of human resources annually.
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 Burden \1\
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Number of Annual frequency Total annual Hours per
21 CFR Section and FDA Form respondents per response responses response Total hours
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316.10, 316.12, and 316.14.................................... 2 1 2 100 200
316.20, 316.21, and 316.26; Form FDA 3671..................... 214 2 428 150 64,200
316.22........................................................ 55 1 55 2 110
316.27........................................................ 43 1 43 5 215
316.30........................................................ 1,652 1 1,652 3 4,956
316.36........................................................ 1 3 3 15 45
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Total..................................................... ................ ................ ................ ................ 69,726
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 3912]]
Dated: January 18, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-1270 Filed 1-20-11; 8:45 am]
BILLING CODE 4160-01-P