[Federal Register Volume 77, Number 230 (Thursday, November 29, 2012)]
[Notices]
[Pages 71193-71194]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-28907]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0099]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Revision of the Requirements for Constituent Materials
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 regarding the requirement for the
use of constituent materials in licensed biological products.
DATES: Submit either electronic or written comments on the collection
of information by January 28, 2013.
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: Ila S. Mizrachi, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B,
Rockville, MD 20850, 301-796-7726, [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.
Revision of the Requirements for Constituent Materials in Biological
Products--21 CFR 610.15(d) (OMB Control Number 0910-0666)--Extension
In the Federal Register of April 13, 2011 (76 FR 20513), FDA issued
a final rule amending the regulation for the use of constituent
materials in licensed biological products. Under 21 CFR 610.15(d), the
Director of the Center for Biologics Evaluation and Research (CBER) or
the Director of the Center for Drugs Evaluation and Research (CDER) may
approve, as appropriate, a manufacturer's request for exceptions or
alternatives to the regulation for constituent materials. Thus, the
provision provides manufacturers of biological products with
flexibility, as appropriate, to employ advances in science and
technology as they become available, without diminishing public health
protections. Manufacturers seeking approval of an exception or
alternative must submit a request in writing. The request must be
clearly identified with a brief statement describing the basis for the
request and the supporting data. The request may be submitted as part
of the original biologics application, as an amendment to the original,
pending application or as a prior approval supplement to an approved
application. The information to be collected assists FDA in identifying
and reviewing requests for an exception or alternative to the
requirements for constituent materials.
Respondents to this information collection provision are
manufacturers of biological products. Since implementation of the final
rule, FDA has received no submissions of requests for an exception or
alternative for constituent materials. Therefore, FDA is estimating one
respondent and annual response annually to account for a possible
submission to CBER or CDER of a request for an exception or alternative
for constituent materials. The average burden per response is based on
FDA experience with similar information collection requirements.
FDA estimates the burden of this collection of information as
follows:
[[Page 71194]]
Table 1--Estimated Annual Reporting Burden \1\
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No. of
21 CFR section No. of responses per Total annual Average burden Total hours
respondents respondent responses per response
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610.15............................................................. 1 1 1 1 1
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: November 26, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-28907 Filed 11-28-12; 8:45 am]
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