
[Federal Register Volume 77, Number 230 (Thursday, November 29, 2012)]
[Notices]
[Pages 71193-71194]
From the Federal Register Online via the Government Printing 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, Ila.Mizrachi@fda.hhs.gov.

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]
BILLING CODE 4160-01-P


