
[Federal Register Volume 78, Number 108 (Wednesday, June 5, 2013)]
[Notices]
[Pages 33845-33846]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-13247]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0099]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Revision of the 
Requirements for Constituent Materials

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by July 5, 
2013.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0666. 
Also include the FDA 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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Revision of the Requirements for Constituent Materials--(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.
    In the Federal Register of November 29, 2012 (77 FR 71193), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of
                           21 CFR Section                               Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
610.15.............................................................               1                1                1                1                1
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.



[[Page 33846]]

    Dated: May 30, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-13247 Filed 6-4-13; 8:45 am]
BILLING CODE 4160-01-P


