[Federal Register Volume 77, Number 33 (Friday, February 17, 2012)]
[Notices]
[Pages 9663-9664]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-3743]



[[Page 9663]]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0114]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Request for Samples and Protocols

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 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 information collection 
requirements relating to the regulations which state that protocols for 
samples of biological products must be submitted to the Agency.

DATES: Submit either electronic or written comments on the collection 
of information by April 17, 2012.

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.

Request for Samples and Protocols--(OMB Control Number 0910-0206)--
Extension

    Under section 351 of the Public Health Service Act (42 U.S.C. 262), 
FDA has the responsibility to issue regulations that prescribe 
standards designed to ensure the safety, purity, and potency of 
biological products and to ensure that the biologics licenses for such 
products are only issued when a product meets the prescribed standards. 
Under Sec.  610.2 (21 CFR 610.2), the Center for Biologics Evaluation 
and Research (CBER) or the Center for Drug Evaluation and Research may 
at any time require manufacturers of licensed biological products to 
submit to FDA samples of any lot along with the protocols showing the 
results of applicable tests prior to distributing the lot of the 
product. In addition to Sec.  610.2, there are other regulations that 
require the submission of samples and protocols for specific licensed 
biological products: Sec. Sec.  660.6 (21 CFR 660.6) (Antibody to 
Hepatitis B Surface Antigen); 660.36 (21 CFR 660.36) (Reagent Red Blood 
Cells); and 660.46 (21 CFR 660.46) (Hepatitis B Surface Antigen).
    Section 660.6(a) provides requirements for the frequency of 
submission of samples from each lot of Antibody to Hepatitis B Surface 
Antigen product, and Sec.  660.6(b) provides the requirements for the 
submission of a protocol containing specific information along with 
each required sample. For Sec.  660.6 products subject to official 
release by FDA, one sample from each filling of each lot is required to 
be submitted along with a protocol consisting of a summary of the 
history of manufacture of the product, including all results of each 
test for which test results are requested by CBER. After official 
release is no longer required, one sample along with a protocol is 
required to be submitted at 90-day intervals. In addition, samples, 
which must be accompanied by a protocol, may at any time be required to 
be submitted to CBER if continued evaluation is deemed necessary.
    Section 660.36(a) requires, after each routine establishment 
inspection by FDA, the submission of samples from a lot of final 
Reagent Red Blood Cell product along with a protocol containing 
specific information. Section 660.36(a)(2) requires that a protocol 
contain information including, but not limited to, manufacturing 
records, certain test records, and identity test results. Section 
660.36(b) requires a copy of the antigenic constitution matrix 
specifying the antigens present or absent to be submitted to the CBER 
Director at the time of initial distribution of each lot.
    Section 660.46(a) contains requirements as to the frequency of 
submission of samples from each lot of Hepatitis B Surface Antigen 
product, and Sec.  660.46(b) contains the requirements as to the 
submission of a protocol containing specific information along with 
each required sample. For Sec.  660.46 products subject to official 
release by FDA, one sample from each filling of each lot is required to 
be submitted along with a protocol consisting of a summary of the 
history of manufacture of the product, including all results of each 
test for which test results are requested by CBER. After notification 
of official release is received, one sample along with a protocol is 
required to be submitted at 90-day intervals. In addition, samples, 
which must be accompanied by a protocol, may at any time be required to 
be submitted to CBER if continued evaluation is deemed necessary.
    Samples and protocols are required by FDA to help ensure the 
safety, purity, or potency of a product because of the potential lot-
to-lot variability of a product produced from living organisms. In 
cases of certain biological products (e.g., Albumin, Plasma Protein 
Fraction, and therapeutic biological products) that are known to have 
lot-to-lot consistency, official lot release is not normally required. 
However,

[[Page 9664]]

submissions of samples and protocols of these products may still be 
required for surveillance, licensing, and export purposes, or in the 
event that FDA obtains information that the manufacturing process may 
not result in consistent quality of the product.
    The following burden estimate is for the protocols required to be 
submitted with each sample. The collection of samples is not a 
collection of information under 5 CFR 1320.3(h)(2). Respondents to the 
collection of information under Sec.  610.2 are manufacturers of 
licensed biological products. Respondents to the collection of 
information under Sec. Sec.  660.6(b), 660.36(a)(2) and (b), and 
660.46(b) are manufacturers of the specific products referenced 
previously in this document. The estimated number of respondents for 
each regulation is based on the annual number of manufacturers that 
submitted samples and protocols for biological products including 
submissions for lot release, surveillance, licensing, or export. Based 
on information obtained from FDA's database system, approximately 77 
manufacturers submitted samples and protocols in fiscal year (FY) 2011, 
under the regulations cited previously in this document. FDA estimates 
that approximately 73 manufacturers submitted protocols under Sec.  
610.2 and 2 manufacturers submitted protocols under the regulation 
(Sec.  660.6) for the other specific product. FDA received no 
submissions under Sec.  660.36 or Sec.  660.46; however, FDA is using 
the estimate of one protocol submission under each regulation in the 
event that protocols are submitted in the future.
    The estimated total annual responses are based on FDA's final 
actions completed in FY 2011 for the various submission requirements of 
samples and protocols for the licensed biological products. The average 
burden per response is based on information provided by industry. The 
burden estimates provided by industry ranged from 1 to 5.5 hours. Under 
Sec.  610.2, the average burden per response is based on the average of 
these estimates and rounded to 3 hours. Under the remaining 
regulations, the average burden per response is based on the higher end 
of the estimate (rounded to 5 or 6 hours) since more information is 
generally required to be submitted in the other protocols than under 
Sec.  610.2.
    FDA estimates the burden of this information collection as follows:

                                  Table 1--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                                                      No. of                          Average
         21 CFR section               No. of       responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
610.2...........................              73            92.9           6,782               3          20,346
660.6(b)........................               2            21.5              43               5             215
660.36(a)(2) and (b)............               1               1               1               6               6
660.46(b).......................               1               1               1               5               5
                                 -------------------------------------------------------------------------------
    Total.......................              77  ..............           6,827  ..............          20,572
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: February 10, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-3743 Filed 2-16-12; 8:45 am]
BILLING CODE 4160-01-P