[Federal Register Volume 71, Number 125 (Thursday, June 29, 2006)]
[Notices]
[Pages 37080-37082]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-5805]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0021]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Request for Samples 
and Protocols

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 
31, 2006.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. 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: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-4659.

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.

[[Page 37081]]

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 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), FDA 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 marketing 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.  
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 the Center for Biologics 
Evaluation and Research (CBER). After official release is no longer 
required, one sample along with a protocol is required to be submitted 
at an interval of 90 days. In addition, samples, which must be 
accompanied by a protocol, may at any time be required to be submitted 
to FDA 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, test records, and test results. Section 660.36(b) requires a 
copy of the antigenic constitution matrix specifying the antigens 
present or absent to be submitted to FDA at the time of initial 
distribution of each lot.
    Section 660.46(a) provides requirements for the frequency of 
submission of samples from each lot of Hepatitis B Surface Antigen 
product, and Sec.  660.46(b) provides the requirements for 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 an interval of 90 days. In addition, 
samples, which must be accompanied by a protocol, may at any time be 
required to be submitted to FDA if continued evaluation is deemed 
necessary.
    Samples and protocols are required by FDA to help ensure the 
product meets the criteria for lot release that have been determined to 
be necessary by FDA. In cases of certain biological products (e.g., 
Albumin, Plasma Protein Fraction, and specified biotechnology and 
specified synthetic biological products) that are known to have lot-to-
lot consistency, official lot release is not normally required. 
However, 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 that are 
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.  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 70 manufacturer's 
submitted samples and protocols in fiscal year (FY) 2005, under the 
regulations cited previously in this document. FDA estimates that 65 
manufacturers submitted protocols under Sec.  610.2, and 4 
manufacturers submitted protocols under the regulations (Sec. Sec.  
660.6 and 660.46) for the other specific products. FDA received no 
submissions under Sec.  660.36, however FDA is using the estimate of 
one protocol submission in the event one is submitted in the future.
    The estimated total annual responses are based on FDA's final 
actions completed in FY 2005, which totaled 4,930, for the various 
submission requirements of samples and protocols for the licensed 
biological products. The rate of final actions is not expected to 
change significantly in the next few years. The hours per response are 
based on information provided by industry. The burden estimates 
provided by industry ranged from 1 to 5.5 hours. Under Sec.  610.2, the 
hours per response are based on the average of these estimates and 
rounded to 3 hours. Under the remaining regulations, the hours per 
response are 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 protocol than under Sec.  610.2.
    In the Federal Register of January 24, 2006 (71 FR 3856), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                              No. of         Annual Frequency       Total Annual        Hours per
                    21 CFR Section                         Respondents         per Response          Responses          Respondent        Total Hours
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610.2                                                                  65                  74.1              4,816                  3             14,448
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660.6(b)                                                                3                    26                 78                  5                390
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[[Page 37082]]

 
660.36(a)(2) and (b)                                                    1                     1                  1                  6                  6
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660.46(b)                                                               1                    35                 35                  5                175
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Total                                                                  70  ....................  .................  .................             15,019
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: June 23, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 06-5805 Filed 6-28-06; 8:45 am]
BILLING CODE 4160-01-S