[Federal Register Volume 67, Number 249 (Friday, December 27, 2002)]
[Notices]
[Pages 79127-79129]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-32749]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0516]


Agency Information Collection Activities; Proposed Collection; 
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 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 
provisions relating to the regulations which state that protocols for 
samples of biological products must be submitted to the agency.

DATES: Submit written or electronic comments on the collection of 
information by February 25, 2003.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm. 
Submit written comments on the collection of information to the Dockets 
Management Branch (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: JonnaLynn P. Capezzuto, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, rm. 16B-26, Rockville, MD 20857, 
301-827-4659.

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 listed below.
    With respect to the following collection of information, FDA 
invites comments on: (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 (the PHS 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 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

[[Page 79128]]

applicable tests before 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), 
Sec.  660.36 (21 CFR 660.36) (Reagent Red Blood Cells), and Sec.  
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 or 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 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 or 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 
safety, purity, or potency of the 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 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 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 any 
licensed biological product. 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 above. 
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. There are an estimated 329 
manufacturers of licensed biological products, however, based on 
information obtained from FDA's database system, approximately 83 
manufacturers submitted samples and protocols in fiscal year 1999 and 
2000, under the regulations cited previously. FDA estimates that 
approximately 76 manufacturers submitted protocols under Sec.  610.2 
and 7 manufacturers submitted protocols under the regulations for the 
specific products.
    The total annual responses are based on the annual average of FDA's 
final actions completed in fiscal year 1999 and 2000, which totaled 
6,747, for the various submission requirements of samples and protocols 
for 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) because more information is generally required to be submitted 
in the protocol than under Sec.  610.2. FDA estimates the burden of 
this information collection as follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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 21 CFR                            Annual Frequency per    Total Annual
 Section    No. of Respondents           Response            Response       Hours per Response      Total Hours
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610.2              76                      86.5             6,574                   3              19,722
660.6(b)            4                      28.5               114                   5                 570
660.36(a            1                       1                   1                   6                   6
 )(2)
 and (b)
660.46(b            2                      29                  58                   5                 290
 )
Total              83             ......................    6,747         ......................   20,588
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\1\ There are no capital costs or operating and maintenance costs associated with this collection.



[[Page 79129]]

    Dated: December 19, 2002.
Margaret M. Dotzel,
Assistant Commissioner for Policy.
[FR Doc. 02-32749 Filed 12-26-02; 8:45 am]
BILLING CODE 4160-01-S