[Federal Register Volume 68, Number 98 (Wednesday, May 21, 2003)]
[Notices]
[Pages 27820-27821]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-12724]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0516]


Agency Information Collection Activities; Submission for OMB 
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 the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Fax or electronically mail written comments on the collection of 
information by June 20, 2003.

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 
electronically mailed to [email protected] or faxed to the Office of 
Information and Regulatory Affairs, OMB, Attn: Stuart Shapiro, Desk 
Officer for FDA, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: JonnaLynn P. Capezzuto, Office of 
Information Resources Management (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.

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 applicable tests before 
marketing the lot of the product. In addition to Sec.  610.2, there are 
other regulations in part 660 (21 CFR part 660) that require the 
submission of samples and protocols for specific licensed biological 
products: Sec. Sec.  660.6 (Antibody to Hepatitis B Surface Antigen), 
660.36 (Reagent Red Blood Cells), and 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

[[Page 27821]]

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 
previously. 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 years 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 years 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.
    In the Federal Register of December 27, 2002 (67 FR 79127), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. FDA received one comment on the information 
collection in response to the 60-day notice.
    The comment recommended that we should review the regulations under 
Sec.  610.2(a) concerning lot release and consider modifications to 
reflect current manufacturing technology standards in light of 
industry's ability to control and test products to ensure identity, 
purity, and potency. The comment provided some suggestions to consider 
regarding the lot release requirements.
    The comment's suggested regulatory revisions that pertain to 
provisions or matters that are outside the scope of the proposed 
information collection. Consequently, we decline to adopt the comment's 
recommendations.
    FDA estimates the burden of this information collection 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           response         Total hours
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610.2                            76               86.5               6,574                  3             19,722
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660.6(b)                          4               28.5                 114                  5                570
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660.36(a)(2) and                  1                1                     1                  6                  6
 (b)
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660.46(b)                         2               29                    58                  5                290
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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 of
  information.


    Dated: May 15, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-12724 Filed 5-20-03; 8:45 am]
BILLING CODE 4160-01-S