[Federal Register Volume 65, Number 130 (Thursday, July 6, 2000)]
[Notices]
[Pages 41678-41679]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-16975]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-0928]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Request for Samples and Protocols

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

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: Submit written comments on the collection of information by 
August 7, 2000.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Wendy Taylor, Desk Officer for FDA.

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 (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 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 as follows: Sections 
640.101(f) (21 CFR 640.101(f)) (Immune Globulin (Human)), 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 640.101(f)(2) requires for each lot of Immune Globulin 
(Human) product, the submission of all protocols relating to the 
history of the product and all results of all tests prescribed in the 
additional standards for the product.
    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 
containing 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

[[Page 41679]]

collection of information under Secs. 640.101(f)(2), 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 350 manufacturers of licensed biological products, 
however, based on information obtained from FDA's data base system, 
approximately 100 manufacturers submitted samples and protocols in 
1998, under the regulations cited previously. FDA estimates that 
approximately 86 manufacturers submitted protocols under Sec. 610.2, 
and 14 manufacturers submitted protocols under the regulations for the 
specific products. FDA had previously estimated 80, instead of 90, 
manufacturers would submit samples and protocols annually under all the 
regulations cited previously to account for biotechnology firms that 
are exempt from lot release requirements. Because biotechnology firms 
may still be required to submit samples and protocols for purposes 
other than lot release, as explained previously, the number of 
respondents for Sec. 610.2 in this estimate includes them. The slight 
increase in the total estimated number of respondents (100) is due to a 
normal variation in annual submissions.
    The total annual responses are based on FDA's final actions 
completed in fiscal year 1998, which totaled 7,221, 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) since 
more information is generally required to be submitted in the protocol 
than under Sec. 610.2.
    In the Federal Register of March 22, 2000 (65 FR 15341), the agency 
requested comments on the proposed collection of information. No 
significant comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                  Table 1.--Estimated Annual Reporting Burden<SUP>1</SUP>
----------------------------------------------------------------------------------------------------------------
                                                      Annual
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours
                                    Respondents      Response        Responses       Response
----------------------------------------------------------------------------------------------------------------
610.2                                  86              82.72        7,114               3          21,342
640.101(f)(2)                           5               4.40           22               5             110
660.6(b)                                6              11.33           68               5             340
660.36(a)(2) and (b)                    1               1               1               6               6
660.46(b)                               2               8              16               5              80
Total                                 100                           7,221                         21,878
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: June 27, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-16975 Filed 7-5-00; 8:45 am]
BILLING CODE 4160-01-F