[Federal Register Volume 62, Number 182 (Friday, September 19, 1997)]
[Notices]
[Pages 49244-49246]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-24954]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97N-0182]
Agency Information Collection Activities; Submission for OMB
Review; Comment Request
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that the
proposed collections of information listed below have been
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submitted to the Office of Management and Budget (OMB) for review and
clearance under the Paperwork Reduction Act of 1995 (the PRA).
DATES: Submit written comments on the collection of information by
October 20, 1997.
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:
Desk Officer for FDA.
FOR FURTHER INFORMATION CONTACT: Margaret R. Wolff, Office of
Information Resources Management (HFA-250), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.
SUPPLEMENTARY INFORMATION: In compliance with section 3507 of the PRA
(44 U.S.C. 3507), FDA has submitted the following proposed collections
of information to OMB for review and clearance.
1. Requests for Samples and Protocols: Official Release--(OMB
Control Number 0910-0206--Reinstatement)
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 assure 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.
Since January 8, 1948, there has been a regulation, now codified
under Sec. 610.2 (21 CFR 610.2), that gives authority to FDA to require
manufacturers of licensed biological products to submit lot samples and
protocols prior to marketing the lot of product. These lot samples and
protocols are required by FDA when necessary for the safety, purity, or
potency of the product. This requirement remains essential because of
the potential lot-to-lot variability of many biological products. 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 stability,
official lot release is normally not required. In addition to
Sec. 610.2, there are other regulations that require additional
standards for the submission of samples and protocols for specific
licensed biological products: Secs. 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).
Respondents to this collection of information are manufacturers of
licensed biological products that are subject to lot release.
Approximately 80 manufacturers are subject to lot release. Previously,
90 firms were subject to lot release, however, 10 of those firms have
been exempted from this reporting requirement because the firms
manufacture specified biotechnology and/or specified synthetic
biological products. FDA estimates are based on data on lot releases
submitted in fiscal year 1995. The estimated burdens for
Secs. 640.101(f), 660.6, 660.36, and 660.46 are included in the
estimated annual reporting burden for Sec. 610.2.
In the Federal Register of May 30, 1997 (62 FR 29353), the agency
requested comments on the proposed collection of information for
``Requests for Samples and Protocols: Official Release.'' The agency
received one comment, which suggested a higher estimated average for
the time to prepare a protocol for submission to FDA than the agency
had estimated. Subsequently, FDA contacted another representative from
industry in August 1997 regarding the lot release requirements for
Sec. 610.2. The average time estimated herein was adjusted accordingly
to reflect the comment received and all four contacts with industry.
The burden estimate ranged from 1 to 5.6 hours and the average was
rounded to 3 hours.
FDA estimates the burden of this information collection as
follows:
Table 1.--Estimated Annual Reporting Burden
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Annual
21 CFR Section No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
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610.2 80 75 6,500 1 6,500
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There are no capital costs or operating and maintenance costs associated with this collection of information.
2. Transmittal of Labels and Circulars, Form FDA 2567--21 CFR
601.2(a) and 601.12(a) (OMB Control Number 0910-0039--
Reinstatement)
Under section 351 of the PHS Act, FDA reviews the labeling for
biological products prior to marketing of the licensed product and when
changes to labeling are proposed. Section 601.2(a) (21 CFR 601.2(a))
requires manufacturers of biological products to submit an
establishment and product, or biologics license application for review
and approval to the Center for Biologics Evaluation and Research (CBER)
prior to marketing a biological product in interstate commerce.
Specimens of the label are required to be submitted as part of the
approval process. Section 601.12(a) (21 CFR 601.12(a)) requires
proposed changes to labeling to be submitted to CBER for approval. For
these labeling requirements, Form FDA 2567 is used to determine the
type of labeling being submitted (container label, package label,
diluent label and/or circular) and the type of change(s) to the
labeling. This form is also used for the submission of advertising and
promotion labeling. The form is composed of two parts: Part I is for
the submission of draft and preliminary proof labeling and is completed
by manufacturers of biological products, and Part II of the form is
submitted upon implementation of final printed labeling. Parts I and II
of the form are submitted separately. Respondents to this collection of
information are manufacturers of biological products.
FDA estimates the burden of this collection of information as
follows:
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Table 2.--Estimated Annual Reporting Burden
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Annual
Form No. 21 CFR Section No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
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FDA Form 2657 Transmittal of Labels and
Circulars 601.2(a) and 601.12(a) 387 7.2 2,800 .16 448
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There are no capital costs or operating and maintenance costs associated with this information collection of information.
Dated: September 12, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-24954 Filed 9-18-97; 8:45 am]
BILLING CODE 4160-01-F
