[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

[[Page 49245]]

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:

[[Page 49246]]



                                                       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