[Federal Register Volume 62, Number 104 (Friday, May 30, 1997)]
[Notices]
[Pages 29353-29355]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-14140]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97N-0182]


Agency Information Collection Activities: Proposed Collections; 
Comment Request; Reinstatements

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 collections 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 reinstatement of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on information collection 
provisions relating to the regulation that samples and protocols of 
biological products may be required to be submitted to the agency, and 
Transmittal of Labels and Circulars, Form FDA 2657.

DATES: Submit written comments on the collections of information by 
July 29, 1997.

ADDRESSES: Submit written comments on the collections of information to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. All comments should 
be identified with the docket number found in brackets in the heading 
of this document.

FOR FURTHER INFORMATION CONTACT: Margaret R. Wolff, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, rm. 16B-19, Rockville, MD 20857, 
301-827-1223.

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 reinstatement 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 collections 
of information listed below.
    With respect to each of the following collections of information, 
FDA invites comments on: (1) Whether the proposed collections of 
information are necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimates of the burdens of the 
proposed collections of information, including the validity of the 
methodology and assumptions used;

[[Page 29354]]

(3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burdens of 
the collections of information on respondents, including through the 
use of automated collection techniques, when appropriate, and other 
forms of information technology.

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 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 
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.
    FDA estimates the burden of this information collection as follows:

                                        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 has the responsibility to 
ensure the safety, purity, potency and effectiveness of biological 
products. Part of this responsibility includes the review and approval 
of all 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:

                                        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   60l.2(a) and          387               7.2         2,800                .16          448       
 Transmittal     601.12(a)                                                                                      
 of Labels and                                                                                                  
 Circulars                                                                                                      
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There are no capital costs or operating and maintenance costs associated with this information collection of    
  information.                                                                                                  



[[Page 29355]]

    Dated: May 23, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-14140 Filed 5-29-97; 8:45 am]
BILLING CODE 4160-01-F