[Federal Register Volume 68, Number 140 (Tuesday, July 22, 2003)]
[Notices]
[Pages 43359-43361]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-18503]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003N-0302]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Certain Biologics Labeling

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 collection 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 and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on the information collection requirements 
related to certain biologics labeling requirements.

DATES:  Submit written or electronic comments on the collection of 
information by September 22, 2003.

ADDRESSES:  Submit electronic comments on the collection of information 
to http://www.fda.gov/dockets/ecomments. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of 
Management Programs (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-4659.

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 before 
submitting the collection to OMB for approval. To comply with this 
requirement, FDA is publishing notice of the proposed collection of 
information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on: (1) Whether the proposed collection of information 
is necessary for the proper performance of FDA's functions, including 
whether the information will have practical utility; (2) the accuracy 
of FDA's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques when appropriate, and other forms of 
information technology.

Certain Biologics Labeling

    Under the authority of section 351 of the Public Health Services 
Act (PHS Act) (42 U.S.C. 262), the biologics regulations require a 
manufacturer of a biological product to submit an application with 
accompanying information, including labeling information, to FDA for 
approval to market a product in interstate commerce part 601.2 (21 CFR 
part 601.2). In addition, any changes to labeling are required to be 
submitted to FDA for review and approval (Sec.  601.12). For

[[Page 43360]]

biological products, excluding blood and blood components for 
transfusion, the container and package labeling requirements subject to 
the PRA are provided in part 610.60 (21 CFR part 610.60) Sec. Sec.  
610.61, and Sec.  610.62. The collections of information under 
Sec. Sec.  601.2, 601.12, 610.60, 610.61, and 610.62 are approved under 
OMB control number 0910-0338 (expires August 31, 2005). In addition to 
the labeling requirements prescribed in Sec. Sec.  610.60 through 
610.62 or other labeling regulations (e.g., Sec.  809.10), there are 
additional container and/or package labeling requirements for certain 
licensed biological products subject to the PRA: Sec. Sec.  640.70 and 
640.74 (21 CFR 640.70 and 640.74) (Source Plasma), Sec.  640.84 
(Albumin), Sec.  640.94 (Plasma Protein Fraction), Sec.  660.2 
(Antibody to Hepatitis B Surface Antigen), Sec.  660.28 (Blood Grouping 
Reagent), Sec.  660.35 (Reagent Red Blood Cells), Sec.  660.45 
(Hepatitis B Surface Antigen), and Sec.  660.55 (Anti-Human Globulin).
    An example of an additional labeling requirement for each of the 
specific regulations is as follows:
    [sbull] Section 640.70(a), the total volume or weight of plasma.
    [sbull] Section 640.74(b)(3) and (4), the name of the manufacturer 
of the final blood derivative product for whom it was prepared.
    [sbull] Sections 640.84(a) and (c), and 640.94(a), the osmotic 
equivalent.
    [sbull] Section 660.2(c), name of the recommended test method(s).
    [sbull] Section 660.28(a) and (b), the name of the antibody or 
antibodies present.
    [sbull] Section 660.35(a), (c) through (g), and (i) through (m), 
information regarding washing of cells, percentage of red blood cells 
in suspension.
    [sbull] Section 660.45, name of the recommended test method(s).
    [sbull] Section 660.55(a) and (b), the name of the antibody or 
antibodies present.
    Form FDA 2567 ``Transmittal of Labels and Circulars'' is used by 
manufacturers of licensed biological products to submit with labeling 
(e.g., circulars, package labels, container labels, etc.) and labeling 
changes for FDA review and approval. Labeling information is submitted 
to FDA for review in an application, supplement or, when appropriate, 
an annual report. Form FDA 2567 is approved under OMB control number 
0910-0338.
    Based on information obtained from CBER's database system, there is 
an estimated 350 manufacturers of licensed biological products. 
However, not all manufacturers will have any submissions in a given 
year and some may have multiple submissions. The total annual responses 
are based on the estimated number of submissions for a particular 
product (e.g., license applications and labeling supplements) received 
annually by FDA. No applications have been received for most of the 
listed products in the last couple of years, but FDA is using the 
estimate of one application in the event one is submitted in the 
future. Based on previous estimates, the rate of submissions is not 
expected to change significantly in the next few years.
    The hours per response is based on past FDA's experience with the 
various submissions to FDA and includes the time estimated to prepare 
the various submissions for FDA review and collate the documentation. 
The burden associated with the additional labeling requirements for 
submission in a license application is minimal because the majority of 
the burden is associated with the requirements under Sec. Sec.  610.60 
through 610.62 or other labeling requirements. FDA estimates that it 
takes between 10 to 40 hours (average 25 hours) to complete a labeling 
supplement or annual report for submission to FDA.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                                                       Annual
 21 CFR Section       Type of          No. of      Frequency per   Total Annual      Hours per      Total Hours
                     Submission      Respondents      Response       Responses       Response
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640.70(a) and     application                   5        1                     5               2              10
 640.74(b)(3)     supplement                   20        1.5                  30              25             750
 and (4)
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640.84(a) and     application                   1        1                     1               1               1
 (c)              supplement                    3        1.25                  4              25             100
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640.94(a)         application                   1        1                     1               1               1
                  supplement                    1        1                     1              25              25
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660.2(c)          application                   1        1                     1               3               3
                  supplement                    1        1                     1              25              25
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660.28(a) and     application                   1        1                     1               6               6
 (b)              supplement                    1        2                     2              25              50
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660.35(a)(c)      application                   1        1                     1               6               6
 through (a)(g)   supplement                    1        1                     1              25              25
 and 660.35
 (a)(i) through
 (a)(m)
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660.45            application                   1        1                     1               3               3
                  supplement                    1        1                     1              25              25
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660.55(a) and     application                   1        1                     1               6               6
 (b)              supplement                    1        1                     1              25              25
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Total                                                                                                      1,061
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.



[[Page 43361]]

    Dated: July 15, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-18503 Filed 7-21-03; 8:45 am]
BILLING CODE 4160-01-S