[Federal Register: October 31, 2003 (Volume 68, Number 211)]
[Notices]               
[Page 62084-62086]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31oc03-66]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003N-0302]

 
Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995 (the PRA).

[[Page 62085]]


DATES: Fax written comments on the collection of information by 
December 1, 2003.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. To ensure that comments on the information 
collection are received, OMB recommends that written comments be faxed 
to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie 
Yokota, Desk Officer for FDA, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: JonnaLynn P. Capezzuto, Office of 
Management Programs (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.

Certain Biologics Labeling

    Under the authority of section 351 of the Public Health Services 
Act (42 U.S.C. 262), the biologics regulations in part 601 (21 CFR part 
601) 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 (Sec.  601.2). In addition, Sec.  601.12 requires that any 
changes to labeling be submitted to FDA for review and approval. For 
biological products, excluding blood and blood components for 
transfusion, the container and package labeling requirements subject to 
the PRA are provided in Sec. Sec.  610.60 through 610.62 (21 CFR 610.60 
through 610.62). The collections of information under Sec. Sec.  601.2, 
601.12, and 610.60 through 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., 21 CFR 809.10), there are additional 
container and/or package labeling requirements for certain licensed 
biological products subject to the PRA:
    [sbull] Sections 640.70 and 640.74 (21 CFR 640.70 and 640.74) 
(source plasma),
    [sbull] Section 640.84 (albumin),
    [sbull] Section 640.94 (plasma protein fraction),
    [sbull] Section 660.2 (21 CFR 660.2) (antibody to Hepatitis B 
surface antigen),
    [sbull] Section 660.28 (blood grouping reagent),
    [sbull] Section 660.35 (reagent red blood cells),
    [sbull] Section 660.45 (Hepatitis B surface antigen), and
    [sbull] Section 660.55 (anti-human globulin).
    An example of an additional labeling requirement for each of the 
specific regulations follows:
    [sbull] Section 640.70(a), the total volume or weight of plasma;
    [sbull] Section 640.74(b)(3) and (b)(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); and
    [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 the Center for Biologics 
Evaluation and Research's database system, there are 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 that 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 are based on FDA's past 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 and 40 hours (average 25 hours) to complete a labeling 
supplement or annual report for submission to FDA.
    In the Federal Register of July 22, 2003 (68 FR 43359), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                                           No. of       Annual Frequency   Total Annual      Hours per
                21 CFR Part                    Type of  Submission       Respondents      per Response       Responses       Response       Total Hours
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640.70(a), and 640.74(b)(3) and (b)(4)      application                             5               1                  5               2              10
                                           -------------------------------------------------------------------------------------------------------------
                                            supplement                             20               1.5               30              25             750
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640.84(a) and (c)                           application                             1               1                  1               1               1
                                           -------------------------------------------------------------------------------------------------------------
                                            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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[[Page 62086]]


660.2(c)                                    application                             1               1                  1               3               3
                                           -------------------------------------------------------------------------------------------------------------
                                            supplement                              1               1                  1              25              25
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660.28(a) and (b)                           application                             1               1                  1               6               6
                                           -------------------------------------------------------------------------------------------------------------
                                            supplement                              1               2                  2              25              50
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660.35(a), (c) through (g), and (i)         application                             1               1                  1               6               6
 through (m)
                                           -------------------------------------------------------------------------------------------------------------
                                            supplement                              1               1                  1              25              25
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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 (b)                           application                             1               1                  1               6               6
                                           -------------------------------------------------------------------------------------------------------------
                                            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.


    Dated: October 24, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-27389 Filed 10-30-03; 8:45 am]

BILLING CODE 4160-01-S