[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
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supplement 20 1.5 30 25 750
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640.84(a) and (c) application 1 1 1 1 1
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supplement 3 1.25 4 25 100
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640.94(a) application 1 1 1 1 1
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supplement 1 1 1 25 25
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[[Page 62086]]
660.2(c) application 1 1 1 3 3
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supplement 1 1 1 25 25
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660.28(a) and (b) application 1 1 1 6 6
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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)
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supplement 1 1 1 25 25
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660.45 application 1 1 1 3 3
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supplement 1 1 1 25 25
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660.55(a) and (b) application 1 1 1 6 6
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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