[Federal Register Volume 63, Number 132 (Friday, July 10, 1998)]
[Notices]
[Pages 37394-37396]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-18402]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98N-0482]
Agency Information Collection Activities: Proposed Collection;
Comment Request
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,
including each proposed extension 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 of FDA's adverse experience
reporting (AER) for licensed biological products and general records.
DATES: Submit written comments on the collections of information by
September 8, 1998.
ADDRESSES: Submit written comments on the collections of information to
the Dockets Management Branch (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 P. Capezzuto, Office of
Information Resources Management (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 collections
of information listed below.
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.
Adverse Experience Reporting for Licensed Biological Products--21
CFR 600.80, 600.81, and 600.90; and General Records--21 CFR 600.12
(OMB Control Number 0910-0308)--Extension
Under the Public Health Service Act (42 U.S.C. 262), FDA is
required to ensure the marketing of only those biological products that
are safe and effective. FDA must therefore be informed of all adverse
experiences occasioned by the use of licensed biological products. FDA
issued the adverse experience reporting requirements to enable FDA to
take actions necessary for the protection of the public health in
response to reports of adverse experiences related to licensed
biological products. The primary purpose of FDA's adverse experience
reporting system is to flag potentially serious safety problems with
licensed biological products, focusing especially on newly licensed
products. Although premarket testing discloses a general safety profile
of a new drug's comparatively common adverse effects, the larger and
more diverse patient populations exposed to the licensed biological
product provides the opportunity to collect information on rare,
latent, and long-term effects. Reports are obtained from a variety of
sources, including patients, physicians, foreign regulatory agencies,
and clinical investigators. Information derived from
[[Page 37395]]
the adverse experience reporting system contributes directly to
increased public health protection because such information enables FDA
to recommend important changes to the product's labeling (such as
adding a new warning), to initiate removal of a biological product from
the market when necessary, and to assure the manufacturer has taken
adequate corrective action if necessary.
Manufacturers of biological products for human use must also keep
records of each step in the manufacture and distribution of products
including any recalls of the product. The recordkeeping requirements
serve preventative and remedial purposes. These requirements establish
accountability and traceability in the manufacture and distribution of
products, and enable FDA to perform meaningful inspections.
Section 600.12 (21 CFR 600.12) requires that all records of each
step in the manufacture and distribution of a product be made and
retained for no less than 5 years after the records of manufacture have
been completed or 6 months after the latest expiration date for the
individual product, whichever represents a later date. In addition,
records of sterilization of equipment and supplies, animal necropsy
records, and records in cases of divided manufacturing of a product are
required to be maintained. Section 600.12(b)(2) requires complete
records to be maintained pertaining to the recall from distribution of
any product.
Section 600.80(c)(1) (21 CFR 600.80(c)(1)) requires the licensed
manufacturer to report each adverse experience that is both serious and
unexpected, regardless of source, as soon as possible but in any case
within 15 working days of initial receipt of the information. Section
600.80(e) requires licensed manufacturers to submit a 15-day alert
report obtained from a postmarketing clinical study only if there is a
reasonable possibility that the product caused the adverse experience.
Section 600.80(c)(2) requires the licensed manufacturer to report each
adverse experience not reported under paragraph (c)(1) at quarterly
intervals, for 3 years from the date of issuance of the product
license, and then at annual intervals. The majority of the periodic
reports will be submitted annually since a large percentage of the
current licensed biological products have been licensed longer than 3
years. Section 600.80(i) requires the licensed manufacturers to
maintain for a period of 10 years records of all adverse experiences
known to the licensed manufacturer, including raw data and any
correspondence relating to the adverse experiences. Section 600.81 (21
CFR 600.81) requires the licensed manufacturer to submit information
about the quantity of the product distributed under the product
license, including the quantity distributed to distributors at an
interval of every 6 months. The semiannual distribution report informs
FDA of the quantity, the lot number, and the dosage of different
products. Section 600.90 (21 CFR 600.90) requires a licensed
manufacturer to submit a waiver request with supporting documentation
when asking for waiving the requirement that applies to them under
Secs. 600.80 and 600.81.
Respondents to this collection of information are manufacturers of
biological products. In fiscal year (FY) 1996, there were approximately
72 licensed manufacturers, 3 of which submitted waiver requests under
Sec. 600.90 and were exempt from these AER requirements. This number
excludes those manufacturers who produce blood and blood components and
in vitro diagnostic licensed products because they are specifically
exempt from the regulations. In FY 1996, there were 1,616 15-day alert
reports, 5,903 periodic reports and 464 distribution reports submitted
to FDA. The number of 15-day alert report for postmarketing studies as
stated in Sec. 600.80(e) was minimal and is included in the total
number of 15-day alert reports. The burden hours required to complete
the MedWatch Form for Sec. 600.80(c)(1), (e), and (f) are reported
under OMB Control No. 0910-0291. FDA estimates the burden of this
collection of information as follows:
Table 1.--Estimated Annual Reporting Burden1
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Number of
21 CFR Section No. of Responses per Total Annual Hours per Total Hours
Respondents Respondent Responses Response
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600.80(c)(1) and 600.80(e) 69 23.4 1,616 1 1,616
600.80(c)(2) 69 85.6 5,903 1 5,903
600.81 69 6.7 464 1 464
600.90 3 1 3 1 3
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
There are approximately 391 licensed manufacturers of biological
products. However, the number of recordkeepers listed for
Sec. 600.12(a) through (e) excluding (b)(2) is estimated to be 102.
This number excludes manufacturers of blood and blood components
because their burden hours for recordkeeping have been reported under
21 CFR 606.160 in OMB Control No. 0910-0116. The recordkeeping burden
is based on the number of lots released (9,027), the number of recalls
made (710) and the total number of AER reports received (7,519) for FY
1996. FDA estimates that the average time associated with recordkeeping
per lot is 32 hours, for recalls is 24 hours, and for adverse
experience reports is 1 hour. FDA estimates the burden of this
recordkeeping as follows:
Table 2.--Estimated Annual Recordkeeping Burden1
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Annual
21 CFR Section No. of Frequency per Total Annual Hours per Total Hours
Recordkeepers Recordkeeping Records Recordkeeper
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600.12 102 88.5 9,027 2,832 288,864
600.12(b)(2) 391 1.8 710 43 16,813
600.80(i) 69 109 7,519 109 7,519
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 37396]]
Dated: June 29, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-18402 Filed 7-9-98; 8:45 am]
BILLING CODE 4160-01-F
