[Federal Register: September 25, 2000 (Volume 65, Number 186)]
[Notices]
[Page 57612-57614]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25se00-66]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 00N-1502]
Agency Information Collection Activities: Proposed Collection;
Comment Request; Adverse Experience Reporting for Licensed Biological
Products; and General Records
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 the information collection
requirements relating to FDA's adverse experience reporting (AER) for
licensed biological products, and general records associated with the
manufacture and distribution of biological products.
DATES: Submit written or electronic comments on the collection of
information by November 24, 2000.
ADDRESSES: Submit electronic comments on the collection of information
via the Internet at: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm. Submit written comments on the collection
of information to the Dockets Management Branch (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
All documents 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 request 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 extension 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 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.
Adverse Experience Reporting for Licensed Biological Products; and
General Records--21 CFR 600.12 and Part 600 Subpart D (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
which 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 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.
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 manufacturer 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
[[Page 57613]]
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.
Manufacturers of biological products for human use must keep
records of each step in the manufacture and distribution of products
including 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.
Respondents to this information collection are manufacturers of
biological products. In fiscal year (FY) 99 there were approximately 79
licensed manufacturers. 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.
However, not all manufacturers may have any submissions in a given year
and some may have multiple submissions. FDA received four waiver
requests under Sec. 600.90, of which one was approved for exemption of
the AER requirements. In FY 99, there were an estimated 3,662 15-day
alert reports, 13,238 periodic reports, and 502 distribution reports
submitted to FDA. The number of 15-day alert reports 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 hours per response are based
on FDA experience. 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 information collection
as follows:
Table 1.--Estimated Annual Reporting Burden1
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Annual
21 CFR section Number of frequency per Total annual Hours per Total hours
respondents response responses response
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600.80(c)(1) and (e) 78 46.95 3,662 1 3,662
600.80(c)(2) 78 169.72 13,238 1 13,238
600.81 78 6.44 502 1 502
600.90 4 1 4 1 4
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Total 17,407
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\1\There are no captital costs or operating and maintenance costs associated with this collection of
information.
There are approximately 343 licensed manufacturers of biological
products. However, the number of recordkeepers listed for
Sec. 600.12(a) through (e) excluding paragraph (b)(2) is estimated to
be 111. This number excludes manufacturers of blood and blood
components, because their burden hours for recordkeeping have been
reported under Sec. 606.160 in OMB Control No. 0910-0116. The
recordkeeping burden is based on the number of lots released (6,446),
the number of recalls made (1,176) and the total number of AER reports
received (16,900) for FY 99. The hours per record are based on FDA
experience.
FDA estimates the burden of this recordkeeping as follows:
Table 2.--Estimated Annual Recordkeeping Burden1
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Annual
21 CFR section Number of frequency of Total annual Hours per Total hours
recordkeepers recordkeeping records record
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600.12 111 58.1 6,446 32 206,272
600.12(b)(2) 343 3.4 1,176 24 28,224
600.80(i) 79 213.92 16,900 1 16,900
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Total 251,396
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 57614]]
Dated: September 19, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-24477 Filed 9-22-00; 8:45 am]
BILLING CODE 4160-01-F