[Federal Register Volume 61, Number 244 (Wednesday, December 18, 1996)]
[Notices]
[Pages 66673-66675]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-32070]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96N-0393]
Agency Information Collection Activities: Proposed Collection;
Comment Request; Reinstatement
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,
Federal agencies are required to publish notice in the Federal Register
concerning each proposed collection of information, including each
proposed reinstatement of an existing collection of information, and to
allow 60 days for public comment in response to the notice. This notice
solicits comments on MEDWATCH medical product reporting program forms,
FDA form 3500 and 3500A.
DATES: Submit written comments on the collection of information by
February 18, 1997.
ADDRESSES: Submit written comments on the collection of information to
the Dockets Management Branch (HFA-305), Food and Drug Administration,
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. All comments should
be identified with the docket number found in brackets in the heading
of this document.
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FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Information
Resources Management (HFA-250), Food and Drug Administration, 5600
Fishers Lane, rm. 16B-19, Rockville, MD 20857, 301-827-1472.
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, including each proposed reinstatement 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 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.
MEDWATCH--FDA's Medical Products Reporting Program, Forms FDA 3500 and
FDA 3500A--21 CFR 310.305, 314.80, 600.80, 803.30, 803.50, 803.53,
803.56 (OMB Control Number 0910-0291--Reinstatement)
Under sections 505, 507, 512, 513, 515, and 903 of the Federal
Food, Drug, and Cosmetic Act (the act); (21 U.S.C. 355, 357, 360b,
360c, 360e, and 393) and section 351 of the Public Health Service Act
(42 U.S.C. 262), FDA has the responsibility to ensure the safety and
effectiveness of drugs, biologics, and devices. Under section 502(a) of
the act (21 U.S.C. 352(f)(2)), a drug or device is misbranded if its
labeling is false or misleading. Under section 502(f)(1) of the act it
is misbranded if it fails to bear adequate warnings, and under section
502(j), it is misbranded if it is dangerous to health when used as
directed in its labeling. To carry out its responsibilities, the agency
needs to be informed whenever an adverse event or product problem
occurs. Only if FDA is provided with such information, will the agency
be able to evaluate the risk, if any, associated with the product, and
take whatever action is necessary to reduce or eliminate the public's
exposure to the risk through regulatory action ranging from labeling
changes to the rare product withdrawal. To ensure the marketing of safe
and effective products, certain adverse events must be reported.
Requirements regarding mandatory reporting of adverse events or product
problems have been codified in 21 CFR 310.305, 314.80, 600.80, 803.30,
803.50, 803.53, and 803.56.
To implement these provisions for reporting of adverse events and
product problems with all medications, devices, and biologics, as well
as any other products that are regulated by FDA, two very similar forms
are used. These forms replaced all other forms used by the agency,
including Form FDA 1639. Form FDA 3500A is used for mandatory
reporting. Form FDA 3500 is used for voluntary (i.e., not mandated by
law or regulation) reporting of adverse events and product problems by
health professionals.
Respondents to this collection of information are health
professionals, hospitals, and other health care providers (i.e.,
nursing homes, etc.), manufacturers of biologics, drugs, and medical
devices, user facilities, distributors, and importers.
FDA estimates the burden of this collection of information as
follows:
Estimated Annual Reporting Burden
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Annual
21 CFR Section No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
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CBER:
600.80
Form 3500 993 1 993 0.5 496.5
Form 3500A 63 188.7 11,889 1.0 11,889
CDER:
310.305 and 314.80
Form 3500 19,922 1 19,922 0.5 9,961
Form 3500A 500 303.0 151,513 1.0 151,513
CDRH:
803.30, 803.50, 803.53, and
803.56
Form 3500 4,572 1 4,572 0.5 2,286
Form 3500A 39,889 2.8 110,933 1.0 110,933
CFSAN:
Form 3500 410 1 410 0.5 205
Form 3500A 0 0 0 0 0
Total Hours 287,283.5
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There are no capital costs or operating and maintenance costs associated with this collection.
(Note: Center for Biologics Evaluation and Research (CBER); Center for
Drug Evaluation and Research (CDER); Center for Devices and
Radiological Health (CDRH); and Center for Food Safety and Applied
Nutrition (CFSAN).
As more medical products are approved by FDA and marketed, and as
knowledge increases regarding the
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importance of notifying FDA when adverse events and product problems
are observed, it is expected that more reports will be submitted. The
figures shown in the table are based on previously calculated estimates
and actual 1995 reporting experiences. The number of reports recorded
above were annualized based on actual 1995 experience and an
anticipated 10-percent-per-year increase in reporting over the next 3
years. There are zeroes in the CFSAN row because mandatory reporting
using Form FDA 3500A is not required.
Dated: December 11, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-32070 Filed 12-17-96; 8:45 am]
BILLING CODE 4160-01-F