[Federal Register Volume 63, Number 146 (Thursday, July 30, 1998)]
[Notices]
[Page 40719]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-20307]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 98D-0264, 98D-0265, et al.]
Food and Drug Administration Modernization Act of 1997;
Establishment of Public Dockets
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that it
is establishing a series of public dockets containing information on
the implementation of the Food and Drug Administration Modernization
Act of 1997 (Modernization Act). This action is intended to ensure that
information submitted to FDA on the implementation of the Modernization
Act is available to all interested persons in a timely fashion.
ADDRESSES: The public dockets are located in the Dockets Management
Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. The public dockets may be accessed directly
under the docket numbers provided in the list below, and they are also
posted on the agency's Internet World Wide Web (WWW) site at ``http://
www.fda.gov/ohrms/dockets''.
FOR FURTHER INFORMATION CONTACT:
Nancy E. Derr, Center for Drug Evaluation and Research (HFD-5),
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857,
301-594-5400;
Stephen M. Ripley, Center for Biologics Evaluation and Research
(HFM-17), Food and Drug Administration, 1401 Rockville Pike, Rockville,
MD 20852, 301-827-6210;
Joseph M. Sheehan, Center for Devices and Radiological Health (HFZ-
215), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD
20850, 301-827-2974; or
George A. Mitchell, Center for Veterinary Medicine (HFV-6), Food
and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-
827-5587.
SUPPLEMENTARY INFORMATION: On November 21, 1997, the President signed
the Modernization Act into law (Pub. L. 105-115). The Modernization Act
provides for the reauthorization of the Prescription Drug User Fee Act
of 1992, codifies many FDA initiatives undertaken in recent years under
the Administration's Reinventing Government Program, and implements
certain other reforms of FDA processes.
FDA has received numerous recommendations on how the agency should
implement various Modernization Act provisions for which dockets have
not yet been established. To provide timely public access to these
recommendations, FDA is establishing a series of public dockets through
which interested persons can have access to these recommendations and
other information submitted to FDA. Each docket contains information
pertaining to a specific section of the Modernization Act and may be
accessed directly under the docket numbers provided in the list below.
FDA expects to place submissions containing recommendations on how the
agency should implement the Modernization Act in one of these public
dockets, or in a new docket created for the specific provision
addressed in the recommendations. These dockets are in addition to
those already established in connection with implementation of other
provisions of the Modernization Act, i.e., dockets assigned to the
Modernization Act-related notices, guidances, or rules.
The following is a list of dockets that FDA is establishing at this
time to provide access to information submitted relating to the
implementation of specific provisions of the Modernization Act. The
list includes the section number of the Modernization Act, the title of
the docket, and the docket number.
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Section No. Docket Title Docket No.
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111 Pediatric Studies of Drugs 98D-0265
112 Fast Track Products 98D-0267
113 NIH Data Bank--Clinical Trials for Serious Diseases 98D-0293
114 Health Care Economic Information 98D-0468
118 Data Requirements for Drugs and Biologics 98D-0264
121 Positron Emission Tomography (PET) 98D-0266
122 Radiopharmaceuticals 98D-0372
127 Pharmacy Compounding 98D-0272
216 Six-Year Use of Data 98D-0466
406 Agency Plan for Statutory Compliance 98N-0339
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From time to time, FDA may establish dockets on other Modernization
Act provisions but does not intend to separately announce the creation
of such dockets. Instead, a list of the Modernization Act dockets will
be maintained on the agency's Internet WWW site at ``http//www.fda.gov/
ohrms/dockets''. The dockets created in connection with specific
notices, guidances, or rules published in the Federal Register are also
listed at this site.
The public dockets are available for public review in the Dockets
Management Branch (address above) between 9 a.m. and 4 p.m., Monday
through Friday.
Dated: July 22, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-20307 Filed 7-29-98; 8:45 am]
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