[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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.

                                                                                                                
----------------------------------------------------------------------------------------------------------------
      Section No.                             Docket Title                                  Docket No.          
----------------------------------------------------------------------------------------------------------------
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                      
----------------------------------------------------------------------------------------------------------------

    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]
BILLING CODE 4160-01-F