[Federal Register Volume 63, Number 169 (Tuesday, September 1, 1998)]
[Notices]
[Pages 46464-46465]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-23404]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97N-0385]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995 (the PRA).

DATES: Submit written comments on the collection of information by 
October 1, 1998.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Margaret R. Schlosburg, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.

SUPPLEMENTARY INFORMATION: In compliance with section 3507 of the PRA 
(44 U.S.C. 3507), FDA has submitted the following proposed collection 
of information to OMB for review and clearance.

Supplements to Premarket Approval Applications for Medical Devices

    The Food and Drug Administration Modernization Act of 1997 (FDAMA) 
(Pub. L. 105-115) added section 515(d)(6) to the Federal Food, Drug, 
and Cosmetic Act (the act) (21 U.S.C. 360e(d)(6)), modifying FDA's 
statutory authority regarding premarket approval of medical devices. 
This new section provides for an alternate form of notice to the agency 
for certain types of changes to a device for which the manufacturer has 
an approved premarket approval application (PMA). Under section 
515(d)(6) of the act, PMA supplements are required for all changes that 
affect safety and effectiveness, unless such changes involve 
modifications to manufacturing procedures or the method of manufacture. 
For those types of manufacturing changes, the manufacturer may submit 
to the agency an alternate form of notice in the form of a 30-day 
notice, or where FDA finds such notice inadequate, a 135-day PMA 
supplement. The 30-day notice must: (1) Describe the change the 
manufacturer intends to make, (2) summarize the data or information 
supporting the change, and (3) state that the change has been made in 
accordance with the requirements of 21 CFR part 820.
    The manufacturer may distribute the device 30 days after FDA 
receives the notice, unless FDA notifies the applicant, within that 30-
day period, that the notice is inadequate. If the notice is inadequate, 
FDA will inform the manufacturer that a 135-day supplement is required 
and will describe what additional information or action is necessary 
for FDA to approve the change. The rule would incorporate the 
provisions for a 30-day notice and 135-day supplements into FDA's 
regulations in Sec. 814.39 (21 CFR 814.39) to reflect the changes made 
by FDAMA.
     Description of Respondents: Businesses or other for profit 
organizations.
    The information collection for Sec. 814.39 has been approved by OMB 
until September 30, 1998, under Premarket Approval of Medical Devices 
(OMB control number 0910-0231) for a total of 36,063 hours. FDA 
believes that the submission of 30-day notices in lieu of PMA 
supplements will result in approximately a 10 percent reduction in the 
total number of hours needed to comply with Sec. 814.39. As a result, 
FDA estimates that the new total number of hours needed to comply with 
the information collection requirements in Sec. 814.39 is 32,612 for a 
reduction of 3,451 hours.
    FDA estimates the burden for this collection of information as 
follows:

                                  Table 1.--Estimated Annual Reporting Burden1                                  
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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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814.39                                493               1             493              66.15       32,612       
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of            
  information.                                                                                                  



[[Page 46465]]

    Dated: July 31, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-23404 Filed 8-31-98; 8:45 am]
BILLING CODE 4160-01-F