[Federal Register Volume 61, Number 210 (Tuesday, October 29, 1996)]
[Notices]
[Pages 55804-55805]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-27737]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 91N-0404]


Agency Information Collection; 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.

DATES: Submit written comments on the collections of information by 
November 29, 1996.
ADDRESSES: Submit written comments on the collections of information to 
the

[[Page 55805]]

Office of Information and Regulatory Affairs, OMB, New Executive Office 
Bldg., 725 17th St. NW., rm. 10235, Washington, DC, Attn: Desk Officer 
for FDA.

FOR FURTHER INFORMATION CONTACT: Charity B. Smith, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, rm. 16B-19, Rockville, MD 20857, 
301-827-1686.

SUPPLEMENTARY INFORMATION: In the Federal Register of June 26, 1996 (61 
FR 33232), FDA issued a final rule implementing the provisions of the 
Safe Medical Devices Act (the SMDA) regarding Humanitarian Use Devices 
(HUD's). The final rule contained information collection requirements 
subject to the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 
3507). In compliance with section 3507 of the PRA, FDA has submitted 
the following proposed collection of information to OMB for review and 
clearance:
     Title: Medical Devices; Humanitarian Use Devices.
    Description: This regulation implements the provision of the SMDA 
regarding HUD's. A HUD is exempt from the effectiveness requirements of 
sections 514 and 515 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360d and 360e). In order to implement this exemption, FDA is 
amending the premarket approval regulations in 21 CFR part 814 by 
creating new subpart H. This final regulation prescribes the procedures 
for submitting Humanitarian Device Exemption (HDE) applications, 
amendments and supplements; procedures for obtaining an extension of 
the exemption; and the criteria for FDA review and approval of HDE's. 
This final rule will create a needed incentive for the development of 
devices for use in the treatment or diagnosis of diseases or conditions 
affecting a small number of individuals.

                                   Table 1.--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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814.102                            20               1              20              40                 800       
814.104                            15               1              15             320               4,800       
814.106                            10               1              10             120               1,200       
814.108                            12               1              12              80                 960       
814.110(a)                          1               1               1              80                  80       
814.112(b)                          1               1               1               8                   8       
814.116(b)                         12               1              12               8                  96       
814.118(d)                          1               1               1               8                   8       
814.120(b)                         10               1              10             200               2,000       
814.124(b)                          2               1               2               2                   4       
814.126(b)(I)                       2               1               2             120                 240       
Total                                                                                              10,196       
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There are no capital costs or operating and maintenance costs associated with this collection.                  


                                 Table 2.--Estimated Annual Recordkeeping Burden                                
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                                                  Annual                                                        
       21 CFR Section             No. of       Frequency per   Total Annual      Hours per        Total Hours   
                               Recordkeepers   Recordkeeping      Records      Recordkeeper                     
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814.126(b)(ii)                     12               1              12               2                  24       
Total                                                                                                  24       
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There are no capital costs or operating and maintenance costs associated with this collection.                  


    Dated: October 24, 1996.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 96-27737 Filed 10-24-96; 3:21 pm]
BILLING CODE 4160-01-F