[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]
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