[Federal Register Volume 62, Number 180 (Wednesday, September 17, 1997)]
[Notices]
[Pages 48870-48871]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-24581]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97N-0022]
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 17, 1997.
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,
Attention: Desk Officer for FDA.
FOR FURTHER INFORMATION CONTACT: Judith V. Bigelow, Office of
Information
[[Page 48871]]
Resources Management (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-1479.
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:
Notice of Availability of Sample Electronic Product--21 CFR Parts
1020, 1030, 1040, and 1050 and FDA Form 2767 (OMB Control No. 0910-
0048--Reinstatement)
Under sections 532 through 542 of the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C. 360ii through 360ss), FDA regulates
electronic products that emit radiation. Section 532 of the act directs
the Secretary of the Department of Health and Human Services (the
Secretary) to establish and carry out an electronic product radiation
control program designed to protect the public health and safety from
electronic radiation, and authorizes the Secretary to procure (by
negotiation or otherwise) electronic products for research and testing
purposes and to sell or otherwise dispose of such products.
FDA's Center for Devices and Radiological Health (CDRH) conducts
laboratory compliance testing of products covered by regulations for
product standards in parts 1020, 1030, 1040, and 1050 (21 CFR parts
1020, 1030, 1040, and 1050). The ``Notice of Availability of Sample
Electronic Product'' (Form FDA 2767) is used to inform CDRH of the
location of sample products that are being requested for testing to
confirm that the products comply with performance standards. Form FDA
2767 is a summary form which reports information as required by parts
1020, 1030, 1040, and 1050.
FDA also uses this information to locate and select sample
products to ensure conformance with regulations. In the event this
information were not collected by CDRH, each manufacturer would have to
respond in letter format with all the data now being recorded on Form
FDA 2767, which would require more time and expense. Testing an
appropriate percentage of these products to protect the public would
also be hindered by the slower process.
The respondents to this collection of information are
manufacturers of electronic products.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden
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Annual
21 CFR Part and Form Number No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
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1020, 1030, 1040, 1050, and Form
FDA 2767 145 11.03 1,600 0.09 144
Totals 144
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There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA's estimates are based on actual data collected from industry
over the past 3 years, where there has been an average of 1,600 annual
responses to FDA from 145 respondents each year.
Dated: September 9, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-24581 Filed 9-16-97; 8:45 am]
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