Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Cosmetic Product Voluntary Reporting Program, 77402 [E5-8112]

Download as PDF 77402 Federal Register / Vol. 70, No. 250 / Friday, December 30, 2005 / Notices Yokota, Desk Officer for FDA, FAX: 202–395–6974. FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Management Programs (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827–1472. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Mammography Quality Standards Act Final Regulations; Modifications and Additions to Policy Guidance Help System #9 The Mammography Quality Standards Act (MQSA) Final Regulations: Modifications and Additions to Policy Guidance Help System 9 provides guidance to mammography facilities and their personnel on a variety of issues involving the quality standards for mammography (§ 900.12 (21 CFR 900.12)). Use of the guidance results in new collections of information. Facilities are required to provide patients with lay summaries of the results of their mammography examinations (§ 900.12(c)(2)). This guidance document provides information on how to address a patient’s refusal to receive a lay summary and recommends that the facility document why it was unable to meet this requirement. Additionally, the guidance addresses interpreting physician initial requirements (§ 900.12(a)(1)(i)(B)(2)), including recommendations on how to document the alternative to Board Certification for foreign-trained physicians. The likely respondents are mammography facilities and their personnel who are subject to the MQSA quality standards requirements. In the Federal Register of July 15, 2005 (70 FR 41043), FDA published a 60-day notice requesting comments on the information collection provisions. No comments were received. FDA estimates the burden of this collection of information as follows: TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 Activity Number of Respondents Annual Frequency of Response 915 1 Reporting of refusal of lay summary 1There Total Annual Responses Hours per Response 915 Total Hours 0.5 458 are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1 Activity Number of Recordkeepers Documentation of foreign-trained physicians’ qualifications 1There Total Annual Records Hours Per Record 1 92 8 92 Total hours 736 are no capital costs or operating and maintenance costs associated with this collection of information. There are a total of 9,150 MQSAcertified facilities. Using past experience, FDA estimates that 10 percent of these facilities will receive patient requests that lay summary results not be sent. We also estimate that the facility will spend 0.5 hours per patient obtaining the patient’s written request, filing that form in the patient’s record and forwarding the summary to the patient’s designee. With respect to foreign-trained physicians, past experience indicates that this situation arises very infrequently. We estimate that only 1 percent of MQSA-certified facilities will have to maintain records documenting the qualifications of foreign-trained physicians. Dated: December 22, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E5–8111 Filed 12–29–05; 8:45 am] BILLING CODE 4160–01–S wwhite on PROD1PC61 with NOTICES Annual Frequency per Record VerDate Aug<31>2005 18:16 Dec 29, 2005 Jkt 208001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005N–0217] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Cosmetic Product Voluntary Reporting Program AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Cosmetic Product Voluntary Reporting Program’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Management Programs (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827–4659. PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 In the Federal Register of October 11, 2005 (70 FR 59073), the agency announced that the proposed information collection had been submitted to OMB for review and clearance under 44 U.S.C. 3507. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910–0030. The approval expires on December 31, 2008. A copy of the supporting statement for this information collection is available on the Internet at http://www.fda.gov/ ohrms/dockets. SUPPLEMENTARY INFORMATION: Dated: December 22, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E5–8112 Filed 12–29–05; 8:45 am] BILLING CODE 4160–01–S E:\FR\FM\30DEN1.SGM 30DEN1

Agencies

[Federal Register Volume 70, Number 250 (Friday, December 30, 2005)]
[Notices]
[Page 77402]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E5-8112]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0217]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Cosmetic Product Voluntary Reporting 
Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
collection of information entitled ``Cosmetic Product Voluntary 
Reporting Program'' has been approved by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-4659.

SUPPLEMENTARY INFORMATION: In the Federal Register of October 11, 2005 
(70 FR 59073), the agency announced that the proposed information 
collection had been submitted to OMB for review and clearance under 44 
U.S.C. 3507. An agency may not conduct or sponsor, and a person is not 
required to respond to, a collection of information unless it displays 
a currently valid OMB control number. OMB has now approved the 
information collection and has assigned OMB control number 0910-0030. 
The approval expires on December 31, 2008. A copy of the supporting 
statement for this information collection is available on the Internet 
at http://www.fda.gov/ohrms/dockets.

    Dated: December 22, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E5-8112 Filed 12-29-05; 8:45 am]
BILLING CODE 4160-01-S