Agency Information Collection Activities; Submission for Office of Management and Budget Review; Mammography Quality Standards Act Final Regulations; Modifications and Additions to Policy Guidance Help System #9, 77401-77402 [E5-8111]

Download as PDF wwhite on PROD1PC61 with NOTICES Federal Register / Vol. 70, No. 250 / Friday, December 30, 2005 / Notices serve as the basis for MHS performance guarantees. To meet these requirements, CMS has developed a performance monitoring system for MHS. This system includes measures of clinical performance that require the collection of clinical data from the medical records of a sample of Medicare beneficiaries. Medical record abstraction will be performed in two phases: The first, a pilot test, will take place after approximately six months of program operations, and the second, the full study. CMS will obtain active informed consent from the affected beneficiaries prior to reviewing medical records; Frequency: Reporting—Other: Only Once; Affected Public: Individuals or Households and Business or other forprofit; Number of Respondents: 26,643; Total Annual Responses: 26,643; Total Annual Hours: 12,416. 3. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Medicare— Determining Third Party Liability (TPL) State Plan Preprint and Supporting Regulations in 42 CFR 433.138; Form Number: CMS–R–0107 (OMB#: 0938– 0502); Use: Medicaid beneficiaries frequently have third party resources which are legally obligated to pay medical claims before Medicaid pays. Section 42 CFR 433.138 requires State Medicaid agencies to take specific steps to identify third party resources and determine their legal liability to pay for services under the plan. The collection of TPL information results in significant program savings to the extent that liable third parties can be identified and payments can be made for services that would otherwise be paid for by the Medicaid program. The State Medicaid agencies are the primary users of the collected data. Whenever States identify third party resources, pertinent information is entered into the State’s Medicaid Management Information System (MMIS). This enables the State to advise the provider to bill the third party and to seek reimbursement in situations where Medicaid TPL claims have been paid; Frequency: Recordkeeping—On occasion; Affected Public: Individuals or Households and Federal, State, Local and Tribal Government; Number of Respondents: 2,700,000; Total Annual Responses: 2,700,000; Total Annual Hours: 472,259. 4. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Request for Retirement Benefit Information (BBA ’97); Form Number: CMS–R–285 (OMB#: 0938–0769); Use: The Request for Retirement Benefit Information form VerDate Aug<31>2005 18:16 Dec 29, 2005 Jkt 208001 is used to obtain retirement benefit information from beneficiaries that purchase Medicare Part A coverage. The Social Security Administration (SSA) will use this information to determine if a beneficiary meets the requirements to qualify for a Medicare Part A premium reduction; Frequency: Reporting—On occasion; Affected Public: State, Local or Tribal Government; Number of Respondents: 1500; Total Annual Responses: 1500; Total Annual Hours: 375. To obtain copies of the supporting statement and any related forms for these paperwork collections referenced above, access CMS Web site address at http://www.cms.hhs.gov/ PaperworkReductionActof1995, or email your request, including your address, phone number, OMB number, and CMS document identifier, to Paperwork@cms.hhs.gov, or call the Reports Clearance Office at (410) 786– 1326. To be assured consideration, comments and recommendations for the proposed information collections must be received by the OMB Desk Officer at the address below, no later than 5 p.m. on January 30, 2006. OMB Human Resources and Housing Branch, Attention: Carolyn Lovett, CMS Desk Officer, New Executive Office Building, Room 10235, Washington, DC 20503. Dated: December 21, 2005. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 05–24567 Filed 12–29–05; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005N–0216] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Medical Devices; Humanitarian Use Devices AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Medical Devices; Humanitarian Use Devices’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 77401 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 24, 2005 (70 FR 61455), 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 0910–0332. 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. E5–8110 Filed 12–29–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005D–0195] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Mammography Quality Standards Act Final Regulations; Modifications and Additions to Policy Guidance Help System #9 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by January 30, 2006. ADDRESSES: The Office of Management and Budget (OMB) is still experiencing significant delays in the regular mail, including first class and express mail, and messenger deliveries are not being accepted. To ensure that comments on the information collection are received, OMB recommends that comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie E:\FR\FM\30DEN1.SGM 30DEN1 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]
[Pages 77401-77402]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E5-8111]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005D-0195]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Mammography Quality Standards Act 
Final Regulations; Modifications and Additions to Policy Guidance Help 
System 9

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

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

DATES: Fax written comments on the collection of information by January 
30, 2006.

ADDRESSES: The Office of Management and Budget (OMB) is still 
experiencing significant delays in the regular mail, including first 
class and express mail, and messenger deliveries are not being 
accepted. To ensure that comments on the information collection are 
received, OMB recommends that comments be faxed to the Office of 
Information and Regulatory Affairs, OMB, Attn: Fumie

[[Page 77402]]

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 (Sec.  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 (Sec.  
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 (Sec.  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 Burden\1\
----------------------------------------------------------------------------------------------------------------
                   Number of        Annual Frequency of      Total Annual          Hours per
  Activity        Respondents            Response              Responses            Response        Total Hours
----------------------------------------------------------------------------------------------------------------
Reporting                     915                     1                   915                0.5             458
 of refusal
 of lay
 summary
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


                               Table 2.--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
                   Number of       Annual Frequency per
  Activity       Recordkeepers            Record         Total Annual Records   Hours Per Record    Total hours
----------------------------------------------------------------------------------------------------------------
Documentati                    92                     1                    92                  8             736
 on of
 foreign-
 trained
 physicians
 '
 qualificat
 ions
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    There are a total of 9,150 MQSA-certified 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