Agency Information Collection Activities: Proposed Collection; Comment Request, 45013-45014 [E8-17731]

Download as PDF 45013 Federal Register / Vol. 73, No. 149 / Friday, August 1, 2008 / Notices Services (CMS), and Bureau of the Census. Data collected through the NHDS are essential for evaluating health status of the population, for the planning of programs and policy to elevate the health status of the Nation, for studying morbidity trends, and for research activities in the health field. NHDS data have been used extensively in the development and monitoring of goals for the Year 2000 and 2010 Healthy People Objectives. In addition, NHDS data provide annual updates for numerous tables in the Congressionallymandated NCHS report, Health, United States. Other users of these data include universities, research organizations, foundations, and a variety of users in the print media. There is no cost to respondents other than their time to participate. The total estimated annualized burden hours are 5,591. TABLE 1—ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Type of data collection Current NHDS Primary Procedure Hospitals Sample Listing Sheet ........................................... Current NHDS Primary Procedure Hospitals Medical Abstract Form ......................................... Current NHDS Primary Procedure Hospitals Transmittal Notice ................................................ Current NHDS Alternate Procedure Hospitals locating medical records .................................... Current NHDS In-House Tape or Printout Hospital—computer programming and submission Current NHDS Hospital Interview Questionnaire ........................................................................ Redesigned pretest Survey presentation to hospital .................................................................. Redesigned pretest Facility questionnaire .................................................................................. Redesigned pretest Sample discharges within hospital, obtain UB–04 & payment data ........... Redesigned pretest Verify sampling & reabstract medical records ............................................ Redesign pretest Debrief hospital staff ....................................................................................... Redesigned 2010–2011 Survey presentation to hospital ........................................................... Redesigned 2010–2011 Facility questionnaire ........................................................................... Redesigned 2010–2011 Sample discharges within hospital, obtain UB–04 & payment data .... Redesigned 2010–2011 Verify sampling & re-abstract medical records .................................... Dated: July 24, 2008. Maryam I. Daneshvar, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E8–17605 Filed 7–31–08; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS–10265] Agency Information Collection Activities: Proposed Collection; Comment Request Centers for Medicare & Medicaid Services. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid Services (CMS) is publishing the following summary of proposed collections for public comment. Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency’s functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, mstockstill on PROD1PC66 with NOTICES AGENCY: VerDate Aug<31>2005 19:39 Jul 31, 2008 Jkt 214001 utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. 1. Type of Information Collection Request: New collection; Title of Information Collection: Mandatory Insurer Reporting Requirements of Section 111 of the Medicare, Medicaid and SCHIP Act of 2007 (MMSEA) (Pub. L. 110–173); Use: Section 111 of the Medicare, Medicaid and SCHIP Extension Act of 2007 (Pub. L. 110–173) amends the Medicare Secondary Payer (MSP) provisions of the Social Security Act (42 U.S.C. 1395y(b)) to provide for mandatory reporting by group health plan arrangements and by liability insurance (including self-insurance), nofault insurance, and workers’ compensation laws and plans. The law provides that, not withstanding any other provision of law, the Secretary of Health and Human Services may implement this provision by program instruction or otherwise. The Secretary has elected not to implement the provision through rulemaking and will implement by publishing instructions on a publicly available Web site and submitting an information collection request to OMB for review and approval of the associated information collection requirements. PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 13 13 13 41 29 10 10 10 10 2 10 80 80 160 3 Number of responses per respondent 12 250 12 250 12 1 1 1 10 10 1 1 1 120 25 Average burden per response (in hours) 25/60 5/60 1/60 1/60 13/60 2 1 4 14/60 14/60 1 1 4 14/60 14/60 Effective January 1, 2009, as required by the MMSEA, an entity serving as an insurer or third party administrator for a group health plan and, in the case of a group health plan that is self-insured and self-administered, a plan administrator or fiduciary must: (1) Secure from the plan sponsor and plan participants such information as the Secretary may specify to identify situations where the group health plan is a primary plan to Medicare; and (2) report such information to the Secretary in the form and manner (including frequency) specified by the Secretary. Effective July 1, 2009, as required by the MMSEA, ‘‘applicable plans,’’ must: (1) Determine whether a claimant is entitled to Medicare benefits; and, if so, (2) report the identity of such claimant and provide such other information as the Secretary may require to properly coordinate Medicare benefits with respect to such insurance arrangements in the form and manner (including frequency) as the Secretary may specify after the claim is resolved through a settlement, judgment, award or other payment (regardless of whether or not there is a determination or admission of liability). Applicable plan refers to the following laws, plans or other arrangements, including the fiduciary or administrator for such law, plan or arrangement: (1) Liability insurance (including self-insurance); (2) No-fault E:\FR\FM\01AUN1.SGM 01AUN1 45014 Federal Register / Vol. 73, No. 149 / Friday, August 1, 2008 / Notices mstockstill on PROD1PC66 with NOTICES insurance; and (3) Workers’ compensation laws or plans. As indicated, the Secretary has elected to implement this provision by publishing instructions at a Web site established for such purpose. The Web site is https://www.cms.hhs.gov/ MandatoryInsRep/. CMS shall use this Web site to publish preliminary guidance as well as the final instructions. The Web site also advises interested parties how to comment on the preliminary guidance. Form Number: CMS–10265 (OMB# 0938– New); Frequency: Yearly; Affected Public: Business or other for-profits, Not-for-profit institutions and State, Local or Tribal Governments; Number of Respondents: 290,404; Total Annual Responses: 6,920,504; Total Annual Hours: 2,120,478. To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access CMS’ Web Site at https://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 on (410) 786– 1326. In commenting on the proposed information collections please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in one of the following ways by September 30, 2008: 1. Electronically. You may submit your comments electronically to https:// www.regulations.gov. Follow the instructions for ‘‘Comment or Submission’’ or ‘‘More Search Options’’ to find the information collection document(s) accepting comments. 2. By regular mail. You may mail written comments to the following address: CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention: Document Identifier/OMB Control Number___, Room C4–26–05, 7500 Security Boulevard, Baltimore, Maryland 21244–1850. Dated: July 2, 2008. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. E8–17731 Filed 7–31–08; 8:45 am] BILLING CODE 4120–01–P VerDate Aug<31>2005 19:39 Jul 31, 2008 Jkt 214001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–N–0420] Medical Device User Fee Rates for Fiscal Year 2009 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is publishing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2009. The Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), the Medical Device User Fee Stabilization Act of 2005 (MDUFSA), and the Medical Device User Fee Amendments of 2007 (Title II of the Food and Drug Administration Amendments Act of 2007 (FDAAA)), authorizes FDA to collect user fees for certain medical device submissions, and annual fees both for certain periodic reports and for certain establishments subject to registration. The FY 2009 fee rates are provided in this notice. These fees apply from October 1, 2008, through September 30, 2009. To avoid delay in the review of your application, you should pay the fee before or at the time you submit your application to FDA. The fee you must pay is the fee that is in effect on the later of the date that your application is received by FDA or the date your fee payment is received. If you want to pay a reduced small business fee, you must qualify as a small business before you make your submission to FDA; if you do not qualify as a small business before you make your submission to FDA, you will have to pay the higher standard fee. This notice provides information on how the fees for FY 2009 were determined, the payment procedures you should follow, and how you may qualify for reduced small business fees. FOR FURTHER INFORMATION CONTACT: For information on MDUFMA: Visit FDA’s Web site, https://www.fda.gov/cdrh/ mdufma. For questions relating to this notice: David Miller, Office of Financial Management (HFA–100), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827–3917. SUPPLEMENTARY INFORMATION: I. Background Section 738 of the act (21 U.S.C. 379j) establishes fees for certain medical device applications, submissions, PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 supplements, and notices (for simplicity, this notice refers to these collectively as ‘‘submissions’’); for periodic reporting on class III devices; and for the registration of certain establishments. Under statutorilydefined conditions, a qualified applicant may receive a fee waiver or may pay a lower small business fee (see 21 U.S.C. 379j(d) and (e)). Under the act, the fee rate for each type of submission is set at a specified percentage of the standard fee for a premarket application (a premarket application is a premarket approval application (PMA), a product development protocol (PDP), or a biologics licensing application (BLA)). The act specifies the standard fee for a premarket application for each year from FY 2008 through FY 2012; the standard fee for a premarket application received by FDA during FY 2009 is $200,725. From this starting point, this notice establishes FY 2009 fee rates for other types of submissions, and for periodic reporting, by applying criteria specified in the act. The act specifies the annual fee for establishment registration for each year from FY 2008 through FY 2012; the registration fee for FY 2009 is $1,851. There is no reduction in the registration fee for small businesses. An establishment must pay the registration fee if it is any of the following types of establishments: • Manufacturer. An establishment that makes by any means any article that is a device, including an establishment that sterilizes or otherwise makes such article for or on behalf of a specification developer or any other person. • Single-Use Device Reprocessor. An establishment that performs manufacturing operations on a singleuse device that has previously been used on a patient. • Specification Developer. An establishment that develops specifications for a device that is distributed under the establishment’s name but which performs no manufacturing, including an establishment that, in addition to developing specifications, also arranges for the manufacturing of devices labeled with another establishment’s name by a contract manufacturer. The fees for FY 2009 go into effect on October 1, 2008, and will remain in effect through September 30, 2009. II. Fees for FY 2009 Under the act, all submission fees and the periodic reporting fee are set as a percent of the standard (full) fee for a premarket application (see 21 U.S.C. 379j(a)(2)(A)), and the act sets the E:\FR\FM\01AUN1.SGM 01AUN1

Agencies

[Federal Register Volume 73, Number 149 (Friday, August 1, 2008)]
[Notices]
[Pages 45013-45014]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-17731]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10265]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Centers for Medicare & Medicaid Services.

    In compliance with the requirement of section 3506(c)(2)(A) of the 
Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid 
Services (CMS) is publishing the following summary of proposed 
collections for public comment. Interested persons are invited to send 
comments regarding this burden estimate or any other aspect of this 
collection of information, including any of the following subjects: (1) 
The necessity and utility of the proposed information collection for 
the proper performance of the agency's functions; (2) the accuracy of 
the estimated burden; (3) ways to enhance the quality, utility, and 
clarity of the information to be collected; and (4) the use of 
automated collection techniques or other forms of information 
technology to minimize the information collection burden.
    1. Type of Information Collection Request: New collection; Title of 
Information Collection: Mandatory Insurer Reporting Requirements of 
Section 111 of the Medicare, Medicaid and SCHIP Act of 2007 (MMSEA) 
(Pub. L. 110-173); Use: Section 111 of the Medicare, Medicaid and SCHIP 
Extension Act of 2007 (Pub. L. 110-173) amends the Medicare Secondary 
Payer (MSP) provisions of the Social Security Act (42 U.S.C. 1395y(b)) 
to provide for mandatory reporting by group health plan arrangements 
and by liability insurance (including self-insurance), no-fault 
insurance, and workers' compensation laws and plans. The law provides 
that, not withstanding any other provision of law, the Secretary of 
Health and Human Services may implement this provision by program 
instruction or otherwise. The Secretary has elected not to implement 
the provision through rulemaking and will implement by publishing 
instructions on a publicly available Web site and submitting an 
information collection request to OMB for review and approval of the 
associated information collection requirements.
    Effective January 1, 2009, as required by the MMSEA, an entity 
serving as an insurer or third party administrator for a group health 
plan and, in the case of a group health plan that is self-insured and 
self-administered, a plan administrator or fiduciary must: (1) Secure 
from the plan sponsor and plan participants such information as the 
Secretary may specify to identify situations where the group health 
plan is a primary plan to Medicare; and (2) report such information to 
the Secretary in the form and manner (including frequency) specified by 
the Secretary.
    Effective July 1, 2009, as required by the MMSEA, ``applicable 
plans,'' must: (1) Determine whether a claimant is entitled to Medicare 
benefits; and, if so, (2) report the identity of such claimant and 
provide such other information as the Secretary may require to properly 
coordinate Medicare benefits with respect to such insurance 
arrangements in the form and manner (including frequency) as the 
Secretary may specify after the claim is resolved through a settlement, 
judgment, award or other payment (regardless of whether or not there is 
a determination or admission of liability). Applicable plan refers to 
the following laws, plans or other arrangements, including the 
fiduciary or administrator for such law, plan or arrangement: (1) 
Liability insurance (including self-insurance); (2) No-fault

[[Page 45014]]

insurance; and (3) Workers' compensation laws or plans.
    As indicated, the Secretary has elected to implement this provision 
by publishing instructions at a Web site established for such purpose. 
The Web site is https://www.cms.hhs.gov/MandatoryInsRep/. CMS shall use 
this Web site to publish preliminary guidance as well as the final 
instructions. The Web site also advises interested parties how to 
comment on the preliminary guidance. Form Number: CMS-10265 
(OMB 0938-New); Frequency: Yearly; Affected Public: Business 
or other for-profits, Not-for-profit institutions and State, Local or 
Tribal Governments; Number of Respondents: 290,404; Total Annual 
Responses: 6,920,504; Total Annual Hours: 2,120,478.
    To obtain copies of the supporting statement and any related forms 
for the proposed paperwork collections referenced above, access CMS' 
Web Site at https://www.cms.hhs.gov/PaperworkReductionActof1995, or e-
mail your request, including your address, phone number, OMB number, 
and CMS document identifier, to Paperwork@cms.hhs.gov, or call the 
Reports Clearance Office on (410) 786-1326.
    In commenting on the proposed information collections please 
reference the document identifier or OMB control number. To be assured 
consideration, comments and recommendations must be submitted in one of 
the following ways by September 30, 2008:
    1. Electronically. You may submit your comments electronically to 
https://www.regulations.gov. Follow the instructions for ``Comment or 
Submission'' or ``More Search Options'' to find the information 
collection document(s) accepting comments.
    2. By regular mail. You may mail written comments to the following 
address: CMS, Office of Strategic Operations and Regulatory Affairs, 
Division of Regulations Development, Attention: Document Identifier/OMB 
Control Number------, Room C4-26-05, 7500 Security Boulevard, 
Baltimore, Maryland 21244-1850.

    Dated: July 2, 2008.
Michelle Shortt,
Director, Regulations Development Group, Office of Strategic Operations 
and Regulatory Affairs.
[FR Doc. E8-17731 Filed 7-31-08; 8:45 am]
BILLING CODE 4120-01-P

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