Agency Information Collection Activities: Proposed Collection; Comment Request, 38649-38650 [E6-10587]

Download as PDF Federal Register / Vol. 71, No. 130 / Friday, July 7, 2006 / Notices cprice-sewell on PROD1PC66 with NOTICES Affected Public: Business or other forprofit, Not-for-profit institutions, and the Federal Government. Number of Respondents: 108. Total Annual Responses: 108. Total Annual Hours: 4860. 2. Type of Information Collection Request: New Collection. Title of Information Collection: Medicare Part D Audit Guide, Version 1.0 and Supporting Regulation contained in 42 CFR Section 423.505. Use: 42 CFR 423.505 provides CMS the regulatory authority to audit, evaluate, or inspect any Part D sponsors’ performance related to the law in the areas of medication therapy management, drug utilization management, formulary, and grievances and appeals. The information collected will be an integral resource for oversight, monitoring, compliance, and auditing activities necessary to ensure quality provision of the Medicare Prescription Drug Benefit to beneficiaries. Form Number: CMS–10191 (OMB#: 0938–New). Frequency: Recordkeeping and Reporting—Annually. Affected Public: Business or other forprofit. Number of Respondents: 564. Total Annual Responses: 564. Total Annual Hours: 54,144. To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access CMS Web Site address 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. Written comments and recommendations for the proposed information collections must be mailed or faxed within 30 days of this notice directly to the OMB desk officer: OMB Human Resources and Housing Branch, Attention: Carolyn Lovett, New Executive Office Building, Room 10235, Washington, DC 20503, Fax Number: (202) 395–6974. Dated: June 28, 2006. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. E6–10586 Filed 7–6–06; 8:45 am] BILLING CODE 4120–01–P VerDate Aug<31>2005 15:46 Jul 06, 2006 Jkt 208001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS–R–136 and CMS–10198] Agency Information Collection Activities: Proposed Collection; Comment Request Centers for Medicare & Medicaid Services, HHS. 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: Extension of a currently approved collection. Title of Information Collection: Proper Claim Not Filed and Supporting Regulation in 42 CFR 411.32(c). Use: Section 411.32(c) requires physicians, providers, other suppliers, and beneficiaries, in case where they failed to submit a proper claim with a third party payer to report these situations on the current Medicare forms. The primary payer will notify the physician, provider, other supplier, or beneficiary of the amount normally payable, the amount of the reduction payable because the claim was not filed properly, and the amount the physician, provider, other supplier, or beneficiary is being paid under the ‘‘primary plan’’ due to the reduction. The information is transmitted on an explanation of benefits or remittance advice determination that third party payers provide to all covered individuals and physicians, providers and other suppliers as part of an industry practice. The information contained in this explanation, whether or not it concerns improperly filed claims, is submitted to Medicare as part of the claims process. AGENCY: PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 38649 Form Number: CMS–R–136 (OMB#: 0938–0564). Frequency: Reporting—On occasion. Affected Public: Business or other forprofit Not-for-profit institutions, and Individuals or Households. Number of Respondents: 1,129,000. Total Annual Responses: 1,129,000. Total Annual Hours: 1. 2. Type of Information Collection Request: New Collection. Title of Information Collection: Creditable Coverage Disclosure to CMS Instructions contained in 42 CFR 423.56. Use: Section 1860D–13 of the Medicare Modernization Act requires certain entities that provide prescription drug coverage to Medicare Part D eligible individuals to disclose to CMS whether such coverage meets the actuarial requirements specified in the guidelines provided by CMS. The actuarial determination measures whether the expected amount of paid claims under the entity’s prescription drug coverage is at least as much as the expected amount of paid claims under the standard Medicare prescription drug benefit. This information will be used for research, program evaluation and to verify whether or not beneficiaries are subject to a late enrollment penalty. Form Number: CMS–10198 (OMB#: 0938–New). Frequency: Recordkeeping, Third party disclosure and Reporting—On occasion and Annually. Affected Public: Business or other forprofit, Not-for-profit institutions and Federal, State, local or tribal government. Number of Respondents: 446,160. Total Annual Responses: 466,373. Total Annual Hours: 37,555. To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access CMS’ Web Site address 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. To be assured consideration, comments and recommendations for the proposed information collections must be received at the address below, no later than 5 p.m. on September 5, 2006. CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development—B, Attention: William N. Parham, III, Room C4–26– 05, 7500 Security Boulevard, Baltimore, Maryland 21244–1850. E:\FR\FM\07JYN1.SGM 07JYN1 38650 Federal Register / Vol. 71, No. 130 / Friday, July 7, 2006 / Notices Dated: June 28, 2006. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. E6–10587 Filed 7–6–06; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families cprice-sewell on PROD1PC66 with NOTICES Administration for Developmental Disabilities Award To: Oregon Health & Science University, Child Development & Rehabilitation Center. Purpose: To supplement a grant award for support of ‘‘Making It Real: Participatory Action Research (PAR) for University Centers for Excellence in Developmental Disabilities (UCEDDs)’’. Amount of Award: $65,000 for one year. Project Period: 7/1/2006—6/30/2007. Justification for Exception to Competition: After consulting with relevant, informed sources, including individuals with developmental disabilities and their families, the Administration for Developmental Disabilities (ADD) determined that it was beneficial to continue funding the Oregon Health & Science University, Child Development & Rehabilitation Center project to strengthen and expand the inclusion of people with developmental disabilities and their family members in participatory action research projects at University Centers for Excellence in Developmental Disabilities (UCEDDs). The Oregon Institute on Disability & Development, the Oregon Health and Science University, Child Development and Rehabilitation Center will receive a sole source program expansion supplemental grant for ‘‘Making It Real: Participatory Action Research (PAR) for UCEDDs,’’ a training initiative on the critical and emerging needs of individuals with developmental disabilities and their families. Through the project, a tool kit is being created that will include tested educational modules on participatory action research. Through the creation of the toolkit, every UCEDD will be able to access resources that will enhance and increase PAR and support initiatives that are most meaningful to people with developmental disabilities and their families. It will also be available to individuals with developmental disabilities, family members, advocacy groups, and other interested VerDate Aug<31>2005 15:46 Jul 06, 2006 Jkt 208001 organizations. By continuing funding of this project, additional resources will be developed, including materials in Spanish. In addition, the expansion supplement will allow for more time and resources to enhance training and dissemination efforts. The Administration for Children and Families intends to supplement the current grant by $65,000. The grantee will continue to provide a 25 percent match. FOR FURTHER INFORMATION CONTACT: Jennifer G. Johnson, Ed.D., Program Specialist, Administration on Developmental Disabilities, 200 Independence Avenue, SW., Room 405– D, Washington, DC 20201. Telephone: 202/690–5982 (v); 202/205–8037 (f). Email: jennifer.johnson@acf.hhs.gov. Dated: June 21, 2006. Patricia A. Morrissey, Commissioner, Administration for Developmental Disabilities. [FR Doc. E6–10578 Filed 7–6–06; 8:45 am] BILLING CODE 4184–01–P was signed into law on October 22, 1994. AMDUCA allows veterinarians to prescribe extralabel uses of approved animal drugs and approved human drugs for animals under certain conditions. An extralabel use must be by or on the order of a licensed veterinarian within the context of a veterinarian-client-patient relationship and must be in conformance with the implementing regulations published in part 530 (21 CFR part 530). A list of drugs specifically prohibited from extralabel use in animals is in § 530.41. With the enactment of AMDUCA and the issuance of implementing regulations, FDA is withdrawing CPG 7125.35 because it is obsolete. On September 24, 1998, a CPG section 615.100 entitled ‘‘Extralabel Use of New Animal Drugs in Food-Producing Animals (CPG 7125.06)’’ was withdrawn for the same reason (63 FR 51074). Dated: June 20, 2006. Margaret O’K. Glavin, Associate Commissioner for Regulatory Affairs. [FR Doc. E6–10672 Filed 7–6–06; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES BILLING CODE 4160–01–S Food and Drug Administration DEPARTMENT OF HEALTH AND HUMAN SERVICES [Docket No. 1990D–0428] Human-Labeled Drugs Distributed and Used in Animal Medicine; Withdrawal of Compliance Policy Guide AGENCY: Food and Drug Administration, HHS. ACTION: Notice; withdrawal. PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 [Docket No. 2006D–0214] Streptomycin Residues in Cattle Tissues; Withdrawal of Compliance Policy Guide AGENCY: The Food and Drug Administration (FDA) is announcing the withdrawal of a compliance policy guide (CPG) that was issued on March 19, 1991. DATES: July 7, 2006. FOR FURTHER INFORMATION CONTACT: Diane D. Jeang, Division of Compliance Policy (HFC–230), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 240–632–6833. SUPPLEMENTARY INFORMATION: In a notice published in the Federal Register of July 30, 1992 (57 FR 33729), FDA announced the availability of a revised CPG 7125.35 entitled ‘‘Human-Labeled Drugs Distributed and Used in Animal Medicine.’’ The CPG is being withdrawn because it is obsolete. This CPG explained how FDA would exercise its enforcement discretion with respect to the distribution and use of humanlabeled drug products for use in animals. The Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA) SUMMARY: Food and Drug Administration Food and Drug Administration, HHS. ACTION: Notice; withdrawal. SUMMARY: The Food and Drug Administration (FDA) is announcing the withdrawal of the compliance policy guide (CPG) entitled ‘‘Sec. 616.100 Streptomycin Residues in Cattle Tissues (CPG 7125.22).’’ This CPG is obsolete. DATES: The withdrawal is effective July 7, 2006. FOR FURTHER INFORMATION CONTACT: Diane D. Jeang, Division ofCompliance Policy (HFC–230), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 240–632–6833. SUPPLEMENTARY INFORMATION: FDA issued the CGP entitled ‘‘Sec. 616.100 Streptomycin Residues in Cattle Tissues (CPG 7125.22)’’ on October 1, 1980. The CPG was issued because there were no published tolerances for residues of streptomycin in cattle tissue and the available data supported an action level of 2 part per million (ppm) streptomycin/dihydrostreptomycin E:\FR\FM\07JYN1.SGM 07JYN1

Agencies

[Federal Register Volume 71, Number 130 (Friday, July 7, 2006)]
[Notices]
[Pages 38649-38650]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-10587]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-R-136 and CMS-10198]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Centers for Medicare & Medicaid Services, HHS.
    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: Extension of a currently 
approved collection.
    Title of Information Collection: Proper Claim Not Filed and 
Supporting Regulation in 42 CFR 411.32(c).
    Use: Section 411.32(c) requires physicians, providers, other 
suppliers, and beneficiaries, in case where they failed to submit a 
proper claim with a third party payer to report these situations on the 
current Medicare forms. The primary payer will notify the physician, 
provider, other supplier, or beneficiary of the amount normally 
payable, the amount of the reduction payable because the claim was not 
filed properly, and the amount the physician, provider, other supplier, 
or beneficiary is being paid under the ``primary plan'' due to the 
reduction. The information is transmitted on an explanation of benefits 
or remittance advice determination that third party payers provide to 
all covered individuals and physicians, providers and other suppliers 
as part of an industry practice. The information contained in this 
explanation, whether or not it concerns improperly filed claims, is 
submitted to Medicare as part of the claims process.
    Form Number: CMS-R-136 (OMB: 0938-0564).
    Frequency: Reporting--On occasion.
    Affected Public: Business or other for-profit Not-for-profit 
institutions, and Individuals or Households.
    Number of Respondents: 1,129,000.
    Total Annual Responses: 1,129,000.
    Total Annual Hours: 1.
    2. Type of Information Collection Request: New Collection.
    Title of Information Collection: Creditable Coverage Disclosure to 
CMS Instructions contained in 42 CFR 423.56.
    Use: Section 1860D-13 of the Medicare Modernization Act requires 
certain entities that provide prescription drug coverage to Medicare 
Part D eligible individuals to disclose to CMS whether such coverage 
meets the actuarial requirements specified in the guidelines provided 
by CMS. The actuarial determination measures whether the expected 
amount of paid claims under the entity's prescription drug coverage is 
at least as much as the expected amount of paid claims under the 
standard Medicare prescription drug benefit. This information will be 
used for research, program evaluation and to verify whether or not 
beneficiaries are subject to a late enrollment penalty.
    Form Number: CMS-10198 (OMB: 0938-New).
    Frequency: Recordkeeping, Third party disclosure and Reporting--On 
occasion and Annually.
    Affected Public: Business or other for-profit, Not-for-profit 
institutions and Federal, State, local or tribal government.
    Number of Respondents: 446,160.
    Total Annual Responses: 466,373.
    Total Annual Hours: 37,555.
    To obtain copies of the supporting statement and any related forms 
for the proposed paperwork collections referenced above, access CMS' 
Web Site address 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.
    To be assured consideration, comments and recommendations for the 
proposed information collections must be received at the address below, 
no later than 5 p.m. on September 5, 2006. CMS, Office of Strategic 
Operations and Regulatory Affairs, Division of Regulations 
Development--B, Attention: William N. Parham, III, Room C4-26-05, 7500 
Security Boulevard, Baltimore, Maryland 21244-1850.


[[Page 38650]]


    Dated: June 28, 2006.
Michelle Shortt,
Director, Regulations Development Group, Office of Strategic Operations 
and Regulatory Affairs.
 [FR Doc. E6-10587 Filed 7-6-06; 8:45 am]
BILLING CODE 4120-01-P

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.