Agency Information Collection Activities: Proposed Collection: Comment Request, 41028-41029 [E6-11440]

Download as PDF 41028 Federal Register / Vol. 71, No. 138 / Wednesday, July 19, 2006 / Notices orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before September 13, 2006. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before September 13, 2006. Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Victoria Ferretti-Aceto at least 7 days in advance of the meeting. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: July 13, 2006. Randall W. Lutter, Associate Commissioner for Policy and Planning. [FR Doc. E6–11471 Filed 7–18–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Comment Request In compliance with the requirement for opportunity for public comment on proposed data collection projects (section 3506(c)(2)(A) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Pub. L. 104–13), the Health Resources and Services Administration (HRSA) publishes periodic summaries of proposed projects being developed for submission to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, call the HRSA Reports Clearance Officer on (301) 443–1129. Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Proposed Project: Drug Pricing Program Reporting Requirements (OMB No. 0915–0176)—Extension Section 602 of Public Law 102–585, the Veterans Health Care Act of 1992, enacted section 340B of the Public Health Service Act (PHS Act) ‘‘Limitation on Prices of Drugs Purchased by Covered Entities.’’ Section 340B provides that a manufacturer who sells covered outpatient drugs to eligible entities must sign a pharmaceutical pricing agreement with the Secretary of Health and Human Services in which the manufacturer agrees to charge a price for covered outpatient drugs that will not exceed an amount determined under a statutory formula. Covered entities which choose to participate in the section 340B drug discount program must comply with the requirements of 340B(a)(5) of the PHS Act. Section 340B(a)(5)(A) prohibits a covered entity from accepting a discount for a drug that would also generate a Medicaid rebate. Further, section 340B(a)(5)(B) prohibits a covered entity from reselling or otherwise transferring a discounted drug to a person who is not a patient of the entity. In response to the statutory mandate of section 340B(a)(5)(C) to develop audit guidelines and because of the potential sroberts on PROD1PC70 with NOTICES Responses per respondent Number of respondents Reporting requirement for disputes involving covered entities and participating drug manufacturers, the HRSA Office of Pharmacy Affairs (OPA) has developed a dispute resolution process for manufacturers and covered entities as well as manufacturer guidelines for audit of covered entities. Audit Guidelines: A manufacturer will be permitted to conduct an audit only when there is reasonable cause to believe a violation of section 340B(a)(5)(A) or (B) has occurred. The manufacturer must notify the covered entity in writing when it believes the covered entity has violated the provisions of 340B. If the problem cannot be resolved, the manufacturer must then submit an audit work plan describing the audit and evidence in support of the reasonable cause standard to the HRSA OPA for review. The office will review the documentation to determine if reasonable cause exists. Once the audit is completed, the manufacturer will submit copies of the audit report to the HRSA OPA for review and resolution of the findings, as appropriate. The manufacturer will also submit an informational copy of the audit report to the HHS Office of Inspector General. Dispute Resolution Guidelines: Because of the potential for disputes involving covered entities and participating drug manufacturers, the HRSA OPA has developed an informal dispute resolution process which can be used if an entity or manufacturer is believed to be in violation of section 340B. Prior to filing a request for resolution of a dispute with the HRSA OPA, the parties must attempt, in good faith, to resolve the dispute. All parties involved in the dispute must maintain written documentation as evidence of a good faith attempt to resolve the dispute. If the dispute is not resolved and dispute resolution is desired, a party must submit a written request for a review of the dispute to the HRSA OPA. A committee appointed to review the documentation will send a letter to the party alleged to have committed a violation. The party will be asked to provide a response to or a rebuttal of the allegations. The estimates of annualized burden are as follows: Total responses Hours per response Total burden hours Audits Audit Notification of Entity* .................................................. Audit Work Plan ................................................................... VerDate Aug<31>2005 18:28 Jul 18, 2006 Jkt 208001 PO 00000 Frm 00046 2 1 Fmt 4703 Sfmt 4703 1 1 E:\FR\FM\19JYN1.SGM 2 1 19JYN1 4 8 8 8 41029 Federal Register / Vol. 71, No. 138 / Wednesday, July 19, 2006 / Notices Responses per respondent Number of respondents Reporting requirement Audit Report ......................................................................... Entity Response ................................................................... 1 0 Total responses Hours per response Total burden hours 1 0 1 0 1 0 1 0 Dispute Resolution Mediation Request ............................................................... Rebuttal ................................................................................ 2 2 4 1 8 2 10 16 80 32 Total Reporting ............................................................. 8 ........................ 14 ........................ 129 Recordkeeping Requirement Dispute Records .................................................................. 10 1 10 .5 5 Total Recordkeeping ..................................................... 10 ........................ ........................ ........................ 5 *Prepared by the manufacturer. Send comments to Susan G. Queen, Ph.D., HRSA Reports Clearance Officer, Room 10–33, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857. Written comments should be received within 60 days of this notice. Dated: July 12, 2006. Cheryl R. Dammons, Director, Division of Policy Review and Coordination. [FR Doc. E6–11440 Filed 7–18–06; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; Comment Request; Survey of Estimated Glomerular Filtration Rate Reporting Practices of Clinical Laboratories SUMMARY: Under the provisions of section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on January 25, 2006, page 4151–4152 and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. This 30-day submission is modified in order to reflect an increase in sample size. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Proposed Collection Title: A Survey of Estimated GFR Reporting Practices of Clinical Laboratories. Type of Information Collection Request: New. Need and Use of Information Collection: This study will assess the level of U.S. clinical laboratory reporting of estimated GFR as a measure of kidney function through a baseline survey of a representative sample of clinical laboratories in the U.S. Results will later serve as comparison to measure an anticipated increase in use of estimated GFR, following implementation of the National Kidney Disease Education Program’s communications and Lab Working Group (LWG) activities promoting use of estimated GFR for patients at risk for kidney disease. The LWG, whose members are experts in their field, sroberts on PROD1PC70 with NOTICES Note: Completing this survey is similar to other data reporting carried out by lab directors. Since lab directors will be able to respond to the survey within their usual workday, this collection of information will not cost labs/employers additional time and money. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. Estimated number of responses per respondent Estimated number of respondents Type of respondents strongly believes that routine reporting of estimated GFR will result in a significant increase in early detection of chronic kidney disease, therefore enabling treatment that can slow or prevent patients’ progression to kidney failure. Frequency of Response: Baseline survey only. Affected Public: Clinical laboratory community. Type of Respondents: Laboratory directors. The annual reporting burden is as follows: Estimated Number of Respondents: Anticipate 5,085 completed surveys; Estimated Number of Responses per Respondent: Respondents will complete one paper-and-pencil or Web-based survey; Average Burden Hours Per Response: .083 hours [5 minutes]; and Estimated Total Annual Burden Hours Requested: 422.06 hours. The annualized total cost to respondents is estimated at $14,408.96. Average burden hours per response Annual total burden hours requested Clinical Laboratory Directors ........................................................... 5,085 1.0 .083 422.06 Total .......................................................................................... 5,085 1.0 .083 422.06 VerDate Aug<31>2005 18:28 Jul 18, 2006 Jkt 208001 PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 E:\FR\FM\19JYN1.SGM 19JYN1

Agencies

[Federal Register Volume 71, Number 138 (Wednesday, July 19, 2006)]
[Notices]
[Pages 41028-41029]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-11440]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities: Proposed Collection: 
Comment Request

    In compliance with the requirement for opportunity for public 
comment on proposed data collection projects (section 3506(c)(2)(A) of 
Title 44, United States Code, as amended by the Paperwork Reduction Act 
of 1995, Pub. L. 104-13), the Health Resources and Services 
Administration (HRSA) publishes periodic summaries of proposed projects 
being developed for submission to the Office of Management and Budget 
(OMB) under the Paperwork Reduction Act of 1995. To request more 
information on the proposed project or to obtain a copy of the data 
collection plans and draft instruments, call the HRSA Reports Clearance 
Officer on (301) 443-1129.
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper performance of the functions of 
the agency, including whether the information shall have practical 
utility; (b) the accuracy of the agency's estimate of the burden of the 
proposed collection of information; (c) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (d) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques or other 
forms of information technology.

Proposed Project: Drug Pricing Program Reporting Requirements (OMB No. 
0915-0176)--Extension

    Section 602 of Public Law 102-585, the Veterans Health Care Act of 
1992, enacted section 340B of the Public Health Service Act (PHS Act) 
``Limitation on Prices of Drugs Purchased by Covered Entities.'' 
Section 340B provides that a manufacturer who sells covered outpatient 
drugs to eligible entities must sign a pharmaceutical pricing agreement 
with the Secretary of Health and Human Services in which the 
manufacturer agrees to charge a price for covered outpatient drugs that 
will not exceed an amount determined under a statutory formula.
    Covered entities which choose to participate in the section 340B 
drug discount program must comply with the requirements of 340B(a)(5) 
of the PHS Act. Section 340B(a)(5)(A) prohibits a covered entity from 
accepting a discount for a drug that would also generate a Medicaid 
rebate. Further, section 340B(a)(5)(B) prohibits a covered entity from 
reselling or otherwise transferring a discounted drug to a person who 
is not a patient of the entity.
    In response to the statutory mandate of section 340B(a)(5)(C) to 
develop audit guidelines and because of the potential for disputes 
involving covered entities and participating drug manufacturers, the 
HRSA Office of Pharmacy Affairs (OPA) has developed a dispute 
resolution process for manufacturers and covered entities as well as 
manufacturer guidelines for audit of covered entities.
    Audit Guidelines: A manufacturer will be permitted to conduct an 
audit only when there is reasonable cause to believe a violation of 
section 340B(a)(5)(A) or (B) has occurred. The manufacturer must notify 
the covered entity in writing when it believes the covered entity has 
violated the provisions of 340B. If the problem cannot be resolved, the 
manufacturer must then submit an audit work plan describing the audit 
and evidence in support of the reasonable cause standard to the HRSA 
OPA for review. The office will review the documentation to determine 
if reasonable cause exists. Once the audit is completed, the 
manufacturer will submit copies of the audit report to the HRSA OPA for 
review and resolution of the findings, as appropriate. The manufacturer 
will also submit an informational copy of the audit report to the HHS 
Office of Inspector General.
    Dispute Resolution Guidelines: Because of the potential for 
disputes involving covered entities and participating drug 
manufacturers, the HRSA OPA has developed an informal dispute 
resolution process which can be used if an entity or manufacturer is 
believed to be in violation of section 340B. Prior to filing a request 
for resolution of a dispute with the HRSA OPA, the parties must 
attempt, in good faith, to resolve the dispute. All parties involved in 
the dispute must maintain written documentation as evidence of a good 
faith attempt to resolve the dispute. If the dispute is not resolved 
and dispute resolution is desired, a party must submit a written 
request for a review of the dispute to the HRSA OPA. A committee 
appointed to review the documentation will send a letter to the party 
alleged to have committed a violation. The party will be asked to 
provide a response to or a rebuttal of the allegations.
    The estimates of annualized burden are as follows:

----------------------------------------------------------------------------------------------------------------
                                     Number of     Responses per       Total         Hours per     Total burden
      Reporting requirement         respondents     respondent       responses       response          hours
----------------------------------------------------------------------------------------------------------------
                                                     Audits
----------------------------------------------------------------------------------------------------------------
Audit Notification of Entity*...               2               1               2               4               8
Audit Work Plan.................               1               1               1               8               8

[[Page 41029]]

 
Audit Report....................               1               1               1               1               1
Entity Response.................               0               0               0               0               0
----------------------------------------------------------------------------------------------------------------
                                               Dispute Resolution
----------------------------------------------------------------------------------------------------------------
Mediation Request...............               2               4               8              10              80
Rebuttal........................               2               1               2              16              32
                                 -------------------------------------------------------------------------------
    Total Reporting.............               8  ..............              14  ..............             129
----------------------------------------------------------------------------------------------------------------
                                            Recordkeeping Requirement
----------------------------------------------------------------------------------------------------------------
Dispute Records.................              10               1              10              .5               5
                                 -------------------------------------------------------------------------------
    Total Recordkeeping.........              10  ..............  ..............  ..............               5
----------------------------------------------------------------------------------------------------------------
*Prepared by the manufacturer.

    Send comments to Susan G. Queen, Ph.D., HRSA Reports Clearance 
Officer, Room 10-33, Parklawn Building, 5600 Fishers Lane, Rockville, 
MD 20857. Written comments should be received within 60 days of this 
notice.

    Dated: July 12, 2006.
Cheryl R. Dammons,
Director, Division of Policy Review and Coordination.
[FR Doc. E6-11440 Filed 7-18-06; 8:45 am]
BILLING CODE 4165-15-P