Agency Information Collection Activities: Proposed Collection: Comment Request, 41028-41029 [E6-11440]
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41028
Federal Register / Vol. 71, No. 138 / Wednesday, July 19, 2006 / Notices
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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 ...................................................................
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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
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]]>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]
-----------------------------------------------------------------------
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
