National Practitioner Data Bank: Change in User Fees, 12367-12368 [E6-3323]
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Federal Register / Vol. 71, No. 47 / Friday, March 10, 2006 / Notices
and is not intended for implementation
at this time. Interested persons may
submit to the Division of Dockets
Management (see ADDRESSES) written or
electronic comments regarding the draft
guidance. Submit a single copy of
electronic comments or two paper
copies of any mailed comments, except
that individuals may submit one paper
copy. Comments are to be identified
with the docket number found in
brackets in the heading of this
document. A copy of the draft guidance
and received comments are available for
public examination in the Division of
Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
IV. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/cber/guidelines.htm
or https://www.fda.gov/ohrms/dockets/
default.htm.
Dated: March 1, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–3371 Filed 3–9–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006D–0083]
Draft Guidance for Industry on Clinical
Data Needed to Support the Licensure
of Trivalent Inactivated Influenza
Vaccines; Availability
AGENCY:
Food and Drug Administration,
HHS.
dsatterwhite on PROD1PC65 with PROPOSAL
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft document entitled
‘‘Guidance for Industry: Clinical Data
Needed to Support the Licensure of
Trivalent Inactivated Influenza
Vaccines,’’ dated March 2006. The draft
guidance document is intended to
provide to sponsors of trivalent
inactivated influenza vaccines guidance
on the clinical data needed to support
a Biologics License Application (BLA).
The draft guidance summarizes clinical
development approaches to facilitate
and expedite the licensure of new
trivalent inactivated influenza vaccines
and addresses both traditional and
accelerated approval.
DATES: Submit written or electronic
comments on the draft guidance by June
8, 2006 to ensure their adequate
consideration in preparation of the final
VerDate Aug<31>2005
20:31 Mar 09, 2006
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guidance. General comments on agency
guidance documents are welcome at any
time.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Office of Communication, Training, and
Manufacturers Assistance (HFM–40),
Center for Biologics Evaluation and
Research (CBER), Food and Drug
Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852–1448.
Send one self-addressed adhesive label
to assist the office in processing your
requests. The draft guidance may also be
obtained by mail by calling CBER at 1–
800–835–4709 or 301–827–1800. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
Submit written comments on the draft
guidance to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT:
Valerie A. Butler, Center for Biologics
Evaluation and Research (HFM–17),
Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville,
MD 20852–1448, 301–827–6210.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft document entitled ‘‘Guidance for
Industry: Clinical Data Needed to
Support the Licensure of Trivalent
Inactivated Influenza Vaccines,’’ dated
March 2006. The draft guidance is
intended to provide to sponsors of
trivalent inactivated influenza vaccines
guidance on the clinical data needed to
support a BLA. The draft guidance
summarizes clinical development
approaches to facilitate and expedite the
licensure of new ‘‘split virus’’ trivalent
inactivated influenza vaccines and
addresses both traditional and
accelerated approval. The approaches
are also applicable to vaccines made
with other manufacturing processes;
e.g., whole virus inactivated, cellculture based inactivated, recombinant
protein, and adjuvanted influenza
vaccines. The draft guidance does not
address live attenuated influenza
vaccines or influenza vaccines that do
not contain a hemagglutinin component.
The draft guidance also does not
address the nonclinical development of
investigational vaccines, or the
chemistry, manufacturing, control, or
inspection of the manufacturing facility
needed for licensure.
The draft guidance is being issued
consistent with FDA’s good guidance
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12367
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent FDA’s current thinking on this
topic. It does not create or confer any
rights for or on any person and does not
operate to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the requirement
of the applicable statutes and
regulations.
II. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The information
collection provisions in this guidance
for 21 CFR part 601 have been approved
under OMB control number 0910–0338.
III. Comments
The draft guidance is being
distributed for comment purposes only
and is not intended for implementation
at this time. Interested persons may
submit to the Division of Dockets
Management (see ADDRESSES) written or
electronic comments regarding the draft
guidance. Submit a single copy of
electronic comments or two paper
copies of any mailed comments, except
that individuals may submit one paper
copy. Comments are to be identified
with the docket number found in the
brackets in the heading of this
document. A copy of the draft guidance
and received comments are available for
public examination in the Division of
Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
IV. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/cber/guidelines.htm
or https://www.fda.gov/ohrms/dockets/
default.htm.
Dated: February 28, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–3370 Filed 3–9–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Practitioner Data Bank:
Change in User Fees
Health Resources and Services
Administration, HHS.
AGENCY:
E:\FR\FM\10MRN1.SGM
10MRN1
12368
ACTION:
Federal Register / Vol. 71, No. 47 / Friday, March 10, 2006 / Notices
Notice.
SUMMARY: The Health Resources and
Services Administration (HRSA),
Department of Health and Human
Services (HHS), is announcing a fifty
cent increase in the fee charged to
entities authorized to request
information from the National
Practitioner Data Bank (NPDB) for all
queries. The new fee will be $4.75.
There will be no change to the $8.00
self-query fee.
DATES: This change will be effective
May 9, 2006.
FOR FURTHER INFORMATION CONTACT:
Mark Pincus, Branch Chief, Practitioner
Data Banks Branch, Office of Workforce
Evaluation and Quality Assurance,
Bureau of Health Professions, Health
Resources and Services Administration,
Parklawn Building, Rm 8C–103, 5600
Fishers Lane, Rockville, MD 20857, Tel:
301–443–2300, E-mail:
policyanalysis@hrsa.gov.
The
current fee structure ($4.25 per name)
was announced in the Federal Register
on April 22, 2003 (68 FR 19837) and
became effective on July 1, 2003. All
entity queries are submitted and query
responses received through the NPDB’s
Integrated Query and Reporting Service
(IQRS) and paid via an electronic funds
transfer or credit card.
SUPPLEMENTARY INFORMATION:
The NPDB is authorized by the Health
Care Quality Improvement Act of 1986
(the Act), Title IV of Public Law 99–660,
as amended (42 U.S.C. 11101 et seq.).
Section 427(b)(4) of the Act authorizes
the establishment of fees for the costs of
processing requests for disclosure and of
providing such information.
Final regulations at 45 CFR part 60 set
forth the criteria and procedures for
information to be reported to and
disclosed by the NPDB. Section 60.3 of
these regulations defines the terms used
in this announcement.
In determining any changes in the
amount of the user fee, the Department
uses the criteria set forth in section
60.12(b) of the regulations, as well as
allowable costs pursuant to Public Law
109–77, as amended, and Title II,
Division F, Departments of Labor,
Health and Human Services, and
Education, and Related Agencies
Appropriation Act for the Consolidated
Appropriations Act, 2005, Public Law
108–447. These laws require that the
Department recover the full costs of
operating the Data Bank through user
fees. Paragraph (b) of the regulations
states:
‘‘The amount of each fee will be
determined based on the following
criteria:
(1) Use of electronic data processing
equipment to obtain information—the
actual cost for the service, including
Fee per
name in
query
Query method
Entity query (via internet with electronic payment) ........................
Practitioner self-query .....................................................................
The Department will continue to
review the user fee periodically, and
will revise it as necessary. Any changes
in the fee and their effective date will
be announced in the Federal Register.
$4.75
8.00
Examples
10 names in query. 10 × $4.75 = $47.50.
One self-query = $8.00.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
SUMMARY: In accordance with final
regulations at 45 CFR part 61,
implementing the Healthcare Integrity
and Protection Data Bank (HIPDB), the
Department is authorized to assess a fee
on all requests for information, except
requests from Federal agencies. In
accordance with § 61.13 of the HIPDB
regulations, the Department is
announcing an adjustment from $4.25 to
$4.75 in the fee charged for each query
submitted by authorized entities. There
will be no change to the current $8 selfquery fee.
Office of Inspector General
EFFECTIVE DATE:
Healthcare Integrity and Protection
Data Bank: Change in User Fees
FOR FURTHER INFORMATION CONTACT:
Dated: March 3, 2006.
Elizabeth M. Duke,
Administrator.
[FR Doc. E6–3323 Filed 3–9–06; 8:45 am]
dsatterwhite on PROD1PC65 with PROPOSAL
BILLING CODE 4165–15–P
This change will be
effective May 9, 2006.
Office of Inspector General
(OIG), HHS.
AGENCY:
ACTION:
Joel
Schaer, Office of External Affairs, (202)
619–0089.
SUPPLEMENTARY INFORMATION:
Notice.
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20:31 Mar 09, 2006
Jkt 208001
computer search time, runs, printouts,
and time of computer programmers and
operators, or other employees, (2)
Photocopying or other forms of
reproduction, such as magnetic tapes—
actual cost of the operator’s time, plus
the cost of the machine time and the
materials used, (3) Postage—actual cost,
and (4) Sending information by special
methods requested by the applicant,
such as express mail or electronic
transfer—the actual cost of the special
service.’’
Based on analysis of the comparative
costs of the various methods for filing
and paying for queries, the Department
is increasing all the entity query fees by
$0.50 per name. The practitioner selfquery fee remains at $8.00. This price
increase is justified after an evaluation
of the Data Bank’s operational costs. At
the current fee of $4.25, the Data Bank
is unable to recover full costs of
operation. In keeping with the Act, and
pursuant to the requirements of section
60.12 of the regulations, there are not
sufficient funds to recover the full costs
of operating the Data Bank without a fee
increase.
When a query is for information on
one or more physicians, dentists or
other health care practitioners, the
appropriate fee will be $4.75 multiplied
by the number of individuals about
whom information is being requested.
For examples, see the table below.
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User Fee Amount
Section 1128E(d)(2) of the Social
Security Act (the Act), as added by
section 221(a) of the Health Insurance
Portability and Accountability Act of
1996, specifically authorizes the
establishment of fees for the costs of
processing requests for disclosure and
for providing information from the
Healthcare Integrity and Protection Data
Bank (HIPDB). Final regulations at 45
CFR part 61 set forth the criteria and
procedures for information to be
reported to and disclosed by the HIPDB.
The Act also requires that the
Department recover the full costs of
operating the HIPDB through such user
fees. In determining any changes in the
amount of the user fee, the Department
employs the criteria set forth in
§ 61.13(b) of the HIPDB regulations.
E:\FR\FM\10MRN1.SGM
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]]>Agencies
[Federal Register Volume 71, Number 47 (Friday, March 10, 2006)]
[Notices]
[Pages 12367-12368]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-3323]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
National Practitioner Data Bank: Change in User Fees
AGENCY: Health Resources and Services Administration, HHS.
[[Page 12368]]
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Health Resources and Services Administration (HRSA),
Department of Health and Human Services (HHS), is announcing a fifty
cent increase in the fee charged to entities authorized to request
information from the National Practitioner Data Bank (NPDB) for all
queries. The new fee will be $4.75. There will be no change to the
$8.00 self-query fee.
DATES: This change will be effective May 9, 2006.
FOR FURTHER INFORMATION CONTACT: Mark Pincus, Branch Chief,
Practitioner Data Banks Branch, Office of Workforce Evaluation and
Quality Assurance, Bureau of Health Professions, Health Resources and
Services Administration, Parklawn Building, Rm 8C-103, 5600 Fishers
Lane, Rockville, MD 20857, Tel: 301-443-2300, E-mail:
policyanalysis@hrsa.gov.
SUPPLEMENTARY INFORMATION: The current fee structure ($4.25 per name)
was announced in the Federal Register on April 22, 2003 (68 FR 19837)
and became effective on July 1, 2003. All entity queries are submitted
and query responses received through the NPDB's Integrated Query and
Reporting Service (IQRS) and paid via an electronic funds transfer or
credit card.
The NPDB is authorized by the Health Care Quality Improvement Act
of 1986 (the Act), Title IV of Public Law 99-660, as amended (42 U.S.C.
11101 et seq.). Section 427(b)(4) of the Act authorizes the
establishment of fees for the costs of processing requests for
disclosure and of providing such information.
Final regulations at 45 CFR part 60 set forth the criteria and
procedures for information to be reported to and disclosed by the NPDB.
Section 60.3 of these regulations defines the terms used in this
announcement.
In determining any changes in the amount of the user fee, the
Department uses the criteria set forth in section 60.12(b) of the
regulations, as well as allowable costs pursuant to Public Law 109-77,
as amended, and Title II, Division F, Departments of Labor, Health and
Human Services, and Education, and Related Agencies Appropriation Act
for the Consolidated Appropriations Act, 2005, Public Law 108-447.
These laws require that the Department recover the full costs of
operating the Data Bank through user fees. Paragraph (b) of the
regulations states:
``The amount of each fee will be determined based on the following
criteria:
(1) Use of electronic data processing equipment to obtain
information--the actual cost for the service, including computer search
time, runs, printouts, and time of computer programmers and operators,
or other employees, (2) Photocopying or other forms of reproduction,
such as magnetic tapes--actual cost of the operator's time, plus the
cost of the machine time and the materials used, (3) Postage--actual
cost, and (4) Sending information by special methods requested by the
applicant, such as express mail or electronic transfer--the actual cost
of the special service.''
Based on analysis of the comparative costs of the various methods
for filing and paying for queries, the Department is increasing all the
entity query fees by $0.50 per name. The practitioner self-query fee
remains at $8.00. This price increase is justified after an evaluation
of the Data Bank's operational costs. At the current fee of $4.25, the
Data Bank is unable to recover full costs of operation. In keeping with
the Act, and pursuant to the requirements of section 60.12 of the
regulations, there are not sufficient funds to recover the full costs
of operating the Data Bank without a fee increase.
When a query is for information on one or more physicians, dentists
or other health care practitioners, the appropriate fee will be $4.75
multiplied by the number of individuals about whom information is being
requested. For examples, see the table below.
------------------------------------------------------------------------
Fee per
Query method name in Examples
query
------------------------------------------------------------------------
Entity query (via internet with $4.75 10 names in query. 10 x
electronic payment). $4.75 = $47.50.
Practitioner self-query........... 8.00 One self-query = $8.00.
------------------------------------------------------------------------
The Department will continue to review the user fee periodically,
and will revise it as necessary. Any changes in the fee and their
effective date will be announced in the Federal Register.
Dated: March 3, 2006.
Elizabeth M. Duke,
Administrator.
[FR Doc. E6-3323 Filed 3-9-06; 8:45 am]
BILLING CODE 4165-15-P
