Notice of Meeting of the Advisory Council on Blood Stem Cell Transplantation, 65610-65611 [E8-26272]
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Federal Register / Vol. 73, No. 214 / Tuesday, November 4, 2008 / Notices
responsibility to administer the 340B
Drug Pricing Program while maintaining
efficiency, transparency and integrity,
the HRSA Office of Pharmacy Affairs
(OPA) developed a process of
registration of covered entities to enable
it to address those mandates.
Enrollment/Registration
To enroll and certify the eligible
federally funded grantees and other
safety net health care providers, OPA
requires entities to submit
administrative information (e.g.,
shipping and billing arrangements,
Medicaid participation), certifying
information and signatures from
appropriate grantee level or entity level
authorizing officials and state/local
government representatives. The
purpose of this registration information
is to determine eligibility for the 340B
program. This information is received
and verified according to 340B
requirements and entered into the 340B
database. Accurate records are critical to
implementation of the 340B legislation
especially to prevent diversion and
duplicate discounts. To maintain
accurate records, the OPA requests
entities to submit modifications to any
administrative information that they
submitted when initially enrolling into
the program. The burden requirement
for these processes is minimal.
Recertification
The purposes of recertification are to
request that 340B covered entities
annually certify program eligibility and
confirm the accuracy of all information
in the covered entity’s 340B database
record. Recertification is an electronic
process that will require the covered
entity to review the current database
record and submit required edits (i.e.,
Number of
respondents
Reporting requirement
Responses
per
respondent
covered entity name and address
changes, changes to 340B designated
contact information, billing and
shipping arrangements). The
recertification process will pose a
minimal burden to 340B covered
entities.
Contract Pharmacy Self-Certification
In order to ensure that drug
manufacturers and drug wholesalers
recognize contract pharmacy
arrangements, covered entities that elect
to utilize a contract pharmacy are
required to submit to OPA a selfcertification form similar to the
registration form that they have signed
an agreement with the contract
pharmacy.
The estimates of annualized burden
are as follows:
Total
responses
Hours per
response
Total burden
hours
DSH & CHILDREN’S HOSPITAL ENROLLMENT, ADDITIONS & RECERTIFICATIONS
340B Program Registrations & Certifications for Disproportionate Share Hospitals ......................................
340B Program Registrations & Certifications for Children’s Hospitals ............................................................
Certifications to Enroll DSH & Children’s Hospitals Outpatient facilities to 340B Program ................................
DSH & Children’s Hospitals’ Annual Recertification ........
70
1
70
.25
17.5
80
1
80
.25
20
180
937
1
1
180
937
.083
.5
14.94
468.5
REGISTRATION FOR ENTITIES OTHER THAN HOSPITALS & RECERTIFICATIONS
340B Registration Form (Family Planning, STD, TB,
and others) ...................................................................
Family Planning Annual Recertification ...........................
STD & TB Annual Recertification ....................................
Other Entity Annual Recertification for entities other
than DSHs, FP, STD or TB entities .............................
Submission of Administrative Changes for any entity .....
170
85
111
1
47
11
170
3995
1221
.083
.083
.083
14.11
331.59
101.34
400
460
10
1
4000
460
.083
.083
332
38.18
166
CONTRACTED PHARMACY SERVICES REGISTRATION & RECERTIFICATIONS
Contracted Pharmacy Services Registration ...................
2000
1
2000
.083
TOTAL ......................................................................
* 4493
........................
13,313
..........................
1504.16
* The total number of respondents may be overestimated since we are unable to avoid duplication of respondents who submit information to
the OPA over the course of participation in the 340B Drug Pricing Program, via the initial registration process to any updates/modifications and
enrolling contract pharmacies, if applicable, to the recertification process.
dwashington3 on PRODPC61 with NOTICES
E-mail comments to
paperwork@hrsa.gov or mail the 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: October 28, 2008.
Alexandra Huttinger,
Director, Division of Policy Review and
Coordination.
[FR Doc. E8–26271 Filed 11–3–08; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Notice of Meeting of the Advisory
Council on Blood Stem Cell
Transplantation
Health Resources and Services
Administration, HHS.
AGENCY:
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Notice of Meeting of the
Advisory Council on Blood Stem Cell
Transplantation.
ACTION:
SUMMARY: Pursuant to Public Law 92–
463, the Federal Advisory Committee
Act, as amended (5 U.S.C. Appendix 2),
notice is hereby given of the third
meeting of the Advisory Council on
Blood Stem Cell Transplantation
(ACBSCT), Department of Health and
Human Services (HHS). The meeting
will be held from approximately 8:30
a.m. to 5 p.m. on December 15, 2008,
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dwashington3 on PRODPC61 with NOTICES
Federal Register / Vol. 73, No. 214 / Tuesday, November 4, 2008 / Notices
and from 8:30 a.m. to 3:30 p.m. on
December 16, 2008, at the Hyatt
Regency Bethesda, One Bethesda Metro
Center, Bethesda, Maryland 20814. The
meeting will be open to the public;
however, seating is limited and preregistration is encouraged (see below).
SUPPLEMENTARY INFORMATION: Pursuant
to Public Law 109–129, 42 U.S.C. 274k
(section 379 of the Public Health Service
Act, as amended) the ACBSCT was
established to advise the Secretary of
HHS and the Administrator, HRSA, on
matters related to the activities of the
C.W. Bill Young Cell Transplantation
Program (Program) and the National
Cord Blood Inventory (NCBI) Program.
ACBSCT is composed of up to 25
members, including the Chair, serving
as Special Government Employees. The
current membership includes
representatives of marrow donor centers
and marrow transplant centers;
representatives of cord blood banks and
participating birthing hospitals;
recipients of a bone marrow transplant;
recipients of a cord blood transplant;
persons who require such transplants;
family members of such a recipient or
family members of a patient who has
requested the assistance of the Program
in searching for an unrelated donor of
bone marrow or cord blood; persons
with expertise in bone marrow and cord
blood transplantation; persons with
expertise in typing, matching, and
transplant outcome data analysis;
persons with expertise in the social
sciences; basic scientists with expertise
in the biology of adult stem cells;
ethicists; hematology and transfusion
medicine researchers with expertise in
adult blood stem cells; persons with
expertise in cord blood processing; and
members of the general public.
The Council will hear reports from
four of the ACBSCT Work Groups: Cord
Blood Accreditation Organization and
Recognition Process, Need for Public
Funding for Required Data
Documentation, Scientific Factors
Necessary to Define a Cord Blood Unit
as High Quality, and Program
Confidentiality/Policies for Cord Blood
Donors. The Council also will hear
presentations and discussions on
Product Labeling; the Blood Stem Cell
Transplant Physician Shortage; CMS
Evaluation of Coverage for
Myelodysplastic Syndromes; Models for
Cord Blood Donor Recruitment; and the
Center for International Blood and
Marrow Transplant Research update on
several research activities.
The draft meeting agenda and a
registration form will be available on
November 17, 2008, on the HRSA’s
Program Web site at https://
VerDate Aug<31>2005
15:23 Nov 03, 2008
Jkt 217001
bloodcell.transplant.hrsa.gov/ABOUT/
Advisory_Council/. The
completed registration form should be
submitted by facsimile to Professional
and Scientific Associates (PSA), the
logistical support contractor for the
meeting, at fax number (703) 234–1701
ATTN: Lilly Cho. Registration can also
be completed electronically at https://
www.team-psa.com/dot/fall2008/
acbsct/. Individuals without access to
the Internet who wish to register may
call Lilly Cho with PSA at (703) 234–
1733.
Individuals who plan to attend the
meeting and need special assistance,
such as sign language interpretation or
other reasonable accommodations,
should notify the ACBSCT Executive
Secretary, Remy Aronoff, in advance of
the meeting. Mr. Aronoff may be
reached by telephone at 301–443–3264,
e-mail: Remy.Aronoff@hrsa.hhs.gov or
in writing at the address provided
below. Management and support
services for ACBSCT functions are
provided by the Division of
Transplantation, Healthcare Systems
Bureau, Health Resources and Services
Administration, 5600 Fishers Lane,
Parklawn Building, Room 12C–06,
Rockville, Maryland 20857; telephone
number 301–443–7577.
After the presentations and Council
discussions, members of the public will
have an opportunity to provide
comments. Because of the Council’s full
agenda and the timeframe in which to
cover the agenda topics, public
comment will be limited. All public
comments will be included in the
record of the ACBSCT meeting. Meeting
summary notes will be made available
on the HRSA’s Program Web site at
https://bloodcell.transplant.hrsa.gov/
ABOUT/Advisory_Council/.
Dated: October 28, 2008.
Elizabeth M. Duke,
Administrator.
[FR Doc. E8–26272 Filed 11–3–08; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Proposed Collection;
Comment Request
In compliance with Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 concerning
opportunity for public comment on
proposed collections of information, the
Substance Abuse and Mental Health
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65611
Services Administration (SAMHSA)
will publish periodic summaries of
proposed projects. To request more
information on the proposed projects or
to obtain a copy of the information
collection plans, call the SAMHSA
Reports Clearance Officer on (240) 276–
1243.
Comments are invited on: (a) Whether
the proposed collections of information
are 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: Notification of Intent
to Use Schedule III, IV, or V Opioid
Drugs for the Maintenance and
Detoxification Treatment of Opiate
Addiction Under 21 U.S.C. 823(g)(2)
(OMB No. 0930–0234)—Revision
The Drug Addiction Treatment Act of
2000 (‘‘DATA,’’ Pub. L. 106–310)
amended the Controlled Substances Act
(21 U.S.C. 823(g)(2)) to permit
practitioners (physicians) to seek and
obtain waivers to prescribe certain
approved narcotic treatment drugs for
the treatment of opiate addiction. The
legislation sets eligibility requirements
and certification requirements as well as
an interagency notification review
process for physicians who seek
waivers. The legislation was amended
in 2005 to eliminate the patient limit for
physicians in group practices, and in
2006, to permit certain physicians to
treat up to 100 patients.
To implement these provisions,
SAMHSA developed a notification form
(SMA–167) that facilitates the
submission and review of notifications.
The form provides the information
necessary to determine whether
practitioners (i.e., independent
physicians) meet the qualifications for
waivers set forth under the new law.
Use of this form will enable physicians
to know they have provided all
information needed to determine
whether practitioners are eligible for a
waiver.
However, there is no prohibition on
use of other means to provide requisite
information. The Secretary will convey
notification information and
determinations to the Drug Enforcement
Administration (DEA), which will
assign an identification number to
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]]>Agencies
[Federal Register Volume 73, Number 214 (Tuesday, November 4, 2008)]
[Notices]
[Pages 65610-65611]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-26272]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Notice of Meeting of the Advisory Council on Blood Stem Cell
Transplantation
AGENCY: Health Resources and Services Administration, HHS.
ACTION: Notice of Meeting of the Advisory Council on Blood Stem Cell
Transplantation.
-----------------------------------------------------------------------
SUMMARY: Pursuant to Public Law 92-463, the Federal Advisory Committee
Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the
third meeting of the Advisory Council on Blood Stem Cell
Transplantation (ACBSCT), Department of Health and Human Services
(HHS). The meeting will be held from approximately 8:30 a.m. to 5 p.m.
on December 15, 2008,
[[Page 65611]]
and from 8:30 a.m. to 3:30 p.m. on December 16, 2008, at the Hyatt
Regency Bethesda, One Bethesda Metro Center, Bethesda, Maryland 20814.
The meeting will be open to the public; however, seating is limited and
pre-registration is encouraged (see below).
SUPPLEMENTARY INFORMATION: Pursuant to Public Law 109-129, 42 U.S.C.
274k (section 379 of the Public Health Service Act, as amended) the
ACBSCT was established to advise the Secretary of HHS and the
Administrator, HRSA, on matters related to the activities of the C.W.
Bill Young Cell Transplantation Program (Program) and the National Cord
Blood Inventory (NCBI) Program. ACBSCT is composed of up to 25 members,
including the Chair, serving as Special Government Employees. The
current membership includes representatives of marrow donor centers and
marrow transplant centers; representatives of cord blood banks and
participating birthing hospitals; recipients of a bone marrow
transplant; recipients of a cord blood transplant; persons who require
such transplants; family members of such a recipient or family members
of a patient who has requested the assistance of the Program in
searching for an unrelated donor of bone marrow or cord blood; persons
with expertise in bone marrow and cord blood transplantation; persons
with expertise in typing, matching, and transplant outcome data
analysis; persons with expertise in the social sciences; basic
scientists with expertise in the biology of adult stem cells;
ethicists; hematology and transfusion medicine researchers with
expertise in adult blood stem cells; persons with expertise in cord
blood processing; and members of the general public.
The Council will hear reports from four of the ACBSCT Work Groups:
Cord Blood Accreditation Organization and Recognition Process, Need for
Public Funding for Required Data Documentation, Scientific Factors
Necessary to Define a Cord Blood Unit as High Quality, and Program
Confidentiality/Policies for Cord Blood Donors. The Council also will
hear presentations and discussions on Product Labeling; the Blood Stem
Cell Transplant Physician Shortage; CMS Evaluation of Coverage for
Myelodysplastic Syndromes; Models for Cord Blood Donor Recruitment; and
the Center for International Blood and Marrow Transplant Research
update on several research activities.
The draft meeting agenda and a registration form will be available
on November 17, 2008, on the HRSA's Program Web site at https://
bloodcell.transplant.hrsa.gov/ABOUT/Advisory_Council/. The
completed registration form should be submitted by facsimile to
Professional and Scientific Associates (PSA), the logistical support
contractor for the meeting, at fax number (703) 234-1701 ATTN: Lilly
Cho. Registration can also be completed electronically at https://
www.team-psa.com/dot/fall2008/acbsct/. Individuals without access to
the Internet who wish to register may call Lilly Cho with PSA at (703)
234-1733.
Individuals who plan to attend the meeting and need special
assistance, such as sign language interpretation or other reasonable
accommodations, should notify the ACBSCT Executive Secretary, Remy
Aronoff, in advance of the meeting. Mr. Aronoff may be reached by
telephone at 301-443-3264, e-mail: Remy.Aronoff@hrsa.hhs.gov or in
writing at the address provided below. Management and support services
for ACBSCT functions are provided by the Division of Transplantation,
Healthcare Systems Bureau, Health Resources and Services
Administration, 5600 Fishers Lane, Parklawn Building, Room 12C-06,
Rockville, Maryland 20857; telephone number 301-443-7577.
After the presentations and Council discussions, members of the
public will have an opportunity to provide comments. Because of the
Council's full agenda and the timeframe in which to cover the agenda
topics, public comment will be limited. All public comments will be
included in the record of the ACBSCT meeting. Meeting summary notes
will be made available on the HRSA's Program Web site at https://
bloodcell.transplant.hrsa.gov/ABOUT/Advisory_Council/.
Dated: October 28, 2008.
Elizabeth M. Duke,
Administrator.
[FR Doc. E8-26272 Filed 11-3-08; 8:45 am]
BILLING CODE 4165-15-P
