Notice of Meeting of the Advisory Council on Blood Stem Cell Transplantation, 65610-65611 [E8-26272]

Download as PDF 65610 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: BILLING CODE 4165–15–P VerDate Aug<31>2005 15:23 Nov 03, 2008 Jkt 217001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 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, E:\FR\FM\04NON1.SGM 04NON1 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 http:// VerDate Aug<31>2005 15:23 Nov 03, 2008 Jkt 217001 bloodcell.transplant.hrsa.gov/ABOUT/ Advisory_Council/index.html. 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 http://bloodcell.transplant.hrsa.gov/ ABOUT/Advisory_Council/index.html. 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 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 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 E:\FR\FM\04NON1.SGM 04NON1

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[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]


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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.

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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 http://
bloodcell.transplant.hrsa.gov/ABOUT/Advisory_Council/index.html. 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 http://
bloodcell.transplant.hrsa.gov/ABOUT/Advisory_Council/index.html.

    Dated: October 28, 2008.
Elizabeth M. Duke,
Administrator.
 [FR Doc. E8-26272 Filed 11-3-08; 8:45 am]
BILLING CODE 4165-15-P