Agency Information Collection Activities: Submission for OMB Review; Comment Request, 40821-40822 [E9-19381]

Download as PDF 40821 Federal Register / Vol. 74, No. 155 / Thursday, August 13, 2009 / Notices 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: Advanced Education Nursing Traineeship (AENT) and Nurse Anesthetist Traineeship (NAT) (OMB No. 0915–0305): Revision The Health Resources and Services Administration (HRSA) provides training grants to educational institutions to increase the numbers of advanced education nurses through the Advanced Education Nursing Traineeship (AENT) program and the Nurse Anesthetist Traineeship (NAT) program. HRSA developed the AENT and NAT tables for the application guidances and the Nurse Traineeship Database for the two nursing traineeship programs. The AENT and NAT tables are used annually by grant applicants that are applying for AENT and NAT funding. The funds appropriated for the AENT and NAT programs are distributed among eligible institutions based on a formula. Award amounts are based on enrollment and graduate data reported on the tables and two funding factors (Statutory Funding Preference and Statutory Special Consideration). The AENT and NAT tables include information on program participants such as the number of enrollees, projected data on enrollees and graduates for the following academic year, number of trainees supported, number of graduates, number of graduates supported and the types of programs they are enrolling into and/or from which they are graduating. AENT and NAT applicants will have a single Number of respondents Instrument Responses per respondent access point to submit their grant applications including the tables. Applications are submitted in two phases: Grants.gov (Phase 1) and the HRSA Electronic Handbooks (Phase 2). These tables will be available electronically through the HRSA Electronic Handbooks (Phase 2) for applicants to submit their AENT and/or NAT grant application(s). The tables are also used in the Nurse Traineeship Database which is used by Division of Nursing staff and not the applicants. Data from the tables will be used in the award determination and validation process. Additionally, the data will be used to ensure programmatic compliance, report to Congress and policymakers on the program accomplishments, and formulate and justify future budgets for these activities submitted to OMB and Congress. The burden estimate for this project is as follows: Total responses Hours per response Total burden hours AENT .................................................................................... NAT ...................................................................................... 500 100 1 1 500 100 1.5 1 750 100 Total .............................................................................. 600 ........................ 600 ........................ 850 E-mail comments to paperwork@hrsa.gov or mail to 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: August 5, 2009. Alexandra Huttinger, Director, Division of Policy Review and Coordination. [FR Doc. E9–19393 Filed 8–12–09; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration erowe on DSK5CLS3C1PROD with NOTICES Agency Information Collection Activities: Submission for OMB Review; Comment Request Periodically, the Health Resources and Services Administration (HRSA) publishes abstracts of information collection requests under review by the Office of Management and Budget (OMB), in compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). To request a copy of the clearance requests submitted to VerDate Nov<24>2008 15:29 Aug 12, 2009 Jkt 217001 OMB for review, e-mail paperwork@hrsa.gov or call the HRSA Reports Clearance Office on (301) 443– 1129. The following request has been submitted to the Office of Management and Budget for review under the Paperwork Reduction Act of 1995: Proposed Project: Enrollment and ReCertification of Entities in the 340B Drug Pricing Program [NEW] 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 Pricing 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 PO 00000 Frm 00015 Fmt 4703 Sfmt 4703 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)(9) to notify manufacturers of the identities of covered entities and the mandate of section 340B(a)(5)(A)(ii) to establish a mechanism to ensure against duplicate discounts and the ongoing 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 E:\FR\FM\13AUN1.SGM 13AUN1 40822 Federal Register / Vol. 74, No. 155 / Thursday, August 13, 2009 / Notices 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. Contract Pharmacy Self-Certification In order to ensure that drug manufacturers and drug wholesalers recognize contract pharmacy Number of respondents Reporting requirement Responses per respondent 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 .083 .......................... 166 1504.16 Contracted Pharmacy Services Registration & Recertifications Contracted Pharmacy Services Registration ................... Total .......................................................................... 2000 * 4493 1 ........................ 2000 13,313 * 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. Written comments and recommendations concerning the proposed information collection should be sent within 30 days of this notice to the desk officer for HRSA, either by email to OIRA_submission@omb.eop.gov or by fax to 202–395–6974. Please direct all correspondence to the ‘‘attention of the desk officer for HRSA.’’ Dated: August 5, 2009. Alexandra Huttinger, Director, Division of Policy Review and Coordination. [FR Doc. E9–19381 Filed 8–12–09; 8:45 am] erowe on DSK5CLS3C1PROD with NOTICES BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Health Promotion and Disease Prevention Research Centers, Special Interest Project Competitive Supplements (SIPS) (U48 Panels N, O and P), RFA– DP09–101SUPP09, Initial Review In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), the Centers for Disease Control and Prevention (CDC) announces the aforementioned meeting. Time and Dates: 9 a.m.–5 p.m., August 5, 2009 (closed). 9 a.m.–5 p.m., August 6, 2009 (closed). 9 a.m.–5 p.m., August 7, 2009 (closed). Place: Westin Hotel, 3377 Peachtree Road, NE., Atlanta, GA, 30326, Telephone (678) 500–3100. Status: The meeting will be closed to the public in accordance with provisions set VerDate Nov<24>2008 15:29 Aug 12, 2009 Jkt 217001 PO 00000 Frm 00016 Fmt 4703 Sfmt 4703 forth in section 552b(c)(4) and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92–463. Matters To Be Discussed: The meeting will include the review, discussion, and evaluation of the application received in response to ‘‘Health Promotion and Disease Prevention Research Centers, Special Interest Project Competitive Supplements (SIPS) (U48 Panels N, O and P), RFA–DP09–101SUPP09, initial review.’’ Contact Person for More Information: Brenda Colley-Gilbert, Ph.D., Director, Extramural Research Program Office, CCH, 47770 Buford Highway, MS K–92, Atlanta, GA 30341, Telephone (770) 488–8390. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both CDC and the Agency for Toxic Substances and Disease Registry. Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E9–19293 Filed 8–12–09; 8:45 am] BILLING CODE 4163–18–P E:\FR\FM\13AUN1.SGM 13AUN1

Agencies

[Federal Register Volume 74, Number 155 (Thursday, August 13, 2009)]
[Notices]
[Pages 40821-40822]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-19381]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities: Submission for OMB 
Review; Comment Request

    Periodically, the Health Resources and Services Administration 
(HRSA) publishes abstracts of information collection requests under 
review by the Office of Management and Budget (OMB), in compliance with 
the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). To request 
a copy of the clearance requests submitted to OMB for review, e-mail 
paperwork@hrsa.gov or call the HRSA Reports Clearance Office on (301) 
443-1129.
    The following request has been submitted to the Office of 
Management and Budget for review under the Paperwork Reduction Act of 
1995:

Proposed Project: Enrollment and Re-Certification of Entities in the 
340B Drug Pricing Program [NEW]

    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 Pricing 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)(9) to 
notify manufacturers of the identities of covered entities and the 
mandate of section 340B(a)(5)(A)(ii) to establish a mechanism to ensure 
against duplicate discounts and the ongoing 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

[[Page 40822]]

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.

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 self-
certification form similar to the registration form that they have 
signed an agreement with the contract pharmacy.
    The Estimates of annualized burden are as follows:

----------------------------------------------------------------------------------------------------------------
                                     Number of     Responses per       Total         Hours per     Total burden
      Reporting requirement         respondents     respondent       responses       response          hours
----------------------------------------------------------------------------------------------------------------
                       DSH & Children's Hospital Enrollment, Additions & Recertifications
----------------------------------------------------------------------------------------------------------------
340B Program Registrations &                  70               1              70            .25            17.5
 Certifications for
 Disproportionate Share
 Hospitals......................
340B Program Registrations &                  80               1              80            .25            20
 Certifications for Children's
 Hospitals......................
Certifications to Enroll DSH &               180               1             180            .083           14.94
 Children's Hospitals Outpatient
 facilities to 340B Program.....
DSH & Children's Hospitals'                  937               1             937            .5            468.5
 Annual Recertification.........
----------------------------------------------------------------------------------------------------------------
                        Registration for Entities Other Than Hospitals & Recertifications
----------------------------------------------------------------------------------------------------------------
340B Registration Form (Family               170               1             170            .083           14.11
 Planning, STD, TB, and others).
Family Planning Annual                        85              47            3995            .083          331.59
 Recertification................
STD & TB Annual Recertification.             111              11            1221            .083          101.34
Other Entity Annual                          400              10            4000            .083          332
 Recertification for entities
 other than DSHs, FP, STD or TB
 entities.......................
Submission of Administrative                 460               1             460            .083           38.18
 Changes for any entity.........
----------------------------------------------------------------------------------------------------------------
                          Contracted Pharmacy Services Registration & Recertifications
----------------------------------------------------------------------------------------------------------------
Contracted Pharmacy Services                2000               1            2000            .083          166
 Registration...................
    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.

    Written comments and recommendations concerning the proposed 
information collection should be sent within 30 days of this notice to 
the desk officer for HRSA, either by e-mail to OIRA_submission@omb.eop.gov or by fax to 202-395-6974. Please direct all 
correspondence to the ``attention of the desk officer for HRSA.''

    Dated: August 5, 2009.
Alexandra Huttinger,
Director, Division of Policy Review and Coordination.
[FR Doc. E9-19381 Filed 8-12-09; 8:45 am]
BILLING CODE 4165-15-P