Federal Register / Vol. 74, No. 155 / Thursday, August 13, 2009 / Notices 40821 

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 

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: 

Instrument Number of 

respondents 

Responses 

per 

respondent 

Total 

responses 

Hours per 

response 

Total burden 

hours 

AENT .................................................................................... 500 1 500 1.5 750 

NAT ...................................................................................... 100 1 100 1 100 

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 

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 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 

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 


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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 

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: 

Reporting requirement Number of 

respondents 

Responses 

per 

respondent 

Total 

responses 

Hours per 

response 

Total burden 

hours 

DSH & Children’s Hospital Enrollment, Additions & Recertifications 

340B Program Registrations & Certifications for Disproportionate Share Hospitals ...................................... 70 1 70 .25 17 .5 

340B Program Registrations & Certifications for Children’s Hospitals ............................................................ 80 1 80 .25 20 

Certifications to Enroll DSH & Children’s Hospitals Outpatient facilities to 340B Program ................................ 180 1 180 .083 14 .94 

DSH & Children’s Hospitals’ Annual Recertification ........ 937 1 937 .5 468 .5 

Registration for Entities Other Than Hospitals & Recertifications 

340B Registration Form (Family Planning, STD, TB, 

and others) ................................................................... 170 1 170 .083 14 .11 

Family Planning Annual Recertification ........................... 85 47 3995 .083 331 .59 

STD & TB Annual Recertification .................................... 111 11 1221 .083 101 .34 

Other Entity Annual Recertification for entities other 

than DSHs, FP, STD or TB entities ............................. 400 10 4000 .083 332 

Submission of Administrative Changes for any entity ..... 460 1 460 .083 38 .18 

Contracted Pharmacy Services Registration & Recertifications 

Contracted Pharmacy Services Registration ................... 2000 1 2000 .083 166 

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 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] 

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 

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 


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