Federal Register / Vol. 77, No. 53 / Monday, March 19, 2012 / Notices 16043 

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) of the PHS Act 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 

is to determine eligibility for the 340B 

Drug Pricing Program. This information 

is entered into the 340B database by 

entities and verified by OPA staff 

according to 340B Drug Pricing Program 

requirements. Accurate records are 

critical to implementation of the 340B 

Drug Pricing Program, especially to 

prevent drug diversion to non-eligible 

individuals as well as duplicate 

discounts from manufacturers. To 

maintain accurate records, OPA also 

requires that entities recertify eligibility 

annually and that they notify the 

program of updates to any 

administrative information that they 

submitted when initially enrolling into 

the program. The burden requirement 

for these processes is low for 

recertification and minimal for 

submitting change requests. 

Contract Pharmacy Self-Certification 

In order to ensure that drug 

manufacturers and drug wholesalers 

recognize contract pharmacy 

arrangements, covered entities that elect 

to utilize one or more contract 

pharmacies are also required to submit 

general information about the 

arrangements and certifications that 

signed agreements are in place with 

those contract pharmacies. 

The annual estimate of burden is as 

follows: 

Reporting requirement Number of 

respondents 

Responses 

per 

respondent 

Total 

responses 

Hours per 

response 

Total burden 

hours 

Hospital Enrollment, Additions & Recertifications 

340B Program Registrations & Certifications for Hospitals 546 1 546 2.0 1092 

Certifications to Enroll Hospital Outpatient Facilities ........... 606 1 606 .50 303 

Hospital Annual Recertifications .......................................... 4842 1 4842 .50 2421 

Registrations and Recertifications for Entities Other Than Hospitals 

340B Registrations for Community Health Centers ............ 253 1 253 1.0 253 

340B Registrations for Family Planning Programs, STD/TB 

Clinics and Various Other Eligible Entity Types .............. 353 1 353 1.0 353 

Community Health Center Annual Recertifications ............. 4507 1 4507 .50 2253.5 

Family Planning Annual Recertifications ............................. 3879 1 3879 .50 1939.5 

STD & TB Annual Recertifications ...................................... 2754 1 2754 .50 1377 

Annual Recertification for Entities other than Hospitals, 

Community Health Centers, Family Planning, STD or TB 

Clinics ............................................................................... 1174 1 1174 .50 587 

Other Information Collections 

Submission of Administrative Changes for any Covered 

Entity ................................................................................. 2500 1 2500 .50 1250 

Submission of Administrative Changes for any Manufacturer .................................................................................. 350 1 350 .50 175 

Contracted Pharmacy Services Registration & Recertifications 

Contracted Pharmacy Services Registration ....................... 2500 1 2500 1.0 2500 

Total .............................................................................. 24,264 ........................ 24,264 ........................ 14,504 

Email comments to 

paperwork@hrsa.gov or mail the HRSA 

Reports Clearance Officer, Room 10–29, 

Parklawn Building, 5600 Fishers Lane, 

Rockville, MD 20857. Written comments 

should be received within 60 days of 

this notice. 

Dated: March 13, 2012. 

Reva Harris, 

Acting Director, Division of Policy and 

Information Coordination. 

[FR Doc. 2012–6540 Filed 3–16–12; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Public Hearing 

SUMMARY: The National Institutes of 

Health (NIH) will hold a public meeting 

on Thursday, April 19, 2012, from 6:30– 

9:30 p.m. at Roxbury Community 

College, Main Stage, 1234 Columbus 

Avenue, Boston, MA 02120. The 


emcdonald on DSK29S0YB1PROD with NOTICES
16044 Federal Register / Vol. 77, No. 53 / Monday, March 19, 2012 / Notices 

purpose of the meeting is to solicit 

public comments regarding the Draft 

Supplementary Risk Assessment for the 

National Emerging Infectious Diseases 

Laboratories. Comments provided 

during the meeting, as well as those 

received during the public comment 

period, will be considered in NIH’s 

preparation of the Final Supplementary 

Risk Assessment for the National 

Emerging Infectious Diseases 

Laboratories. Individuals wishing to 

provide oral comments at the meeting 

must sign-in prior to the start of the 

meeting. Sign-in will begin at 5:30 p.m. 

In order to ensure everyone has the 

opportunity to speak, comments must 

be limited to no longer than three 

minutes. An agenda, slides for the 

meeting, and the draft supplementary 

risk assessment will be available at: 

http://nihblueribbonpanel-bumcneidl.od.nih.gov/meetings.asp. This 

public meeting is part of the 67-day 

public comment period initiated with 

the publication of a Notice of 

Availability in the Federal Register on 

February 24, 2012. The 67-day comment 

period began on February 24, 2012 and 

will end on May 1, 2012. Written 

comments can also be sent to: National 

Institutes of Health, ATTN: NEIDL Risk 

Assessment, 6705 Rockledge Drive, 

Suite 750, Bethesda, MD 20892, or 

emailed to NIH_BRP@od.nih.gov. 

For further information concerning 

this meeting, please contact Office of 

Biotechnology Activities, National 

Institutes of Health, 6705 Rockledge 

Drive, Suite 750, Bethesda, MD 20892; 

telephone: 301–496–9838; email: 

BRP_NIH@od.nih.gov. Requests for 

reasonable accommodations or 

translation services should be made to 

BRP_NIH@od.nih.gov no later than 

April 12, 2012. 

Dated: March 7, 2012. 

Kelly Fennington, 

Senior Health Policy Analyst, Office of 

Science Policy, National Institutes of Health. 

[FR Doc. 2012–6567 Filed 3–16–12; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Cancellation 

of Meeting 

Notice is hereby given of the 

cancellation of the National Cancer 

Institute Special Emphasis Panel, 

Clinical Assay Development Program 

(CADP), April 10, 2012, 8 a.m. to 4 p.m., 

National Institutes of Health, 6001 

Executive Boulevard, Room C, 

Rockville, MD 20852 which was 

published in the Federal Register on 

February 29, 2012, 77 FR 12318. 

The meeting has been cancelled. 

Dated: March 12, 2012. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2012–6596 Filed 3–16–12; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

[USCG–2012–0149] 

Information Collection Requests to 

Office of Management and Budget. 

AGENCY: Coast Guard, DHS. 

ACTION: Sixty-day notice requesting 

comments. 

SUMMARY: In compliance with the 

Paperwork Reduction Act of 1995, the 

U.S. Coast Guard intends to submit 

Information Collection Requests (ICRs) 

to the Office of Management and Budget 

(OMB), Office of Information and 

Regulatory Affairs (OIRA), requesting an 

extension of its approval for the 

following collection of information: 

1625–0095, Oil and Hazardous Material 

Pollution Prevention and Safety 

Records, Equivalents/Alternatives and 

Exemptions. Additionally, the U.S. 

Coast Guard requests approval of a 

revision to the following collections of 

information: 1625–0099, Requirements 

for the Use of Liquefied Petroleum Gas 

and Compressed Natural Gas as Cooking 

Fuel on Passenger Vessels and 1625– 

0103, Mandatory Ship Reporting System 

for the Northeast and Southeast Coasts 

of the United States. Our ICRs describe 

the information we seek to collect from 

the public. Before submitting these ICRs 

to OIRA, the Coast Guard is inviting 

comments as described below. 

DATES: Comments must reach the Coast 

Guard on or before May 18, 2012. 

ADDRESSES: You may submit comments 

identified by Coast Guard docket 

number [USCG–2012–0149] to the 

Docket Management Facility (DMF) at 

the U.S. Department of Transportation 

(DOT). To avoid duplicate submissions, 

please use only one of the following 

means: 

(1) Online: http:// 

www.regulations.gov. 

(2) Mail: DMF (M–30), DOT, West 

Building Ground Floor, Room W12–140, 

1200 New Jersey Avenue SE., 

Washington, DC 20590–0001. 

(3) Hand delivery: Same as mail 

address above, between 9 a.m. and 5 

p.m., Monday through Friday, except 

Federal holidays. The telephone number 

is 202–366–9329. 

(4) Fax: 202–493–2251. To ensure 

your comments are received in a timely 

manner, mark the fax, to attention Desk 

Officer for the Coast Guard. 

The DMF maintains the public docket 

for this Notice. Comments and material 

received from the public, as well as 

documents mentioned in this Notice as 

being available in the docket, will 

become part of the docket and will be 

available for inspection or copying at 

room W12–140 on the West Building 

Ground Floor, 1200 New Jersey Avenue 

SE., Washington, DC, between 9 a.m. 

and 5 p.m., Monday through Friday, 

except Federal holidays. You may also 

find the docket on the Internet at 

http://www.regulations.gov. 

Copies of the ICRs are available 

through the docket on the Internet at 

http://www.regulations.gov. 

Additionally, copies are available from: 

COMMANDANT (CG–611), ATTN 

PAPERWORK REDUCTION ACT 

MANAGER, U.S. COAST GUARD, 2100 

2ND ST SW STOP 7101, 

WASHINGTON, DC 20593–7101. 

FOR FURTHER INFORMATION CONTACT: 

Contact Ms. Kenlinishia Tyler, Office of 

Information Management, telephone 

202–475–3652, or fax 202–475–3929, for 

questions on these documents. Contact 

Ms. Renee V. Wright, Program Manager, 

Docket Operations, 202–366–9826, for 

questions on the docket. 

SUPPLEMENTARY INFORMATION: 

Public Participation and Request for 

Comments 

This Notice relies on the authority of 

the Paperwork Reduction Act of 1995; 

44 U.S.C. Chapter 35, as amended. An 

ICR is an application to OIRA seeking 

the approval, extension, or renewal of a 

Coast Guard collection of information 

(Collection). The ICR contains 

information describing the Collection’s 

purpose, the Collection’s likely burden 

on the affected public, an explanation of 

the necessity of the Collection, and 

other important information describing 

the Collections. There is one ICR for 

each Collection. 

The Coast Guard invites comments on 

whether these ICRs should be granted 

based on the Collections being 

necessary for the proper performance of 

Departmental functions. In particular, 

the Coast Guard would appreciate 

comments addressing: (1) The practical 

utility of the Collections; (2) the 

accuracy of the estimated burden of the 

Collections; (3) ways to enhance the 


emcdonald on DSK29S0YB1PROD with NOTICES