Public Hearing, 16043-16044 [2012-6567]

Download as PDF 16043 Federal Register / Vol. 77, No. 53 / Monday, March 19, 2012 / Notices 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 Number of respondents Reporting requirement Responses per respondent 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: Total responses Hours per response Total burden hours Hospital Enrollment, Additions & Recertifications 340B Program Registrations & Certifications for Hospitals Certifications to Enroll Hospital Outpatient Facilities ........... Hospital Annual Recertifications .......................................... 546 606 4842 1 1 1 546 606 4842 2.0 .50 .50 1092 303 2421 Registrations and Recertifications for Entities Other Than Hospitals 340B Registrations for Community Health Centers ............ 340B Registrations for Family Planning Programs, STD/TB Clinics and Various Other Eligible Entity Types .............. Community Health Center Annual Recertifications ............. Family Planning Annual Recertifications ............................. STD & TB Annual Recertifications ...................................... Annual Recertification for Entities other than Hospitals, Community Health Centers, Family Planning, STD or TB Clinics ............................................................................... 253 1 253 1.0 253 353 4507 3879 2754 1 1 1 1 353 4507 3879 2754 1.0 .50 .50 .50 353 2253.5 1939.5 1377 1174 1 1174 .50 587 2500 1 2500 .50 1250 350 1 350 .50 175 2500 24,264 1.0 ........................ 2500 14,504 Other Information Collections Submission of Administrative Changes for any Covered Entity ................................................................................. Submission of Administrative Changes for any Manufacturer .................................................................................. Contracted Pharmacy Services Registration & Recertifications emcdonald on DSK29S0YB1PROD with NOTICES Contracted Pharmacy Services Registration ....................... Total .............................................................................. 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. VerDate Mar<15>2010 13:40 Mar 16, 2012 Jkt 226001 2500 24,264 1 ........................ 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 PO 00000 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Public Hearing 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 SUMMARY: Frm 00050 Fmt 4703 Sfmt 4703 E:\FR\FM\19MRN1.SGM 19MRN1 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: https://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 emcdonald on DSK29S0YB1PROD with NOTICES 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, VerDate Mar<15>2010 13:40 Mar 16, 2012 Jkt 226001 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. Coast Guard, DHS. Sixty-day notice requesting comments. AGENCY: ACTION: 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: https:// 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. SUMMARY: PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 (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 https://www.regulations.gov. Copies of the ICRs are available through the docket on the Internet at https://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 E:\FR\FM\19MRN1.SGM 19MRN1

Agencies

[Federal Register Volume 77, Number 53 (Monday, March 19, 2012)]
[Notices]
[Pages 16043-16044]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-6567]


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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

[[Page 16044]]

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: https://nihblueribbonpanel-bumc-neidl.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
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