81 FR 31947 - Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration Federal Register Volume 81, Issue 98 (May 20, 2016)
Health Resources and Services Administration
Federal Register Volume 81, Issue 98 (May 20, 2016)
| Page Range | 31947-31949 | |
| FR Document | 2016-11869 |
[Federal Register Volume 81, Number 98 (Friday, May 20, 2016)] [Notices] [Pages 31947-31949] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-11869] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request AGENCY: Health Resources and Services Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. DATES: Comments on this ICR should be received no later than June 20, 2016. ADDRESSES: Submit your comments, including the Information Collection Request Title, to the desk officer for HRSA, either by email to [email protected] or by fax to 202-395-5806. FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance requests submitted to OMB for review, email the HRSA Information Collection Clearance Officer at [email protected] or call (301) 443- 1984. SUPPLEMENTARY INFORMATION: When submitting comments or requesting information, please include the information request collection title for reference. Information Collection Request Title: 340B Drug Pricing Program Reporting Requirements OMB No. 0915-0176--[Revision] Abstract: 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 participates in Medicaid must sign a Pharmaceutical Pricing Agreement with [[Page 31948]] the Secretary of Health and Human Services in which the manufacturer agrees to charge enrolled covered entities a price for covered outpatient drugs that will not exceed an amount determined under a statutory formula. Covered entities who 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 requesting Medicaid reimbursement from a drug that has been discounted under the 340B Program. 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. Section 340B(a)(5)(C) of the PHS Act permits the Secretary and manufacturers of a covered outpatient drug to conduct audits of covered entities in accordance with procedures established by the Secretary related to the number, duration, and scope of the audits. Manufacturers are permitted to conduct an audit only when there is reasonable cause to believe a violation of section 340B(a)(5)(A) or (B) has occurred. The manufacturer notifies the covered entity in writing when it believes the covered entity has violated these provisions of the 340B Program. If the problem cannot be resolved, the manufacturer will then submit an audit work plan describing the audit and evidence in support of the reasonable cause standard to HRSA, Healthcare Systems Bureau, Office of Pharmacy Affairs (OPA) for review. OPA will review the documentation to determine if reasonable cause exists. Once the audit is complete, the manufacturer will submit copies of the audit report to OPA for review and resolution of the findings, as appropriate. The manufacturer will also submit an informational copy of the audit report to the Health and Human Services (HHS) Office of Inspector General (OIG). In response to the statutory mandate of section 340B(a)(5)(C) to permit the Secretary or manufacturers to conduct audits of covered entities and because of the potential for disputes involving covered entities and participating drug manufacturers, OPA developed an informal voluntary dispute resolution process for manufacturers and covered entities who, prior to filing a request for resolution of a dispute with OPA, should attempt in good faith to resolve the dispute. All parties involved in the dispute should maintain written documentation as evidence of a good faith attempt to resolve the dispute. To request voluntary dispute resolution of an unresolved dispute, a party submits a written request for a review of the dispute to OPA. A committee appointed to review the documentation will send a letter to the party alleged to have committed a violation. The party will be asked to provide a response to or a rebuttal of the allegations. HRSA published a notice in 1996 and a policy release in 2011 on manufacturer audit guidelines and the informal dispute resolution process (61 FR 65406 (December 12, 1996) and ``Clarification of Manufacturer Audits of 340B Covered Entities,'' Release No. 2011-3). The revision to this package includes additional background information on the dispute resolution process and clarifies the need and proposed use of information regarding the manufacturer audit guidelines and the informal dispute resolution process. HHS has reviewed all comments submitted in response to the publication of a 60-day Federal Register notice requesting comments on this ICR. Comments submitted included requests for standardized reporting forms. Commenters also expressed concern that burden hours were significantly understated. HHS agrees that the burdens associated with this ICR may have been understated. Adjusted burden estimates are included in this 30-day notice. Finally, HHS appreciates the comments received regarding the development of a formal dispute resolution process. HHS is in the process of developing a regulation to establish and implement a binding administrative dispute resolution process pursuant to section 340(d)(3) of the PHS Act. Some of the comments received regarding the audit process are beyond the scope of this notice, and as such, HHS will not be addressing them in this notice. Need and Proposed Use of the Information: HRSA is proposing the collection of information related to the manufacturer audit guidelines. These guidelines contain the following reporting/notification elements: 1. Manufacturers should notify the entity in writing when it believes a violation has occurred; 2. manufacturers should submit documentation to OPA as evidence of good faith of attempts to resolve a dispute; 3. manufacturers must submit an audit work plan to OPA; 4. manufacturers should submit the audit report to OPA and informational copies to the HHS OIG; and 5. the covered entity should provide a written response to the audit report. This information is necessary to ensure the orderly conduct of manufacturer audits. In addition, the informal dispute resolution process requires the participating manufacturer or covered entity requesting dispute resolution to provide OPA with a written request. The party alleged to have committed a section 340B violation may provide a response or rebuttal to OPA. This information is necessary to ensure that the dispute will be resolved in a fair and equitable manner. Likely Respondents: Drug manufacturers and 340B covered entities. Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose or provide the information requested. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information; to search data sources; to complete and review the collection of information; and to transmit or otherwise disclose the information. The total annual burden hours estimated for this ICR are summarized in the table below. Total Estimated Annualized Burden--Hours ---------------------------------------------------------------------------------------------------------------- Number of Average burden Form name Number of responses per Total per response Total burden respondents respondent responses (in hours) hours ---------------------------------------------------------------------------------------------------------------- Audits ---------------------------------------------------------------------------------------------------------------- Good faith Resolution \1\....... 10 1 10 60 600 Audit Notification to Entity \1\ 10 1 10 6 60 [[Page 31949]] Audit Workplan \1\.............. 40 1 18 12 216 Audit Report \1\................ 8 1 8 12 96 Entity Response................. 8 1 8 12 96 ---------------------------------------------------------------------------------------------------------------- Dispute Resolution ---------------------------------------------------------------------------------------------------------------- Dispute Request................. 10 4 40 15 600 Rebuttal........................ 10 1 10 28 280 Total....................... 96 .............. 104 .............. 1948 ---------------------------------------------------------------------------------------------------------------- \1\ Prepared by the manufacturer. Recordkeeping Burden: ---------------------------------------------------------------------------------------------------------------- Number of Hours of Recordkeeping requirement recordkeepers recordkeeping Total burden ---------------------------------------------------------------------------------------------------------------- Dispute Records.............................................. 50 1 50 ---------------------------------------------------------------------------------------------------------------- Jason E. Bennett, Director, Division of the Executive Secretariat. [FR Doc. 2016-11869 Filed 5-19-16; 8:45 am] BILLING CODE 4165-15-P
![Federal Register / Vol. 81, No. 98 / Friday, May 20, 2016 / Notices 31947
DATES: The meeting will be held on June default.htm. Scroll down to the Dated: May 16, 2016.
20, 2016, from 9:30 a.m. to 1 p.m. appropriate advisory committee meeting Jill Hartzler Warner,
ADDRESSES: FDA White Oak Campus, link. Associate Commissioner for Special Medical
10903 New Hampshire Ave., Bldg. 31 Procedure: On June 20, 2016, from Programs.
Conference Center, the Great Room (Rm. 9:30 a.m. to 12:20 p.m., the meeting is [FR Doc. 2016–11854 Filed 5–19–16; 8:45 am]
1503), Silver Spring, MD, 20993–0002. open to the public. Interested persons BILLING CODE 4164–01–P
Answers to commonly asked questions may present data, information, or views,
including information regarding special orally or in writing, on issues pending
accommodations due to a disability, before the committee. Written DEPARTMENT OF HEALTH AND
visitor parking, and transportation may submissions may be made to the contact HUMAN SERVICES
be accessed at: http://www.fda.gov/ person on or before June 6, 2016. Oral
AdvisoryCommittees/AboutAdvisory presentations from the public will be Health Resources and Services
Committees/ucm408555.htm. For those scheduled between approximately 11:20 Administration
unable to attend in person, the meeting a.m. to 12:20 p.m. on June 20, 2016.
Those individuals interested in making Agency Information Collection
will also be Webcast and will be
formal oral presentations should notify Activities: Submission to OMB for
available at the following link: https://
the contact person and submit a brief Review and Approval; Public Comment
collaboration.fda.gov/bpac2016/.
statement of the general nature of the Request
FOR FURTHER INFORMATION CONTACT:
Bryan Emery or Joanne Lipkind, evidence or arguments they wish to AGENCY: Health Resources and Services
Division of Scientific Advisors and present, the names and addresses of Administration, HHS.
Consultants, Center for Biologics proposed participants, and an ACTION: Notice.
Evaluation and Research, Food and indication of the approximate time
Drug Administration, 10903 New requested to make their presentation on SUMMARY: In compliance with Section
Hampshire Ave., Bldg. 71, Rm. 6132, or before June 3, 2016. Time allotted for 3507(a)(1)(D) of the Paperwork
Silver Spring, MD 20993–0002, 240– each presentation may be limited. If the Reduction Act of 1995, the Health
402–8054, bryan.emery@fda.hhs.gov, number of registrants requesting to Resources and Services Administration
and 240–402–8106, joanne.lipkind@ speak is greater than can be reasonably (HRSA) has submitted an Information
fda.hhs.gov, respectively; or FDA accommodated during the scheduled Collection Request (ICR) to the Office of
Advisory Committee Information Line, open public hearing session, FDA may Management and Budget (OMB) for
1–800–741–8138 (301–443–0572 in the conduct a lottery to determine the review and approval. Comments
Washington, DC area). A notice in the speakers for the scheduled open public submitted during the first public review
Federal Register about last minute hearing session. The contact person will of this ICR will be provided to OMB.
modifications that impact a previously notify interested persons regarding their OMB will accept further comments from
announced advisory committee meeting request to speak by June 6, 2016. the public during the review and
cannot always be published quickly Closed Committee Deliberations: On approval period.
enough to provide timely notice. June 20, 2016, from 12:20 p.m. to 1 p.m., DATES: Comments on this ICR should be
Therefore, you should always check the the meeting will be closed to the public received no later than June 20, 2016.
Agency’s Web site at http://www.fda. to permit discussion where disclosure ADDRESSES: Submit your comments,
gov/AdvisoryCommittees/default.htm would constitute a clearly unwarranted including the Information Collection
and scroll down to the appropriate invasion of personal privacy (5 U.S.C. Request Title, to the desk officer for
advisory committee meeting link, or call 552b(c)(6)). The Committee will discuss HRSA, either by email to OIRA_
the advisory committee information line the site visit report of the intramural submission@omb.eop.gov or by fax to
to learn about possible modifications research programs and make 202–395–5806.
before coming to the meeting. recommendations regarding personnel FOR FURTHER INFORMATION CONTACT: To
SUPPLEMENTARY INFORMATION: staffing decisions. request a copy of the clearance requests
Agenda: On June 20, 2016, the Persons attending FDA’s advisory submitted to OMB for review, email the
Committee members will participate in committee meetings are advised that the HRSA Information Collection Clearance
the meeting via teleconference. In open Agency is not responsible for providing Officer at paperwork@hrsa.gov or call
session, the Committee will discuss the access to electrical outlets. (301) 443–1984.
research programs in the Laboratory of FDA welcomes the attendance of the SUPPLEMENTARY INFORMATION: When
Plasma Derivatives in the Division of public at its advisory committee submitting comments or requesting
Hematology Research and Review, meetings and will make every effort to information, please include the
Office of Blood Research and Review, accommodate persons with disabilities. information request collection title for
Center for Biologics Evaluation and If you require accommodations due to a reference.
Research, FDA. disability, please contact Bryan Emery
FDA intends to make background at least 7 days in advance of the Information Collection Request Title:
material available to the public no later meeting. 340B Drug Pricing Program Reporting
than 2 business days before the meeting. FDA is committed to the orderly Requirements OMB No. 0915–0176—
If FDA is unable to post the background conduct of its advisory committee [Revision]
material on its Web site prior to the meetings. Please visit our Web site at Abstract: Section 602 of Public Law
meeting, the background material will http://www.fda.gov/Advisory 102–585, the Veterans Health Care Act
mstockstill on DSK3G9T082PROD with NOTICES
be made publicly available at the Committees/AboutAdvisoryCommittees/ of 1992, enacted section 340B of the
location of the advisory committee ucm111462.htm for procedures on Public Health Service Act (PHS Act)
meeting, and the background material public conduct during advisory ‘‘Limitation on Prices of Drugs
will be posted on FDA’s Web site after committee meetings. Purchased by Covered Entities.’’ Section
the meeting. Background material is Notice of this meeting is given under 340B provides that a manufacturer who
available at http://www.fda.gov/ the Federal Advisory Committee Act (5 participates in Medicaid must sign a
AdvisoryCommittees/Calendar/ U.S.C. app. 2). Pharmaceutical Pricing Agreement with
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![Federal Register / Vol. 81, No. 98 / Friday, May 20, 2016 / Notices 31949
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS—Continued
Average
Number of
Number of Total burden per Total burden
Form name responses per
respondents responses response hours
respondent (in hours)
Audit Workplan 1 .................................................................. 40 1 18 12 216
Audit Report 1 ....................................................................... 8 1 8 12 96
Entity Response ................................................................... 8 1 8 12 96
Dispute Resolution
Dispute Request .................................................................. 10 4 40 15 600
Rebuttal ................................................................................ 10 1 10 28 280
Total .............................................................................. 96 ........................ 104 ........................ 1948
1 Prepared by the manufacturer.
Recordkeeping Burden:
Number of Hours of
Recordkeeping requirement Total burden
recordkeepers recordkeeping
Dispute Records .......................................................................................................................... 50 1 50
Jason E. Bennett, (MCH–COR) grants. The purpose of the Hopkins University, New York School
Director, Division of the Executive Secretariat. program is to foster joint pediatrics- of Medicine, Regents of the University
[FR Doc. 2016–11869 Filed 5–19–16; 8:45 am] child psychiatry continuing education of Minnesota, The Regents of the
BILLING CODE 4165–15–P in the psychosocial development University of California, San Francisco.
aspects of child health, utilizing a study The Regents of the University of
group approach that emphasizes the Michigan, Trustees of Dartmouth
DEPARTMENT OF HEALTH AND practical challenges confronted by College, University of Illinois, Yale
HUMAN SERVICES community based practitioners. The University.
extension will permit recipients to Amount of Each Non-Competitive
Health Resources and Services continue activities within the scope of Awards: $15,000.
Administration the current award while the program is
evaluated, during the budget period of Period of Supplemental Funding: 7/1/
Maternal and Child Health 7/1/2016–6/30/2017. 2016–6/30/2017.
Collaborative Office Rounds FOR FURTHER INFORMATION CONTACT: Rita CFDA Number: 93.110
AGENCY: Health Resources and Services Maldonado, Division of Maternal Child
Authority: Social Security Act, Title V,
Administration, HHS. Health Workforce Development,
Section 502(a)(1)
ACTION: Notice of a class deviation from
Maternal and Child Health Bureau,
Health Resources and Services Justification: MCHB is requesting a
competition requirements for Maternal
Administration, 5600 Fishers Lane, one-time extension to continue
and Child Health Collaborative Office
Room 18W13A, Rockville, MD 20852, activities while the program is evaluated
Rounds.
Phone: 301.443.3622, Email: to determine future activities using the
SUMMARY: HRSA announces the award RMaldonado@hrsa.gov. COR model. MCHB will evaluate the
of an extension in the amount of SUPPLEMENTARY INFORMATION: basic structure of the COR model,
$150,000 for the Maternal and Child Intended Recipient of the Award: identify gaps, and propose possible
Health Collaborative Office Rounds Children’s Research Institute, Johns enhancements to the model.
Revised FY 2015 FY 2016
Current project Current project
Grant recipient/organization name Grant No. State project end authorized estimated
start date end date date funding level funding level
CHILDREN’S RESEARCH INSTI- T20MC21950 DC 7/1/2011 6/30/2016 6/30/2017 $15,000 $15,000
TUTE.
Children’s Research Institute ...... T20MC07472 OH 7/1/2011 6/30/2016 6/30/2017 15,000 15,000
JOHNS HOPKINS UNIVERSITY T20MC07464 MD 7/1/2011 6/30/2016 6/30/2017 15,000 15,000
NEW YORK UNIVERSITY T20MC21951 NY 7/1/2011 6/30/2016 6/30/2017 14,999 14,999
SCHOOL OF MEDICINE.
Regents of the University of Min- T20MC07469 MN 7/1/2011 6/30/2016 6/30/2017 15,000 15,000
mstockstill on DSK3G9T082PROD with NOTICES
nesota.
The Regents of the University of T20MC21952 CA 7/1/2011 6/30/2016 6/30/2017 15,000 15,000
California, San Francisco.
THE REGENTS OF THE UNI- T20MC07463 MI 7/1/2011 6/30/2016 6/30/2017 15,000 15,000
VERSITY OF MICHIGAN.
TRUSTEES OF DARTMOUTH T20MC07473 NH 7/1/2011 6/30/2016 6/30/2017 15,000 15,000
COLLEGE.
UNIVERSITY OF ILLINOIS ......... T20MC25634 IL 7/1/2011 6/30/2016 6/30/2017 14,859 14,859
VerDate Sep<11>2014 17:40 May 19, 2016 Jkt 238001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 E:\FR\FM\20MYN1.SGM 20MYN1](https://thefederalregister.org/doc/81_FR_32045/page/3.svg)
Document Created: 2016-05-20 02:00:05
Document Modified: 2016-05-20 02:00:05
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Comments on this ICR should be received no later than June 20, 2016. | |
| Contact | To request a copy of the clearance requests submitted to OMB for review, email the HRSA Information Collection Clearance Officer at [email protected] or call (301) 443- 1984. | |
| FR Citation | 81 FR 31947 |
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