Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request, 31947-31949 [2016-11869]

Download as PDF Federal Register / Vol. 81, No. 98 / Friday, May 20, 2016 / Notices The meeting will be held on June 20, 2016, from 9:30 a.m. to 1 p.m. ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD, 20993–0002. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: http://www.fda.gov/ AdvisoryCommittees/AboutAdvisory Committees/ucm408555.htm. For those unable to attend in person, the meeting will also be Webcast and will be available at the following link: https:// collaboration.fda.gov/bpac2016/. FOR FURTHER INFORMATION CONTACT: Bryan Emery or Joanne Lipkind, Division of Scientific Advisors and Consultants, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6132, Silver Spring, MD 20993–0002, 240– 402–8054, bryan.emery@fda.hhs.gov, and 240–402–8106, joanne.lipkind@ fda.hhs.gov, respectively; or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency’s Web site at http://www.fda. gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. SUPPLEMENTARY INFORMATION: Agenda: On June 20, 2016, the Committee members will participate in the meeting via teleconference. In open session, the Committee will discuss the research programs in the Laboratory of Plasma Derivatives in the Division of Hematology Research and Review, Office of Blood Research and Review, Center for Biologics Evaluation and Research, FDA. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at http://www.fda.gov/ AdvisoryCommittees/Calendar/ mstockstill on DSK3G9T082PROD with NOTICES DATES: VerDate Sep<11>2014 17:40 May 19, 2016 Jkt 238001 default.htm. Scroll down to the appropriate advisory committee meeting link. Procedure: On June 20, 2016, from 9:30 a.m. to 12:20 p.m., the meeting is open to the public. Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before June 6, 2016. Oral presentations from the public will be scheduled between approximately 11:20 a.m. to 12:20 p.m. on June 20, 2016. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before June 3, 2016. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by June 6, 2016. Closed Committee Deliberations: On June 20, 2016, from 12:20 p.m. to 1 p.m., the meeting will be closed to the public to permit discussion where disclosure would constitute a clearly unwarranted invasion of personal privacy (5 U.S.C. 552b(c)(6)). The Committee will discuss the site visit report of the intramural research programs and make recommendations regarding personnel staffing decisions. Persons attending FDA’s advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Bryan Emery at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at http://www.fda.gov/Advisory Committees/AboutAdvisoryCommittees/ ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 31947 Dated: May 16, 2016. Jill Hartzler Warner, Associate Commissioner for Special Medical Programs. [FR Doc. 2016–11854 Filed 5–19–16; 8:45 am] BILLING CODE 4164–01–P 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 Health Resources and Services Administration, HHS. ACTION: Notice. AGENCY: 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 OIRA_ submission@omb.eop.gov 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 paperwork@hrsa.gov or call (301) 443–1984. SUPPLEMENTARY INFORMATION: When submitting comments or requesting information, please include the information request collection title for reference. SUMMARY: 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 E:\FR\FM\20MYN1.SGM 20MYN1 31948 Federal Register / Vol. 81, No. 98 / Friday, May 20, 2016 / Notices 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. mstockstill on DSK3G9T082PROD with NOTICES TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS Number of respondents Form name Number of responses per respondent Total responses Average burden per response (in hours) Total burden hours Audits Resolution 1 Good faith ........................................................ Audit Notification to Entity 1 ................................................. VerDate Sep<11>2014 17:40 May 19, 2016 Jkt 238001 PO 00000 Frm 00040 10 10 Fmt 4703 Sfmt 4703 1 1 E:\FR\FM\20MYN1.SGM 10 10 20MYN1 60 6 600 60 31949 Federal Register / Vol. 81, No. 98 / Friday, May 20, 2016 / Notices TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS—Continued Number of respondents Form name Audit Workplan 1 .................................................................. Audit Report 1 ....................................................................... Entity Response ................................................................... Number of responses per respondent 40 8 8 Average burden per response (in hours) Total responses Total burden hours 1 1 1 18 8 8 12 12 12 216 96 96 4 1 ........................ 40 10 104 15 28 ........................ 600 280 1948 Recordkeeping requirement Number of recordkeepers Hours of recordkeeping Total burden Dispute Records .......................................................................................................................... 50 1 50 Dispute Resolution Dispute Request .................................................................. Rebuttal ................................................................................ Total .............................................................................. 1 Prepared 10 10 96 by the manufacturer. Recordkeeping Burden: 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Maternal and Child Health Collaborative Office Rounds Health Resources and Services Administration, HHS. ACTION: Notice of a class deviation from competition requirements for Maternal and Child Health Collaborative Office Rounds. AGENCY: HRSA announces the award of an extension in the amount of $150,000 for the Maternal and Child Health Collaborative Office Rounds SUMMARY: (MCH–COR) grants. The purpose of the program is to foster joint pediatricschild psychiatry continuing education in the psychosocial development aspects of child health, utilizing a study group approach that emphasizes the practical challenges confronted by community based practitioners. The extension will permit recipients to continue activities within the scope of the current award while the program is evaluated, during the budget period of 7/1/2016–6/30/2017. FOR FURTHER INFORMATION CONTACT: Rita Maldonado, Division of Maternal Child Health Workforce Development, Maternal and Child Health Bureau, Health Resources and Services Administration, 5600 Fishers Lane, Room 18W13A, Rockville, MD 20852, Phone: 301.443.3622, Email: RMaldonado@hrsa.gov. SUPPLEMENTARY INFORMATION: Intended Recipient of the Award: Children’s Research Institute, Johns mstockstill on DSK3G9T082PROD with NOTICES Authority: Social Security Act, Title V, Section 502(a)(1) Justification: MCHB is requesting a one-time extension to continue activities while the program is evaluated to determine future activities using the COR model. MCHB will evaluate the basic structure of the COR model, identify gaps, and propose possible enhancements to the model. Revised project end date FY 2015 authorized funding level FY 2016 estimated funding level Current project end date DC 7/1/2011 6/30/2016 6/30/2017 $15,000 $15,000 T20MC07472 T20MC07464 T20MC21951 OH MD NY 7/1/2011 7/1/2011 7/1/2011 6/30/2016 6/30/2016 6/30/2016 6/30/2017 6/30/2017 6/30/2017 15,000 15,000 14,999 15,000 15,000 14,999 T20MC07469 MN 7/1/2011 6/30/2016 6/30/2017 15,000 15,000 T20MC21952 CA 7/1/2011 6/30/2016 6/30/2017 15,000 15,000 T20MC07463 MI 7/1/2011 6/30/2016 6/30/2017 15,000 15,000 T20MC07473 NH 7/1/2011 6/30/2016 6/30/2017 15,000 15,000 T20MC25634 IL 7/1/2011 6/30/2016 6/30/2017 14,859 14,859 Grant No. CHILDREN’S RESEARCH INSTITUTE. Children’s Research Institute ...... JOHNS HOPKINS UNIVERSITY NEW YORK UNIVERSITY SCHOOL OF MEDICINE. Regents of the University of Minnesota. The Regents of the University of California, San Francisco. THE REGENTS OF THE UNIVERSITY OF MICHIGAN. TRUSTEES OF DARTMOUTH COLLEGE. UNIVERSITY OF ILLINOIS ......... T20MC21950 17:40 May 19, 2016 CFDA Number: 93.110 Current project start date Grant recipient/organization name VerDate Sep<11>2014 Hopkins University, New York School of Medicine, Regents of the University of Minnesota, The Regents of the University of California, San Francisco. The Regents of the University of Michigan, Trustees of Dartmouth College, University of Illinois, Yale University. Amount of Each Non-Competitive Awards: $15,000. Period of Supplemental Funding: 7/1/ 2016–6/30/2017. Jkt 238001 State PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 E:\FR\FM\20MYN1.SGM 20MYN1

Agencies

[Federal Register Volume 81, Number 98 (Friday, May 20, 2016)]
[Notices]
[Pages 31947-31949]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 
OIRA_submission@omb.eop.gov 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 paperwork@hrsa.gov 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