83_FR_14708 83 FR 14642 - Request for Nominations for Board of Governors of the Patient-Centered Outcomes Research Institute (PCORI)

83 FR 14642 - Request for Nominations for Board of Governors of the Patient-Centered Outcomes Research Institute (PCORI)

GOVERNMENT ACCOUNTABILITY OFFICE

Federal Register Volume 83, Issue 66 (April 5, 2018)

Page Range14642-14642
FR Document2018-06999

The Patient Protection and Affordable Care Act gave the Comptroller General of the United States responsibility for appointing 19 members to the Board of Governors of the Patient-Centered Outcomes Research Institute. In addition, the Directors of the Agency for Healthcare Research and Quality and the National Institutes of Health, or their designees, are members of the Board. As the result of terms ending in September 2018, GAO is accepting nominations in the following categories required in statute: A physician, a nurse, a representative of patients and health care consumers, a representative of private payers, a representative of a state or a federal health program or agency, and a representative of pharmaceutical, device, or diagnostic manufacturers or developers. Nominations should be sent to the email or mailing address listed below. Acknowledgement of submissions will be provided within a week of submission.

Federal Register, Volume 83 Issue 66 (Thursday, April 5, 2018) 
[Federal Register Volume 83, Number 66 (Thursday, April 5, 2018)]
[Notices]
[Page 14642]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-06999]


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GOVERNMENT ACCOUNTABILITY OFFICE


Request for Nominations for Board of Governors of the Patient-
Centered Outcomes Research Institute (PCORI)

AGENCY: Government Accountability Office (GAO).

ACTION: Request for letters of nomination and resumes.

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SUMMARY: The Patient Protection and Affordable Care Act gave the 
Comptroller General of the United States responsibility for appointing 
19 members to the Board of Governors of the Patient-Centered Outcomes 
Research Institute. In addition, the Directors of the Agency for 
Healthcare Research and Quality and the National Institutes of Health, 
or their designees, are members of the Board. As the result of terms 
ending in September 2018, GAO is accepting nominations in the following 
categories required in statute: A physician, a nurse, a representative 
of patients and health care consumers, a representative of private 
payers, a representative of a state or a federal health program or 
agency, and a representative of pharmaceutical, device, or diagnostic 
manufacturers or developers. Nominations should be sent to the email or 
mailing address listed below. Acknowledgement of submissions will be 
provided within a week of submission.

DATES: Letters of nomination and resumes should be submitted no later 
than May 4, 2018, to ensure adequate opportunity for review and 
consideration of nominees prior to appointment.

ADDRESSES: Submit letters of nomination and resumes by either of the 
following methods: Email: PCORI@gao.gov. Include PCORI Nominations in 
the subject line of the message, or Mail: U.S. GAO, Attn: PCORI Board 
Nominations, 441 G Street NW, Washington, DC 20548.

FOR FURTHER INFORMATION CONTACT: Rashmi Agarwal at (202) 512-4077 or 
agarwalr@gao.gov if you do not receive an acknowledgement or need 
additional information. For general information, contact GAO's Office 
of Public Affairs, (202) 512-4800.

    Authority:  [Sec. 6301 and Sec. 10602, Pub. L. 111-148].

Gene L. Dodaro,
Comptroller General of the United States.
[FR Doc. 2018-06999 Filed 4-4-18; 8:45 am]
 BILLING CODE 1610-02-P

14642 Federal Register / Vol. 83, No. 66 / Thursday, April 5, 2018 / Notices about the Board, its actions, and the Nominations, 441 G Street NW, instructions for submitting comments. economy. The responses to the FR 3076 Washington, DC 20548. Comments submitted electronically, help the Board determine how to most FOR FURTHER INFORMATION CONTACT: including attachments, to https:// effectively communicate this Rashmi Agarwal at (202) 512–4077 or www.regulations.gov will be posted to information to the public in order to agarwalr@gao.gov if you do not receive the docket unchanged. Because your fulfill its statutory responsibilities. The an acknowledgement or need additional comment will be made public, you are FR 3076 is voluntary. The information information. For general information, solely responsible for ensuring that your collected by the FR 3076 is not contact GAO’s Office of Public Affairs, comment does not include any considered to be confidential. (202) 512–4800. confidential information that you or a Board of Governors of the Federal Reserve third party may not wish to be posted, Authority: [Sec. 6301 and Sec. 10602, Pub. such as medical information, your or System, April 2, 2018. L. 111–148]. Ann Misback, anyone else’s Social Security number, or Gene L. Dodaro, confidential business information, such Secretary of the Board. Comptroller General of the United States. as a manufacturing process. Please note [FR Doc. 2018–06948 Filed 4–4–18; 8:45 am] [FR Doc. 2018–06999 Filed 4–4–18; 8:45 am] that if you include your name, contact BILLING CODE 6210–01–P information, or other information that BILLING CODE 1610–02–P identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. GOVERNMENT ACCOUNTABILITY DEPARTMENT OF HEALTH AND • If you want to submit a comment OFFICE HUMAN SERVICES with confidential information that you Request for Nominations for Board of Food and Drug Administration do not wish to be made available to the Governors of the Patient-Centered public, submit the comment as a [Docket No. FDA–2002–D–0093] written/paper submission and in the Outcomes Research Institute (PCORI) manner detailed (see ‘‘Written/Paper AGENCY: Government Accountability Liposome Drug Products: Chemistry, Submissions’’ and ‘‘Instructions’’). Office (GAO). Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; Written/Paper Submissions ACTION: Request for letters of and Labeling Documentation; Submit written/paper submissions as nomination and resumes. Guidance for Industry; Availability follows: SUMMARY: The Patient Protection and • Mail/Hand delivery/Courier (for AGENCY: Food and Drug Administration, Affordable Care Act gave the written/paper submissions): Dockets HHS. Comptroller General of the United Management Staff (HFA–305), Food and States responsibility for appointing 19 ACTION: Notice of availability. Drug Administration, 5630 Fishers members to the Board of Governors of Lane, Rm. 1061, Rockville, MD 20852. SUMMARY: The Food and Drug the Patient-Centered Outcomes Research • For written/paper comments Administration (FDA or Agency) is Institute. In addition, the Directors of submitted to the Dockets Management announcing the availability of a the Agency for Healthcare Research and Staff, FDA will post your comment, as guidance for industry entitled Quality and the National Institutes of well as any attachments, except for ‘‘Liposome Drug Products: Chemistry, Health, or their designees, are members information submitted, marked and Manufacturing, and Controls; Human of the Board. As the result of terms identified, as confidential, if submitted Pharmacokinetics and Bioavailability; ending in September 2018, GAO is as detailed in ‘‘Instructions.’’ and Labeling Documentation.’’ This Instructions: All submissions received accepting nominations in the following guidance document finalizes the revised categories required in statute: A must include the Docket No. FDA– draft of the same name that published 2002–D–0093 (formerly 2002D–0337) physician, a nurse, a representative of on October 30, 2015. This guidance patients and health care consumers, a for ‘‘Liposome Drug Products: provides recommendations to Chemistry, Manufacturing, and representative of private payers, a applicants on the chemistry, representative of a state or a federal Controls; Human Pharmacokinetics and manufacturing, and controls (CMC); Bioavailability; and Labeling health program or agency, and a pharmacokinetics and bioavailability; representative of pharmaceutical, Documentation.’’ Received comments and labeling documentation for will be placed in the docket and, except device, or diagnostic manufacturers or liposome drug products submitted in developers. Nominations should be sent for those submitted as ‘‘Confidential new drug applications (NDAs) and Submissions,’’ publicly viewable at to the email or mailing address listed abbreviated new drug applications below. Acknowledgement of https://www.regulations.gov or at the (ANDAs), reviewed by the Center for Dockets Management Staff between 9 submissions will be provided within a Drug Evaluation and Research (CDER). week of submission. a.m. and 4 p.m., Monday through DATES: The announcement of the Friday. DATES: Letters of nomination and guidance is published in the Federal • Confidential Submissions—To resumes should be submitted no later Register on April 5, 2018. submit a comment with confidential than May 4, 2018, to ensure adequate information that you do not wish to be ADDRESSES: You may submit either opportunity for review and made publicly available, submit your electronic or written comments on consideration of nominees prior to comments only as a written/paper Agency guidances at any time as appointment. amozie on DSK30RV082PROD with NOTICES follows: submission. You should submit two ADDRESSES: Submit letters of copies total. One copy will include the nomination and resumes by either of the Electronic Submissions information you claim to be confidential following methods: Email: PCORI@ Submit electronic comments in the with a heading or cover note that states gao.gov. Include PCORI Nominations in following way: ‘‘THIS DOCUMENT CONTAINS the subject line of the message, or Mail: • Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The U.S. GAO, Attn: PCORI Board https://www.regulations.gov. Follow the Agency will review this copy, including VerDate Sep<11>2014 18:33 Apr 04, 2018 Jkt 244001 PO 00000 Frm 00021 Fmt 4703 Sfmt 4703 E:\FR\FM\05APN1.SGM 05APN1


Document Created: 2018-11-01 09:13:04
Document Modified: 2018-11-01 09:13:04
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionRequest for letters of nomination and resumes.
DatesLetters of nomination and resumes should be submitted no later than May 4, 2018, to ensure adequate opportunity for review and consideration of nominees prior to appointment.
ContactRashmi Agarwal at (202) 512-4077 or [email protected] if you do not receive an acknowledgement or need additional information. For general information, contact GAO's Office of Public Affairs, (202) 512-4800.
FR Citation83 FR 14642 
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