82_FR_37385 82 FR 37233 - Meetings Announcement for the Physician-Focused Payment Model Technical Advisory Committee Required by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA)

82 FR 37233 - Meetings Announcement for the Physician-Focused Payment Model Technical Advisory Committee Required by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA)

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 82, Issue 152 (August 9, 2017)

Page Range37233-37234
FR Document2017-16784

This notice announces the next meeting of the Physician- Focused Payment Model Technical Advisory Committee (hereafter referred to as ``the Committee'') which will be held in Washington, DC. This meeting will include voting and deliberations on proposals for physician-focused payment models (PFPMs) submitted by members of the public. All meetings are open to the public.

Federal Register, Volume 82 Issue 152 (Wednesday, August 9, 2017) 
[Federal Register Volume 82, Number 152 (Wednesday, August 9, 2017)]
[Notices]
[Pages 37233-37234]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-16784]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Meetings Announcement for the Physician-Focused Payment Model 
Technical Advisory Committee Required by the Medicare Access and CHIP 
Reauthorization Act of 2015 (MACRA)

ACTION: Notice of public meetings.

-----------------------------------------------------------------------

SUMMARY: This notice announces the next meeting of the Physician-
Focused Payment Model Technical Advisory Committee (hereafter referred 
to as ``the Committee'') which will be held in Washington, DC. This 
meeting will include voting and deliberations on proposals for 
physician-focused payment models (PFPMs) submitted by members of the 
public. All meetings are open to the public.

DATES: The PTAC meeting will occur on the following dates:
     Thursday--Friday, September 7-8, 2017, from 9:00 a.m. to 
5:00 p.m. ET.
    Please note that times are subject to change. If the times change, 
registrants will be notified directly via email.

ADDRESSES: The September 7-8, 2017 meeting will be held at the Hubert 
H. Humphrey Building, 200 Independence Avenue SW., Washington, DC, 
20201.

FOR FURTHER INFORMATION CONTACT: Ann Page, Designated Federal Official, 
at the Office of Health Policy, Assistant Secretary for Planning and 
Evaluation, U.S. Department of Health and Human Services, 200 
Independence Ave. SW., Washington, DC 20201, (202) 690-6870.

SUPPLEMENTARY INFORMATION:

I. Purpose

    The Physician-Focused Payment Model Technical Advisory Committee 
(``the Committee'') is required by the

[[Page 37234]]

Medicare Access and CHIP Reauthorization Act of 2015, 42 U.S.C 1395ee. 
This Committee is also governed by provisions of the Federal Advisory 
Committee Act, as amended (5 U.S.C App.), which sets forth standards 
for the formation and use of federal advisory committees. In accordance 
with its statutory mandate, the Committee is to review physician-
focused payment model proposals and prepare recommendations regarding 
whether such models meet criteria that were established through 
rulemaking by the Secretary of Health and Human Services (the 
Secretary). The Committee is composed of 11 members appointed by the 
Comptroller General.

II. Agenda

    At the September 7-8, 2017, the Committee will hear presentations 
on PFPMs that are ready for Committee deliberation. The presentations 
will be followed by public comment and Committee deliberation. If the 
Committee completes deliberations, voting will occur on recommendations 
to the Secretary of Health and Human Services. There will be time 
allocated for public comment on agenda items. Documents will be posted 
on the Committee Web site and distributed on the Committee listserv 
prior to the public meeting. The agenda is subject to change. If the 
agenda does change, we will inform registrants and update our Web site 
to reflect any changes.

III. Meeting Attendance

    The meeting is open to the public. The public may also attend via 
conference call or view the meeting via livestream at www.hhs.gov/live. 
The conference call dial-in information will be sent to registrants 
prior to the meeting.

Meeting Registration

    The public may attend the meetings in-person or participate by 
phone via audio teleconference. Space is limited and registration is 
preferred in order to attend in-person or by phone. Registration may be 
completed online at www.regonline.com/PTACMeetingsRegistration.
    The following information is submitted when registering:

Name:
Company/organization name:
Postal address:
Email address:

    Persons wishing to attend this meeting must register by following 
the instructions in the ``Meeting Registration'' section of this 
notice. A confirmation email will be sent to registrants shortly after 
completing the registration process.

IV. Special Accommodations

    If sign language interpretation or other reasonable accommodation 
for a disability is needed, please contact Angela Tejeda, no later than 
August 24, 2017. Please submit your requests by email to 
[email protected] or by calling 202-401-8297.

V. Copies of the PTAC Charter and Meeting Material

    The Secretary's Charter for the Physician-Focused Payment Model 
Technical Advisory Committee is available on the ASPE Web site at 
https://aspe.hhs.gov/charter-physician-focused-payment-model-technical-advisory-committee.
    Additional material for this meeting can be found on the PTAC Web 
site. For updates and announcements, please use the link to subscribe 
to the PTAC email listserv.

    Dated: August 3, 2017.
John R. Graham,
Acting Assistant Secretary for Planning and Evaluation.
[FR Doc. 2017-16784 Filed 8-8-17; 8:45 am]
 BILLING CODE 4150-05-P

Federal Register / Vol. 82, No. 152 / Wednesday, August 9, 2017 / Notices 37233 contact information to be made publicly and Cosmetic Act (the FD&C Act) (21 approved under OMB control number available, you can provide this U.S.C. 356a) and 21 CFR 601.12. Section 0910–0338. information on the cover sheet and not 506A of the FD&C Act provides III. Electronic Access in the body of your comments and you requirements for making and reporting must identify this information as manufacturing changes to an approved Persons with access to the internet ‘‘confidential.’’ Any information marked application or license and for may obtain the draft guidance at either as ‘‘confidential’’ will not be disclosed distributing a drug product made with http://www.fda.gov/Drugs/Guidance except in accordance with 21 CFR 10.20 such changes. Under § 601.12, each ComplianceRegulatoryInformation/ and other applicable disclosure law. For post-approval change in the product, Guidances/default.htm, http:// more information about FDA’s posting production process, quality controls, www.fda.gov/BiologicsBloodVaccines/ of comments to public dockets, see 80 equipment, facilities, or responsible GuidanceComplianceRegulatory FR 56469, September 18, 2015, or access personnel established in an approved Information/default.htm, or https:// the information at: https://www.gpo.gov/ BLA is categorized into one of three www.regulations.gov. fdsys/pkg/FR-2015-09-18/pdf/2015- reporting categories: Dated: August 3, 2017. 23389.pdf. • Major change: Applicants must Anna K. Abram, Docket: For access to the docket to submit and receive FDA’s approval of a supplement to the BLA before the Deputy Commissioner for Policy, Planning, read background documents or the Legislation, and Analysis. electronic and written/paper comments product produced with the [FR Doc. 2017–16718 Filed 8–8–17; 8:45 am] received, go to https://www.regulations manufacturing change is distributed. .gov and insert the docket number, • Moderate change: Applicants must BILLING CODE 4164–01–P found in brackets in the heading of this submit a supplement at least 30 days document, into the ‘‘Search’’ box and before the product is distributed or, in some cases, the product may be DEPARTMENT OF HEALTH AND follow the prompts and/or go to the HUMAN SERVICES Dockets Management Staff, 5630 Fishers distributed immediately upon FDA’s Lane, Rm. 1061, Rockville, MD 20852. receipt of the supplement. • Minor change: Applicants may Meetings Announcement for the Submit written requests for single Physician-Focused Payment Model copies of the draft guidance to the proceed with the change but must notify FDA of the change in an annual report. Technical Advisory Committee Division of Drug Information, Center for Required by the Medicare Access and This draft guidance provides Drug Evaluation and Research, Food CHIP Reauthorization Act of 2015 recommendations for changes that and Drug Administration, 10001 New (MACRA) generally should be documented in an Hampshire Ave., Hillandale Building, annual report. It discusses the contents ACTION: Notice of public meetings. 4th Floor, Silver Spring, MD 20993– of an annual report notification and lists 0002 or to the Office of Communication, examples of postapproval SUMMARY: This notice announces the Outreach and Development, Center for manufacturing changes for BLAs that next meeting of the Physician-Focused Biologics Evaluation and Research, FDA generally considers to have a Payment Model Technical Advisory Food and Drug Administration, 10903 minimal potential to have an adverse Committee (hereafter referred to as ‘‘the New Hampshire Ave., Bldg. 71, Rm. effect on the identity, strength, quality, Committee’’) which will be held in 3128, Silver Spring, MD 20993–0002. purity, or potency of the product as they Washington, DC. This meeting will Send one self-addressed adhesive label may relate to the safety or effectiveness include voting and deliberations on to assist that office in processing your of the product and, therefore, generally proposals for physician-focused requests. See the SUPPLEMENTARY should be documented in an annual payment models (PFPMs) submitted by INFORMATION section for electronic report. members of the public. All meetings are access to the draft guidance document. This draft guidance is being issued open to the public. FOR FURTHER INFORMATION CONTACT: consistent with FDA’s good guidance Michail Alterman, Center for Drug DATES: The PTAC meeting will occur on practices regulation (21 CFR 10.115). the following dates: Evaluation and Research, Food and The draft guidance, when finalized, will Drug Administration, 10903 New • Thursday—Friday, September 7–8, represent the current thinking of FDA 2017, from 9:00 a.m. to 5:00 p.m. ET. Hampshire Ave., Bldg. 51, Rm. 4245, on CMC postapproval manufacturing Silver Spring, MD 20993, 240–402– Please note that times are subject to changes for specified biological change. If the times change, registrants 9355; or Stephen Ripley, Center for products to be documented in annual Biologics Evaluation and Research, will be notified directly via email. reports. It does not establish any rights Food and Drug Administration, 10903 ADDRESSES: The September 7–8, 2017 for any person and is not binding on New Hampshire Ave., Bldg. 71, Rm. meeting will be held at the Hubert H. FDA or the public. You can use an 7301, Silver Spring, MD 20993–0002, Humphrey Building, 200 Independence alternative approach if it satisfies the 240–402–7911. Avenue SW., Washington, DC, 20201. requirements of the applicable statutes SUPPLEMENTARY INFORMATION: and regulations. FOR FURTHER INFORMATION CONTACT: Ann Page, Designated Federal Official, at the I. Background II. The Paperwork Reduction Act of Office of Health Policy, Assistant FDA is announcing the availability of 1995 Secretary for Planning and Evaluation, a draft guidance for industry entitled This draft guidance refers to U.S. Department of Health and Human ‘‘CMC Postapproval Manufacturing previously approved collections of Services, 200 Independence Ave. SW., sradovich on DSK3GMQ082PROD with NOTICES Changes for Specified Biological information found in FDA regulations. Washington, DC 20201, (202) 690–6870. Products To Be Documented in Annual These collections of information are SUPPLEMENTARY INFORMATION: Reports.’’ Applicants must notify the subject to review by the Office of Agency of a change to an approved BLA Management and Budget (OMB) under I. Purpose in accordance with all statutory and the Paperwork Reduction Act of 1995 The Physician-Focused Payment regulatory requirements—including (44 U.S.C. 3501–3520). The collections Model Technical Advisory Committee section 506A of the Federal Food, Drug, of information in § 601.12 have been (‘‘the Committee’’) is required by the VerDate Sep<11>2014 17:00 Aug 08, 2017 Jkt 241001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 E:\FR\FM\09AUN1.SGM 09AUN1

37234 Federal Register / Vol. 82, No. 152 / Wednesday, August 9, 2017 / Notices Medicare Access and CHIP registrants shortly after completing the National Institute on Drug Abuse, NIH, Reauthorization Act of 2015, 42 U.S.C registration process. DHHS, Room 4227, MSC 9550, 6001 1395ee. This Committee is also Executive Boulevard, Bethesda, MD 20892– IV. Special Accommodations 9550, (301) 827–5702, lf33c.nih.gov. governed by provisions of the Federal Advisory Committee Act, as amended (5 If sign language interpretation or other (Catalogue of Federal Domestic Assistance reasonable accommodation for a Program No.: 93.279, Drug Abuse and U.S.C App.), which sets forth standards Addiction Research Programs, National for the formation and use of federal disability is needed, please contact Institutes of Health, HHS) advisory committees. In accordance Angela Tejeda, no later than August 24, with its statutory mandate, the 2017. Please submit your requests by Dated: August 3, 2017. Committee is to review physician- email to Angela.Tejeda@hhs.gov or by Sylvia L. Neal, focused payment model proposals and calling 202–401–8297. Program Analyst, Office of Federal Advisory prepare recommendations regarding Committee Policy. V. Copies of the PTAC Charter and whether such models meet criteria that [FR Doc. 2017–16733 Filed 8–8–17; 8:45 am] Meeting Material were established through rulemaking by BILLING CODE 4140–01–P the Secretary of Health and Human The Secretary’s Charter for the Services (the Secretary). The Committee Physician-Focused Payment Model is composed of 11 members appointed Technical Advisory Committee is DEPARTMENT OF HEALTH AND by the Comptroller General. available on the ASPE Web site at HUMAN SERVICES https://aspe.hhs.gov/charter-physician- II. Agenda focused-payment-model-technical- National Institutes of Health At the September 7–8, 2017, the advisory-committee. Additional material for this meeting Center for Scientific Review; Notice of Committee will hear presentations on Closed Meetings PFPMs that are ready for Committee can be found on the PTAC Web site. For deliberation. The presentations will be updates and announcements, please use Pursuant to section 10(d) of the followed by public comment and the link to subscribe to the PTAC email Federal Advisory Committee Act, as Committee deliberation. If the listserv. amended, notice is hereby given of the Committee completes deliberations, Dated: August 3, 2017. following meetings. voting will occur on recommendations John R. Graham, The meetings will be closed to the to the Secretary of Health and Human Acting Assistant Secretary for Planning and public in accordance with the Services. There will be time allocated Evaluation. provisions set forth in sections for public comment on agenda items. [FR Doc. 2017–16784 Filed 8–8–17; 8:45 am] 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Documents will be posted on the BILLING CODE 4150–05–P as amended. The grant applications and Committee Web site and distributed on the discussions could disclose the Committee listserv prior to the confidential trade secrets or commercial public meeting. The agenda is subject to DEPARTMENT OF HEALTH AND property such as patentable material, change. If the agenda does change, we HUMAN SERVICES and personal information concerning will inform registrants and update our individuals associated with the grant Web site to reflect any changes. National Institutes of Health applications, the disclosure of which would constitute a clearly unwarranted III. Meeting Attendance National Institute on Drug Abuse; invasion of personal privacy. The meeting is open to the public. Notice of Closed Meeting Name of Committee: Center for Scientific The public may also attend via Pursuant to section 10(d) of the Review Special Emphasis Panel, RFA–MH– conference call or view the meeting via Federal Advisory Committee Act, as 17–650: Implementation Science for the livestream at www.hhs.gov/live. The amended, notice is hereby given of the Prevention and Treatment of Mental and/or conference call dial-in information will Substance Use Disorders in Low- and following meeting. be sent to registrants prior to the Middle-income Countries (U01). The meeting will be closed to the Date: September 4–5, 2017. meeting. public in accordance with the Time: 8:00 a.m. to 6:30 p.m. Meeting Registration provisions set forth in sections Agenda: To review and evaluate grant 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., applications. The public may attend the meetings as amended. The contract proposals and Place: President Hotel, 4 Alexander Road, in-person or participate by phone via the discussions could disclose Bantry Bay, Cape Town, 8001, South Africa. audio teleconference. Space is limited confidential trade secrets or commercial Contact Person: Seetha Bhagavan, Ph.D., and registration is preferred in order to property such as patentable material, Scientific Review Officer, Center for attend in-person or by phone. and personal information concerning Scientific Review, National Institutes of Registration may be completed online at Health, 6701 Rockledge Drive, Room 5194, individuals associated with the contract www.regonline.com/PTACMeetings MSC 7846, Bethesda, MD 20892, (301) 237– proposals, the disclosure of which 9838, bhagavas@csr.nih.gov. Registration. would constitute a clearly unwarranted The following information is Name of Committee: Center for Scientific invasion of personal privacy. Review Special Emphasis Panel, PAR–17– submitted when registering: Name of Committee: National Institute on 076: High-End Instrumentation (HEI) Grant Name: Drug Abuse Special Emphasis Panel; Program (S10). Company/organization name: Informatics Support for NIDA (8940). Date: September 12, 2017. sradovich on DSK3GMQ082PROD with NOTICES Postal address: Date: August 31, 2017. Time: 8:00 a.m. to 6:00 p.m. Email address: Time: 9:00 a.m. to 4:00 p.m. Agenda: To review and evaluate grant Agenda: To review and evaluate contract applications. Persons wishing to attend this proposals. Place: Ritz-Carlton Hotel at Pentagon City, meeting must register by following the Place: Hilton Garden Inn Bethesda, 7301 1250 South Hayes Street, Arlington, VA instructions in the ‘‘Meeting Waverly Street, Bethesda, MD 20814. 22202. Registration’’ section of this notice. A Contact Person: Lyle Furr, Scientific Contact Person: Songtao Liu, MD, confirmation email will be sent to Review Officer, Office of Extramural Affairs, Scientific Review Officer, Center for VerDate Sep<11>2014 17:00 Aug 08, 2017 Jkt 241001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 E:\FR\FM\09AUN1.SGM 09AUN1


Document Created: 2017-08-09 02:18:31
Document Modified: 2017-08-09 02:18:31
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
ActionNotice of public meetings.
DatesThe PTAC meeting will occur on the following dates:
ContactAnn Page, Designated Federal Official, at the Office of Health Policy, Assistant Secretary for Planning and Evaluation, U.S. Department of Health and Human Services, 200 Independence Ave. SW., Washington, DC 20201, (202) 690-6870.
FR Citation82 FR 37233 
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