Meetings Announcement for the Physician-Focused Payment Model Technical Advisory Committee Required by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), 37233-37234 [2017-16784]
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Federal Register / Vol. 82, No. 152 / Wednesday, August 9, 2017 / Notices
and Cosmetic Act (the FD&C Act) (21
U.S.C. 356a) and 21 CFR 601.12. Section
506A of the FD&C Act provides
requirements for making and reporting
manufacturing changes to an approved
application or license and for
distributing a drug product made with
such changes. Under § 601.12, each
post-approval change in the product,
production process, quality controls,
equipment, facilities, or responsible
personnel established in an approved
BLA is categorized into one of three
reporting categories:
• Major change: Applicants must
submit and receive FDA’s approval of a
supplement to the BLA before the
product produced with the
manufacturing change is distributed.
• Moderate change: Applicants must
submit a supplement at least 30 days
before the product is distributed or, in
some cases, the product may be
distributed immediately upon FDA’s
receipt of the supplement.
• Minor change: Applicants may
proceed with the change but must notify
FDA of the change in an annual report.
This draft guidance provides
recommendations for changes that
generally should be documented in an
annual report. It discusses the contents
of an annual report notification and lists
examples of postapproval
manufacturing changes for BLAs that
FDA generally considers to have a
minimal potential to have an adverse
effect on the identity, strength, quality,
purity, or potency of the product as they
may relate to the safety or effectiveness
of the product and, therefore, generally
should be documented in an annual
report.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on CMC postapproval manufacturing
changes for specified biological
products to be documented in annual
reports. It does not establish any rights
for any person and is not binding on
FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations.
I. Background
sradovich on DSK3GMQ082PROD with NOTICES
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://www.regulations
.gov and insert the docket number,
found in brackets in the heading of this
document, into the ‘‘Search’’ box and
follow the prompts and/or go to the
Dockets Management Staff, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
Submit written requests for single
copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002 or to the Office of Communication,
Outreach and Development, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
3128, Silver Spring, MD 20993–0002.
Send one self-addressed adhesive label
to assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Michail Alterman, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 4245,
Silver Spring, MD 20993, 240–402–
9355; or Stephen Ripley, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993–0002,
240–402–7911.
SUPPLEMENTARY INFORMATION:
II. The Paperwork Reduction Act of
1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in § 601.12 have been
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘CMC Postapproval Manufacturing
Changes for Specified Biological
Products To Be Documented in Annual
Reports.’’ Applicants must notify the
Agency of a change to an approved BLA
in accordance with all statutory and
regulatory requirements—including
section 506A of the Federal Food, Drug,
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approved under OMB control number
0910–0338.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/default.htm, or https://
www.regulations.gov.
Dated: August 3, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–16718 Filed 8–8–17; 8:45 am]
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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.
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:
SUMMARY:
I. Purpose
The Physician-Focused Payment
Model Technical Advisory Committee
(‘‘the Committee’’) is required by the
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37234
Federal Register / Vol. 82, No. 152 / Wednesday, August 9, 2017 / Notices
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 physicianfocused 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.
sradovich on DSK3GMQ082PROD with NOTICES
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/PTACMeetings
Registration.
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
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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 Angela.Tejeda@hhs.gov 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-physicianfocused-payment-model-technicaladvisory-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]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Drug Abuse;
Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel;
Informatics Support for NIDA (8940).
Date: August 31, 2017.
Time: 9:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: Hilton Garden Inn Bethesda, 7301
Waverly Street, Bethesda, MD 20814.
Contact Person: Lyle Furr, Scientific
Review Officer, Office of Extramural Affairs,
PO 00000
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National Institute on Drug Abuse, NIH,
DHHS, Room 4227, MSC 9550, 6001
Executive Boulevard, Bethesda, MD 20892–
9550, (301) 827–5702, lf33c.nih.gov.
(Catalogue of Federal Domestic Assistance
Program No.: 93.279, Drug Abuse and
Addiction Research Programs, National
Institutes of Health, HHS)
Dated: August 3, 2017.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2017–16733 Filed 8–8–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, RFA–MH–
17–650: Implementation Science for the
Prevention and Treatment of Mental and/or
Substance Use Disorders in Low- and
Middle-income Countries (U01).
Date: September 4–5, 2017.
Time: 8:00 a.m. to 6:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: President Hotel, 4 Alexander Road,
Bantry Bay, Cape Town, 8001, South Africa.
Contact Person: Seetha Bhagavan, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5194,
MSC 7846, Bethesda, MD 20892, (301) 237–
9838, bhagavas@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, PAR–17–
076: High-End Instrumentation (HEI) Grant
Program (S10).
Date: September 12, 2017.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Ritz-Carlton Hotel at Pentagon City,
1250 South Hayes Street, Arlington, VA
22202.
Contact Person: Songtao Liu, MD,
Scientific Review Officer, Center for
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]]>Agencies
[Federal Register Volume 82, Number 152 (Wednesday, August 9, 2017)]
[Notices]
[Pages 37233-37234]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-16784]
-----------------------------------------------------------------------
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
Angela.Tejeda@hhs.gov 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
