Solicitation of Nominations for Membership To Serve on Tribal Advisory Council, 53008-53009 [2020-18865]
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Federal Register / Vol. 85, No. 167 / Thursday, August 27, 2020 / Notices
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
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Submit written requests for single
copies of the draft guidance to Division
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Evaluation and Research, Food and
Drug Administration, 10001 New
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4th Floor, Silver Spring, MD 20993–
0002 or the Office of Communication,
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the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
FOR FURTHER INFORMATION CONTACT:
Shanthi Marur, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 2369,
Silver Spring, MD 20993–0002, 240–
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Biologics Evaluation and Research,
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7301, Silver Spring, MD 20993–0002,
240–402–7911.
SUPPLEMENTARY INFORMATION:
khammond on DSKJM1Z7X2PROD with NOTICES
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Evaluating Cancer Drugs in Patients
with Central Nervous System
Metastases.’’ This draft guidance
provides recommendations for sponsors
designing clinical trials of drugs and
biological products regulated by CDER
and CBER that are intended to support
product labeling describing the
antitumor activity in patients with
central nervous system (CNS)
metastases from solid tumors originating
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outside the CNS. Specifically, the draft
guidance includes recommendations
regarding the patient population,
available therapy, prior therapies,
assessment of CNS disease, study
endpoints, and leptomeningeal disease.
The draft guidance describes that CNS
metastases should be evaluated in the
context of the entire disease burden and
discusses how treatment effects may be
described in drug labeling. The
recommendations pertain to clinical
trials for systemic anticancer drugs
where patients with CNS metastases are
included in the study population. These
recommendations are also applicable to
trials conducted exclusively in patients
with CNS metastases.
CNS metastases are associated with
significant morbidity and mortality and
development of therapeutic products for
patients with CNS metastases is needed.
FDA has participated in efforts to
facilitate drug development for patients
with CNS metastases including a March
2019 ‘‘Workshop on Product
Development for CNS Metastases’’.
Stakeholders at this meeting stated there
is a need for further FDA guidance on
specific topics including identifying
optimal study endpoints. Study design
challenges for CNS metastases include
uncertainty regarding optimal
endpoints, lack of standardized
response assessments, understanding
how CNS metastases are evaluated in
the context of the entire burden of
metastatic disease to characterize a
drug’s potential benefit (e.g., timing of
CNS radiographic assessments relative
to other sites of metastases), and
interpreting radiographic response in
the setting of recent radiation therapy or
surgery. This draft guidance is intended
to provide recommendations on these
study design challenges.
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 ‘‘Evaluating Cancer Drugs in Patients
with Central Nervous System
Metastases.’’ 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.
II. 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
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of information in 21 CFR part 312 have
been approved under OMB control
number 0910–0014; the collections of
information in 21 CFR part 314 have
been approved under OMB control
number 0910–0001; the collections of
information in 21 CFR part 601 have
been approved under 0910–0338; and
the collections of information in 21 CFR
201.56 and 201.57 have been approved
under OMB control number 0910–0572.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, or https://
www.regulations.gov.
Dated: August 24, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–18894 Filed 8–26–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Solicitation of Nominations for
Membership To Serve on Tribal
Advisory Council
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
HRSA is seeking additional
nominations of qualified tribal officials
as candidates for consideration for
appointment as voluntary delegate
members of the HRSA Tribal Advisory
Council (TAC), which is being
established. Specifically, HRSA requests
submissions of nominations of qualified
tribal officials from the Indian Health
Service (IHS) geographic areas of:
Alaska; Albuquerque; Billings; Navajo;
Phoenix; and Tucson. Nominations for
membership must be received on or
before September 30, 2020. This will
allow tribes and tribal serving
organizations from the IHS geographic
areas noted above, the additional time
needed to identify qualified tribal
officials as candidates and submit
comprehensive nomination packages.
FOR FURTHER INFORMATION CONTACT:
CAPT Elijah K. Martin, Jr. EdD, MPH,
Manager, Tribal Health Affairs, Office of
Health Equity, HRSA, 5600 Fishers
Lane, Room 13N44, Rockville, Maryland
SUMMARY:
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khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 85, No. 167 / Thursday, August 27, 2020 / Notices
20857, 301–443–7526, aianhealth@
hrsa.gov.
SUPPLEMENTARY INFORMATION: The HRSA
TAC will be established to engage in
regular and meaningful collaboration
and consultation with tribal officials on
policies that have tribal implications
and substantial direct effect on Indian
tribes. HRSA, an agency of the U.S.
Department of Health and Human
Services (HHS), is the primary federal
agency for improving health care to
people who are geographically isolated,
and/or economically or medically
vulnerable. This includes people living
with HIV/AIDS; pregnant women,
mothers, and their families; and those
otherwise unable to access high-quality
health care. HRSA supports the training
of health professionals, the distribution
of providers to areas where they are
needed most, and improvements in
health care delivery. HRSA also
oversees organ, bone marrow, and cord
blood donation. It also oversees the
National Vaccine Injury Compensation
Program which can provide
compensation to individuals in the rare
cases that they are harmed by certain
covered vaccinations and maintains
databases that flag providers with a
record of health care malpractice, waste,
fraud, and abuse for federal, state, and
local use.
The HRSA TAC will be the vehicle for
acquiring a broad range of tribal views,
determining the impact of HRSA
programs on the American Indian and
Alaska Natives health systems and
population, developing innovative
approaches to deliver health care, and
assisting with effective tribal
consultation. The HRSA TAC will hold
one meeting each calendar year, or at
the discretion of HRSA in consultation
with the Chair. These meetings may be
held in-person or virtually. The HRSA
TAC will support, not supplant, any
other government-to-government
consultation activities that HRSA
undertakes. In addition to assisting
HRSA in the planning and coordination
of tribal consultation sessions, the
HRSA TAC will advise HRSA regarding
the government-togovernment
consultation process and will help
ensure that HRSA activities and policies
that impact Indian country are brought
to the attention of all tribal leaders.
Nominations: A previous notice
regarding the HRSA TAC was published
in the Federal Register on February 6,
2020. The deadline for submissions was
extended to July 6, 2020, and while
HRSA received additional nomination
packets, it did not receive a sufficient
number of nomination packets to
consider for each of the 12 vacant
VerDate Sep<11>2014
17:09 Aug 26, 2020
Jkt 250001
positions. HRSA is requesting
nominations of tribal officials to serve as
HRSA TAC delegate members to fill up
to 12 voluntary positions on the HRSA
TAC; one authorized tribal
representative (and one designated
alternate) from each of the Indian Health
Service geographic areas. HRSA
continues to seek additional qualified
nominees, specifically from eligible
tribal officials from the IHS geographic
areas of: Alaska; Albuquerque; Billings;
Navajo; Phoenix; and Tucson. The
HRSA Administrator will appoint HRSA
TAC delegate members with the
expertise needed to fulfill the duties of
the Advisory Council. Nominees will be
considered in the following priority
order:
1. Tribal president, chairperson, or
governor;
2. Tribal vice president, vicechairperson, or lieutenant governor;
3. Elected or appointed tribal official;
and
4. Designated tribal official.
Interested applicants may selfnominate or be nominated by another
individual or organization.
Individuals selected for appointment
to the HRSA TAC will be invited to
serve terms of up to 2 years. Appointed
delegate members will receive per diem
and travel expenses incurred for
attending HRSA TAC meetings and/or
conducting other authorized and
approved business on behalf of the
HRSA TAC.
The following information must be
included in the package of materials
submitted for each individual
nominated for consideration: (1) Name
of the nominee, a description of the
interests the nominee would represent,
and a description of the nominee’s
experience and interest in American
Indian and Alaska Native access to
health care; (2) evidence that the
nominee is a duly elected or appointed
tribal leader or tribal officer, or has been
designated with authority to act on
behalf of the duly elected or appointed
tribal leader or officer, and is authorized
to represent a tribal government; (3) a
written commitment from the nominee
that they will actively participate in
good faith in HRSA TAC meetings; and
(4) a current copy of the nominee’s
curriculum vitae. Nomination packages
may be submitted directly by the
individual being nominated or by the
person/organization recommending the
candidate.
HHS endeavors to ensure that the
membership of the HRSA TAC is fairly
balanced in terms of points of view
represented and that individuals from a
broad representation of geographic
areas, gender, and ethnic and minority
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53009
groups, as well as individuals with
disabilities, are considered for
membership. Appointments shall be
made without discrimination on the
basis of age, ethnicity, gender, sexual
orientation, or cultural, religious, or
socioeconomic status.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2020–18865 Filed 8–26–20; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request; Information
Collection Request Title: Be the
Match® Patient Support Center Survey;
OMB No. 0906–0004—Revision
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
AGENCY:
ACTION:
Notice.
In compliance with the
Paperwork Reduction Act of 1995,
HRSA 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. OMB may act on
HRSA’s ICR only after the 30 day
comment period for this notice has
closed.
SUMMARY:
Comments on this ICR should be
received no later than September 28,
2020.
DATES:
Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under Review—Open for
Public Comments’’ or by using the
search function.
ADDRESSES:
To
request a copy of the clearance requests
submitted to OMB for review, email Lisa
Wright-Solomon, the HRSA Information
Collection Clearance Officer at
paperwork@hrsa.gov or call (301) 443–
1984.
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
E:\FR\FM\27AUN1.SGM
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]]>Agencies
[Federal Register Volume 85, Number 167 (Thursday, August 27, 2020)]
[Notices]
[Pages 53008-53009]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-18865]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Solicitation of Nominations for Membership To Serve on Tribal
Advisory Council
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: HRSA is seeking additional nominations of qualified tribal
officials as candidates for consideration for appointment as voluntary
delegate members of the HRSA Tribal Advisory Council (TAC), which is
being established. Specifically, HRSA requests submissions of
nominations of qualified tribal officials from the Indian Health
Service (IHS) geographic areas of: Alaska; Albuquerque; Billings;
Navajo; Phoenix; and Tucson. Nominations for membership must be
received on or before September 30, 2020. This will allow tribes and
tribal serving organizations from the IHS geographic areas noted above,
the additional time needed to identify qualified tribal officials as
candidates and submit comprehensive nomination packages.
FOR FURTHER INFORMATION CONTACT: CAPT Elijah K. Martin, Jr. EdD, MPH,
Manager, Tribal Health Affairs, Office of Health Equity, HRSA, 5600
Fishers Lane, Room 13N44, Rockville, Maryland
[[Page 53009]]
20857, 301-443-7526, [email protected].
SUPPLEMENTARY INFORMATION: The HRSA TAC will be established to engage
in regular and meaningful collaboration and consultation with tribal
officials on policies that have tribal implications and substantial
direct effect on Indian tribes. HRSA, an agency of the U.S. Department
of Health and Human Services (HHS), is the primary federal agency for
improving health care to people who are geographically isolated, and/or
economically or medically vulnerable. This includes people living with
HIV/AIDS; pregnant women, mothers, and their families; and those
otherwise unable to access high-quality health care. HRSA supports the
training of health professionals, the distribution of providers to
areas where they are needed most, and improvements in health care
delivery. HRSA also oversees organ, bone marrow, and cord blood
donation. It also oversees the National Vaccine Injury Compensation
Program which can provide compensation to individuals in the rare cases
that they are harmed by certain covered vaccinations and maintains
databases that flag providers with a record of health care malpractice,
waste, fraud, and abuse for federal, state, and local use.
The HRSA TAC will be the vehicle for acquiring a broad range of
tribal views, determining the impact of HRSA programs on the American
Indian and Alaska Natives health systems and population, developing
innovative approaches to deliver health care, and assisting with
effective tribal consultation. The HRSA TAC will hold one meeting each
calendar year, or at the discretion of HRSA in consultation with the
Chair. These meetings may be held in-person or virtually. The HRSA TAC
will support, not supplant, any other government-to-government
consultation activities that HRSA undertakes. In addition to assisting
HRSA in the planning and coordination of tribal consultation sessions,
the HRSA TAC will advise HRSA regarding the government-togovernment
consultation process and will help ensure that HRSA activities and
policies that impact Indian country are brought to the attention of all
tribal leaders.
Nominations: A previous notice regarding the HRSA TAC was published
in the Federal Register on February 6, 2020. The deadline for
submissions was extended to July 6, 2020, and while HRSA received
additional nomination packets, it did not receive a sufficient number
of nomination packets to consider for each of the 12 vacant positions.
HRSA is requesting nominations of tribal officials to serve as HRSA TAC
delegate members to fill up to 12 voluntary positions on the HRSA TAC;
one authorized tribal representative (and one designated alternate)
from each of the Indian Health Service geographic areas. HRSA continues
to seek additional qualified nominees, specifically from eligible
tribal officials from the IHS geographic areas of: Alaska; Albuquerque;
Billings; Navajo; Phoenix; and Tucson. The HRSA Administrator will
appoint HRSA TAC delegate members with the expertise needed to fulfill
the duties of the Advisory Council. Nominees will be considered in the
following priority order:
1. Tribal president, chairperson, or governor;
2. Tribal vice president, vice-chairperson, or lieutenant governor;
3. Elected or appointed tribal official; and
4. Designated tribal official.
Interested applicants may self-nominate or be nominated by another
individual or organization.
Individuals selected for appointment to the HRSA TAC will be
invited to serve terms of up to 2 years. Appointed delegate members
will receive per diem and travel expenses incurred for attending HRSA
TAC meetings and/or conducting other authorized and approved business
on behalf of the HRSA TAC.
The following information must be included in the package of
materials submitted for each individual nominated for consideration:
(1) Name of the nominee, a description of the interests the nominee
would represent, and a description of the nominee's experience and
interest in American Indian and Alaska Native access to health care;
(2) evidence that the nominee is a duly elected or appointed tribal
leader or tribal officer, or has been designated with authority to act
on behalf of the duly elected or appointed tribal leader or officer,
and is authorized to represent a tribal government; (3) a written
commitment from the nominee that they will actively participate in good
faith in HRSA TAC meetings; and (4) a current copy of the nominee's
curriculum vitae. Nomination packages may be submitted directly by the
individual being nominated or by the person/organization recommending
the candidate.
HHS endeavors to ensure that the membership of the HRSA TAC is
fairly balanced in terms of points of view represented and that
individuals from a broad representation of geographic areas, gender,
and ethnic and minority groups, as well as individuals with
disabilities, are considered for membership. Appointments shall be made
without discrimination on the basis of age, ethnicity, gender, sexual
orientation, or cultural, religious, or socioeconomic status.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2020-18865 Filed 8-26-20; 8:45 am]
BILLING CODE 4165-15-P
