Solicitation of Nominations for Membership To Serve on the National Advisory Council on Migrant Health, 68506-68507 [2021-26199]
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Federal Register / Vol. 86, No. 229 / Thursday, December 2, 2021 / Notices
labeling a statement provided for in
section 403(r)(6) of the FD&C Act. In
accordance with these requirements,
submissions must include: (1) The name
and address of the manufacturer,
packer, or distributor of the dietary
supplement product; (2) the text of the
statement that is being made; (3) the
name of the dietary ingredient or
supplement that is the subject of the
statement; (4) the name of the dietary
supplement (including the brand name);
and (5) the signature of a responsible
individual or the person who can certify
the accuracy of the information
presented, and who must certify that the
information contained in the notice is
complete and accurate, and that the
notifying firm has substantiation that
the statement is truthful and not
misleading.
Our electronic form (Form FDA 3955)
allows respondents to the information
collection to electronically submit
notifications to FDA via the Food
Applications Regulatory Management
(FARM) system. Firms that prefer to
submit a paper notification in a format
of their own choosing will still have the
option to do so; however, Form FDA
3955 prompts respondents to include
certain elements in their structure/
function claim notification (SFCN)
described in § 101.93 in a standard
electronic format and helps respondents
organize their SFCN to include only the
information needed for our review of
the claim. Note that the SFCN, whether
electronic or paper, is used for all
claims made pursuant to section
403(r)(6) of the FD&C Act, including
nutrient deficiency claims and general
well-being claims in addition to
structure/function claims. The
electronic form, and any optional
elements prepared as attachments to the
form (e.g., label), can be submitted in
electronic format via FARM.
Submissions of SFCNs will continue to
be allowed in paper format. We use this
information to evaluate whether
statements made for dietary ingredients
or dietary supplements are permissible
under section 403(r)(6) of the FD&C Act.
Description of Respondents:
Respondents to this collection of
information include manufacturers,
packers, or distributors of dietary
supplements that bear section 403(r)(6)
of the FD&C Act statements on their
labels or labeling.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
101.93 ..................................................................
1 There
3,690
1
Total annual
responses
3,690
Average burden per
response
0.75 (45 minutes) ...........
Total hours
2,768
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate.
This estimate is based on our experience
with this information collection and the
number of notifications received in the
past 3 years, which has remained
constant.
Dated: November 26, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–26172 Filed 12–1–21; 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 the National
Advisory Council on Migrant Health
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Request for nominations.
AGENCY:
lotter on DSK11XQN23PROD with NOTICES1
Number of
responses per
respondent
Number of
respondents
21 CFR section
HRSA is seeking nominations
of qualified candidates to be considered
for appointment as members of the
National Advisory Council on Migrant
Health (NACMH or advisory
committee). The NACMH advises,
SUMMARY:
VerDate Sep<11>2014
16:49 Dec 01, 2021
Jkt 256001
consults with, and makes
recommendations to the HHS Secretary
concerning the organization, operation,
selection, and funding of Migrant Health
Centers (MHCs) and other entities under
grants and contracts under the Public
Health Service (PHS) Act. HRSA is
seeking nominations to fill seven
positions on the NACMH.
DATES: HRSA will receive written
nominations for NACMH membership
on a continuous basis.
ADDRESSES: Nomination packages must
be submitted in hard copy to the
Designated Federal Official (DFO),
NACMH, Strategic Initiatives Division,
Office of Policy and Program
Development, Bureau of Primary Health
Care, HRSA, 16N38B, 5600 Fishers
Lane, Rockville, Maryland 20857.
FOR FURTHER INFORMATION CONTACT: All
requests for information regarding
NACMH nominations should be sent via
email to Esther Paul, DFO, NACMH,
HRSA at hrsabphcoppdnacmh@hrsa.gov
or 301–594–4300. The NACMH charter
and list of current membership are
available on the NACMH website at
https://bphc.hrsa.gov/quality
improvement/strategicpartnerships/
nacmh/.
SUPPLEMENTARY INFORMATION: NACMH
was established and authorized under
section 217 of the PHS Act (42 U.S.C.
218) to advise, consult with, and make
recommendations to the HHS Secretary
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
concerning the organization, operation,
selection, and funding of MHCs and
other entities under grants and contracts
under section 330(g) of the PHS Act (42
U.S.C. 254b(g)). The NACMH meets
twice each calendar year, or at the
discretion of the DFO in consultation
with the Chair.
Nominations: HRSA is requesting
nominations for voting members to
serve as Special Government Employees
(SGEs) on the NACMH to fill seven open
positions. Specifically, HRSA is
requesting nominations for the
following positions: Board Member
(three nominees), Board Member/Patient
(three nominees), and Administrator
Provider (one nominee). The Board
Member nominees must be members or
members-elect of a governing board of
an organization receiving funding under
section 330(g) of the PHS Act. The
Board Member/Patient nominees must
also be patients of the health centers
that they represent. Additionally, Board
Member nominees must be familiar with
the delivery of primary health care to
migratory and seasonal agricultural
workers (MSAWs) and their families.
The Administrator/Provider nominee
must be qualified by training and
experience in the medical sciences or in
the administration of health programs
for MSAWs and their families. Another
individual or organization may
nominate an interested applicant.
E:\FR\FM\02DEN1.SGM
02DEN1
lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 86, No. 229 / Thursday, December 2, 2021 / Notices
The HHS Secretary appoints NACMH
members with the expertise needed to
fulfill the duties of the advisory
committee. The membership
requirements set-forth under section 217
of the PHS Act (42 U.S.C. 218) require
that the NACMH consist of 15 members,
at least 12 of whom shall be members
of the governing boards of MHCs or
other entities assisted under section
330(g) of the PHS Act (42 U.S.C.
254b(g)). Of these 12 board members, at
least nine shall be individuals who are
MHC patients and familiar with the
delivery of health care to MSAWs. The
remaining three NACMH members shall
be individuals qualified by training and
experience in the medical sciences or in
the administration of health programs.
New members filling a vacancy
occurring prior to term expiration may
serve only for the remainder of such
term. Members may serve after term
expiration until their successors take
office, but no longer than 120 days.
Nominees must reside in the United
States, and international travel cannot
be funded.
Individuals selected for appointment
to the NACMH will be invited to serve
for up to 4 years. Members appointed as
SGEs receive a stipend and
reimbursement for per diem and travel
expenses incurred for attending
NACMH meetings and/or conducting
other business on behalf of the NACMH,
as authorized by 5 U.S.C. 5703 for
persons employed intermittently in
government service.
The following information must be
included in the package of materials
submitted for each individual
nominated for consideration: (1)
NACMH nomination form, which can be
requested by contacting the DFO at the
email provided above; (2) three letters of
reference; (3) a statement of prior
service on the NACMH; 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
NACMH membership 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.
Individuals under consideration for
appointment will be required to provide
VerDate Sep<11>2014
16:49 Dec 01, 2021
Jkt 256001
detailed information regarding their
financial holdings, consultancies, and
research grants or contracts. Disclosure
of this information is required in order
for HRSA ethics officials to determine
whether there is a potential conflict of
interest between the SGE’s public duties
as a member of the NACMH and their
private interests, including an
appearance of a loss of impartiality as
defined by federal laws and regulations,
and to identify any required remedial
action needed to address the potential
conflict.
Authority: NACMH is authorized by
section 217 of the PHS Act, Title 42
U.S.C. 218, and established by the HHS
Secretary. It is governed by the Federal
Advisory Committee Act (5 U.S.C.
Appendix 2), which sets forth standards
for the formation and use of advisory
committees.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2021–26199 Filed 12–1–21; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Current List of HHS-Certified
Laboratories and Instrumented Initial
Testing Facilities Which Meet Minimum
Standards To Engage in Urine and Oral
Fluid Drug Testing for Federal
Agencies
Substance Abuse and Mental
Health Services Administration, HHS.
ACTION: Notice.
AGENCY:
The Department of Health and
Human Services (HHS) notifies federal
agencies of the laboratories and
Instrumented Initial Testing Facilities
(IITFs) currently certified to meet the
standards of the Mandatory Guidelines
for Federal Workplace Drug Testing
Programs using Urine or Oral Fluid
(Mandatory Guidelines).
FOR FURTHER INFORMATION CONTACT:
Anastasia Donovan, Division of
Workplace Programs, SAMHSA/CSAP,
5600 Fishers Lane, Room 16N06B,
Rockville, Maryland 20857; 240–276–
2600 (voice); Anastasia.Donovan@
samhsa.hhs.gov (email).
SUPPLEMENTARY INFORMATION: In
accordance with Section 9.19 of the
Mandatory Guidelines, a notice listing
all currently HHS-certified laboratories
and IITFs is published in the Federal
Register during the first week of each
month. If any laboratory or IITF
certification is suspended or revoked,
SUMMARY:
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
68507
the laboratory or IITF will be omitted
from subsequent lists until such time as
it is restored to full certification under
the Mandatory Guidelines.
If any laboratory or IITF has
withdrawn from the HHS National
Laboratory Certification Program (NLCP)
during the past month, it will be listed
at the end and will be omitted from the
monthly listing thereafter.
This notice is also available on the
internet at https://www.samhsa.gov/
workplace/resources/drug-testing/
certified-lab-list.
The Department of Health and Human
Services (HHS) notifies federal agencies
of the laboratories and Instrumented
Initial Testing Facilities (IITFs)
currently certified to meet the standards
of the Mandatory Guidelines for Federal
Workplace Drug Testing Programs
(Mandatory Guidelines) using Urine and
of the laboratories currently certified to
meet the standards of the Mandatory
Guidelines using Oral Fluid.
The Mandatory Guidelines using
Urine were first published in the
Federal Register on April 11, 1988 (53
FR 11970), and subsequently revised in
the Federal Register on June 9, 1994 (59
FR 29908); September 30, 1997 (62 FR
51118); April 13, 2004 (69 FR 19644);
November 25, 2008 (73 FR 71858);
December 10, 2008 (73 FR 75122); April
30, 2010 (75 FR 22809); and on January
23, 2017 (82 FR 7920).
The Mandatory Guidelines using Oral
Fluid were first published in the
Federal Register on October 25, 2019
(84 FR 57554) with an effective date of
January 1, 2020.
The Mandatory Guidelines were
initially developed in accordance with
Executive Order 12564 and section 503
of Public Law 100–71 and allowed urine
drug testing only. The Mandatory
Guidelines using Urine have since been
revised, and new Mandatory Guidelines
allowing for oral fluid drug testing have
been published. The Mandatory
Guidelines require strict standards that
laboratories and IITFs must meet in
order to conduct drug and specimen
validity tests on specimens for federal
agencies. HHS does not allow IITFs to
conduct oral fluid testing.
To become certified, an applicant
laboratory or IITF must undergo three
rounds of performance testing plus an
on-site inspection. To maintain that
certification, a laboratory or IITF must
participate in a quarterly performance
testing program plus undergo periodic,
on-site inspections.
Laboratories and IITFs in the
applicant stage of certification are not to
be considered as meeting the minimum
requirements described in the HHS
Mandatory Guidelines using Urine and/
E:\FR\FM\02DEN1.SGM
02DEN1
]]>Agencies
[Federal Register Volume 86, Number 229 (Thursday, December 2, 2021)]
[Notices]
[Pages 68506-68507]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-26199]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Solicitation of Nominations for Membership To Serve on the
National Advisory Council on Migrant Health
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Request for nominations.
-----------------------------------------------------------------------
SUMMARY: HRSA is seeking nominations of qualified candidates to be
considered for appointment as members of the National Advisory Council
on Migrant Health (NACMH or advisory committee). The NACMH advises,
consults with, and makes recommendations to the HHS Secretary
concerning the organization, operation, selection, and funding of
Migrant Health Centers (MHCs) and other entities under grants and
contracts under the Public Health Service (PHS) Act. HRSA is seeking
nominations to fill seven positions on the NACMH.
DATES: HRSA will receive written nominations for NACMH membership on a
continuous basis.
ADDRESSES: Nomination packages must be submitted in hard copy to the
Designated Federal Official (DFO), NACMH, Strategic Initiatives
Division, Office of Policy and Program Development, Bureau of Primary
Health Care, HRSA, 16N38B, 5600 Fishers Lane, Rockville, Maryland
20857.
FOR FURTHER INFORMATION CONTACT: All requests for information regarding
NACMH nominations should be sent via email to Esther Paul, DFO, NACMH,
HRSA at [email protected] or 301-594-4300. The NACMH charter
and list of current membership are available on the NACMH website at
https://bphc.hrsa.gov/qualityimprovement/strategicpartnerships/nacmh/.
SUPPLEMENTARY INFORMATION: NACMH was established and authorized under
section 217 of the PHS Act (42 U.S.C. 218) to advise, consult with, and
make recommendations to the HHS Secretary concerning the organization,
operation, selection, and funding of MHCs and other entities under
grants and contracts under section 330(g) of the PHS Act (42 U.S.C.
254b(g)). The NACMH meets twice each calendar year, or at the
discretion of the DFO in consultation with the Chair.
Nominations: HRSA is requesting nominations for voting members to
serve as Special Government Employees (SGEs) on the NACMH to fill seven
open positions. Specifically, HRSA is requesting nominations for the
following positions: Board Member (three nominees), Board Member/
Patient (three nominees), and Administrator Provider (one nominee). The
Board Member nominees must be members or members-elect of a governing
board of an organization receiving funding under section 330(g) of the
PHS Act. The Board Member/Patient nominees must also be patients of the
health centers that they represent. Additionally, Board Member nominees
must be familiar with the delivery of primary health care to migratory
and seasonal agricultural workers (MSAWs) and their families. The
Administrator/Provider nominee must be qualified by training and
experience in the medical sciences or in the administration of health
programs for MSAWs and their families. Another individual or
organization may nominate an interested applicant.
[[Page 68507]]
The HHS Secretary appoints NACMH members with the expertise needed
to fulfill the duties of the advisory committee. The membership
requirements set-forth under section 217 of the PHS Act (42 U.S.C. 218)
require that the NACMH consist of 15 members, at least 12 of whom shall
be members of the governing boards of MHCs or other entities assisted
under section 330(g) of the PHS Act (42 U.S.C. 254b(g)). Of these 12
board members, at least nine shall be individuals who are MHC patients
and familiar with the delivery of health care to MSAWs. The remaining
three NACMH members shall be individuals qualified by training and
experience in the medical sciences or in the administration of health
programs. New members filling a vacancy occurring prior to term
expiration may serve only for the remainder of such term. Members may
serve after term expiration until their successors take office, but no
longer than 120 days. Nominees must reside in the United States, and
international travel cannot be funded.
Individuals selected for appointment to the NACMH will be invited
to serve for up to 4 years. Members appointed as SGEs receive a stipend
and reimbursement for per diem and travel expenses incurred for
attending NACMH meetings and/or conducting other business on behalf of
the NACMH, as authorized by 5 U.S.C. 5703 for persons employed
intermittently in government service.
The following information must be included in the package of
materials submitted for each individual nominated for consideration:
(1) NACMH nomination form, which can be requested by contacting the DFO
at the email provided above; (2) three letters of reference; (3) a
statement of prior service on the NACMH; 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 NACMH membership 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.
Individuals under consideration for appointment will be required to
provide detailed information regarding their financial holdings,
consultancies, and research grants or contracts. Disclosure of this
information is required in order for HRSA ethics officials to determine
whether there is a potential conflict of interest between the SGE's
public duties as a member of the NACMH and their private interests,
including an appearance of a loss of impartiality as defined by federal
laws and regulations, and to identify any required remedial action
needed to address the potential conflict.
Authority: NACMH is authorized by section 217 of the PHS Act, Title
42 U.S.C. 218, and established by the HHS Secretary. It is governed by
the Federal Advisory Committee Act (5 U.S.C. Appendix 2), which sets
forth standards for the formation and use of advisory committees.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2021-26199 Filed 12-1-21; 8:45 am]
BILLING CODE 4165-15-P
