National Biodefense Science Board, 60842-60843 [2021-23971]
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60842
Federal Register / Vol. 86, No. 211 / Thursday, November 4, 2021 / Notices
the distribution of uncertified and
possibly unsafe shellfish in interstate
commerce. Without the ICSSL, the
effectiveness of the NSSP would be
nullified. The ICSSL is also used to
identify U.S. shellfish dealers eligible to
obtain health certificates and export to
certain countries or regions.
FDA has been collecting information
to construct the ICSSL since 2001. FDA
is seeking to add one new data field to
the Form FDA 3038, the ‘‘FDA
Establishment Identifier’’ (FEI number).
The FEI number is a unique number
assigned by FDA to identify FDAregulated facilities. FDA will explore
whether the FEI can be used to retrieve
data on shellfish dealers from existing
FDA systems, which could reduce the
number of required data elements that
firms have to submit on Form FDA
3038.
The information collection also
includes providing certain documents
demonstrating compliance with the
NSSP. When a competent authority in
another country conducts an evaluation
to determine whether the U.S. food
safety control measures for molluscan
shellfish are equivalent to their system
of controls, the competent authority
may require FDA to provide information
and records demonstrating compliance
with the provisions of the NSSP. Only
those firms that comply with the NSSP
would be permitted to export molluscan
shellfish to a country whose competent
authority determined that the U.S.
system of controls is equivalent to their
own controls. If approved, FDA will use
this information to support the export of
U.S. shellfish to countries whose
competent authorities have determined
the U.S. system of food safety controls
to be equivalent to their own system of
controls by demonstrating that the
exporter is in compliance with the U.S.
system of controls specified in the
NSSP.
For example, to implement the
European Commission’s (EC)
determination that the U.S. system of
food safety controls for raw bivalve
molluscan shellfish is equivalent to the
European Union’s (EU) system of
controls, the EC is requiring FDA to
provide documentation collected from
NSSP-participating shellfish control
authorities with firms seeking to export
raw molluscan shellfish to the EU. This
documentation includes, but is not
limited to:
• A list of growing areas with an
Approved classification;
• the most recent sanitary survey for
each growing area with an Approved
classification; and
• the most recent inspection report
for each firm seeking to export shellfish
to the EU.
The examples above are illustrative.
Some competent authorities may require
additional information to conduct an
equivalence assessment or to implement
an equivalence determination, or both.
We plan to provide respondents with
information about the specific
documentation that is required for each
equivalence assessment. For those
competent authorities that recognize the
U.S. system as equivalent, additional
documentation may be needed to
implement that determination.
Description of Respondents:
Respondents to this collection are
participating State and local regulatory
agencies and foreign nations.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Form FDA
No.
Activity
Number of
responses
per
respondent
Average
burden per
response
Total annual
responses
Total hours
Submission of Interstate Shellfish Dealer’s Certificate ....................
Submission of Other Records Related to Participation in the
NSSP.
3038
N/A
40
13
57
1
2,280
13
0.10 (6 minutes) .........
0.25 (15 minutes) .......
228
3.25
Total ..........................................................................................
....................
....................
....................
....................
.....................................
231.25
1 There
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 certificates received in the
past 3 years, which has remained
constant.
Dated: October 28, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–24063 Filed 11–3–21; 8:45 am]
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Number of
respondents
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Biodefense Science Board
Office of the Assistant
Secretary for Preparedness and
Response (ASPR), Department of Health
and Human Services (HHS).
AGENCY:
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ACTION:
Notice.
The National Biodefense
Science Board (NBSB or the Board) is
authorized under Section 319M of the
Public Health Service (PHS) Act, as
added by section 402 of the Pandemic
and All-Hazards Preparedness Act of
2006 and amended by section 404 of the
Pandemic and All-Hazards
Preparedness Reauthorization Act. The
Board is governed by the Federal
Advisory Committee Act (5 U.S.C. app.),
which sets forth standards for the
formation and use of advisory
committees. The NBSB provides expert
advice and guidance on scientific,
technical, and other matters of special
interest to the Department of Health and
Human Services (HHS) regarding
current and future chemical, biological,
nuclear, and radiological agents,
whether naturally occurring, accidental,
or deliberate. Authority to manage and
operate the NBSB, including to receive
SUMMARY:
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advice and recommendations from the
Board, has been delegated by the
Secretary of HHS to the Assistant
Secretary for Preparedness and
Response (ASPR). The NBSB will meet
in public (virtually) on December 16,
2021, to provide advice and
recommendations to ASPR regarding the
development of the 2023–2026 National
Health Security Strategy and to discuss
other matters of current important for
public health emergency preparedness,
response, and recovery. A more detailed
agenda will be available on the NBSB
meeting website https://www.phe.gov/
nbsb.
Procedures for Public Participation:
Members of the public may attend the
meeting via a toll-free phone number or
Zoom teleconference, which requires
pre-registration. The meeting link to
pre-register will be posted on the
meeting website https://www.phe.gov/
nbsb. Members of the public may
provide written comments or submit
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Federal Register / Vol. 86, No. 211 / Thursday, November 4, 2021 / Notices
questions for consideration by the NBSB
at any time via email to NBSB@hhs.gov.
Additionally, the NBSB invites those
who are involved in or represent a
relevant biodefense or health security
industry, serve as faculty or conduct
research at an academic institution,
occupy a relevant health profession, or
work for a hospital system or health care
consumer organization; or those who
serve in a state, Tribal, territorial or
local government agency to request up
to seven minutes to address the Board
in person via Zoom. Requests to provide
remarks to the NBSB during the public
meeting must be sent to NBSB@hhs.gov
by midnight on October 10, 2021. In that
request, please provide the name, title,
and position of the individual who will
be speaking and a brief description of
the planned topic. Presenters who are
selected for the public meeting will
have audio only during the meeting,
thoughlides, documents, and other
presentation material may be sent
ahead; those will be provided directly to
the board members. Topics and
presentations with an obvious
commercial bias, to include any form of
advertising, marketing, or solicitation,
will not be accepted.
FOR FURTHER INFORMATION CONTACT:
CAPT Christopher L. Perdue, MD, MPH,
(202) 480–7226, NBSB Designated
Federal Officer, Washington, DC, Office
NBSB@hhs.gov.
Dawn O’Connell,
Assistant Secretary for Preparedness and
Response.
[FR Doc. 2021–23971 Filed 11–3–21; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
Domestic Violence Prevention:
Forensic Healthcare Services
Announcement Type: New.
Funding Announcement Number:
HHS–2022–IHS–FHC–0001.
Assistance Listing (Catalog of Federal
Domestic Assistance or CFDA) Number:
93.653.
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Key Dates
Application Deadline Date: February
2, 2022.
Earliest Anticipated Start Date: March
21, 2022.
I. Funding Opportunity Description
Statutory Authority
The Indian Health Service (IHS) is
accepting applications for grants that
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will develop and/or expand Forensic
Healthcare (FHC) services. This program
was first established by the Omnibus
Appropriations Act of 2009, Public Law
111–8, 123 Stat. 524, 735, as a
component of the Domestic Violence
Prevention Initiative, and continued in
the annual appropriations acts since
that time. This program is authorized
under the Snyder Act, 25 U.S.C. 13; and
the Indian Health Care Improvement
Act, 25 U.S.C. 1665a, 1665m. This
program is described in the Assistance
Listings located at https://sam.gov/
content/home (formerly known as
Catalog of Federal Domestic Assistance)
under 93.653.
Background
The Division of Behavioral Health
(DBH) serves as the primary source of
national advocacy, policy development,
management and administration of
behavioral health, alcohol and
substance abuse, and family violence
prevention programs. Domestic and
sexual violence including child
maltreatment are a public health
concern among the American Indian/
Alaska Native (AI/AN) population.
American Indians and Alaska Natives
experience high rates of sexual violence
according to a 2016 publication from the
Department of Justice. Previously,
forensic health care functions were
funded under Purpose Area 2 of the
Domestic Violence Prevention (DVP)
program, formerly known as the
Domestic Violence Prevention Initiative.
This announcement separates forensic
health care functions into a distinct
program. The FHC program will address
access to health care needed for AI/AN
victims of domestic and sexual violence.
The IHS supports comprehensive efforts
to develop and/or expand FHC services
to provide treatment, intervention, and
prevention in order to address the needs
of victims impacted by domestic
violence, sexual assault, stalking, sexual
exploitation/human trafficking, and
child maltreatment. The FHC program is
aligned with the national DVP goals,
https://www.ihs.gov/dvpi/aboutdvp/.
Purpose
The purpose of this IHS grant is to
provide access to treatment for AI/AN
victims of domestic and sexual violence
by supporting the development of and/
or expansion of FHC services that are
culturally appropriate and traumainformed. The intent is to impact FHC
services in each IHS Area (provided by
Tribes, Tribal organizations and Urban
Indian organizations). This also
includes promoting treatment,
intervention, and prevention efforts for
the social, spiritual, and emotional well-
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60843
being of victims, including victims of
child maltreatment. To address
domestic and sexual violence, including
victims of sexual exploitation/human
trafficking, applicants are encouraged to
use Multidisciplinary Team (MDT) and
Sexual Assault Response Team (SART)
approaches. Using these types of team
approaches is crucial—especially among
local, state, and Federal agencies that
includes health care providers, law
enforcement, child protective services,
social services, legal services, domestic
violence coalitions, behavioral health
services, and victim advocacy. The
MDT/SART are community-based
approaches in responding to sexual
assault, intimate partner violence, and
sexual abuse victims. Without the
advantage of a team approach method,
a program is more likely to fail.
Improving collaboration through formal
inter-agency agreements can improve
the response time for sexual assault
victims.
II. Award Information
Funding Instrument—Grant
Estimated Funds Available
The total funding identified for fiscal
year (FY) 2022 is approximately
$2,500,000. Individual award amounts
for the first budget year are anticipated
to be $250,000. The funding available
for competing and subsequent
continuation awards issued under this
announcement is subject to the
availability of appropriations and
budgetary priorities of the agency. The
IHS is under no obligation to make
awards that are selected for funding
under this announcement.
Anticipated Number of Awards
Approximately 10 awards will be
issued under this program
announcement with up to one award set
aside for an eligible Urban Indian
organization.
Period of Performance
The period of performance is for 5
years.
III. Eligibility Information
1. Eligibility
To be eligible for this new FY 2022
funding opportunity, applicants must be
one of the following as defined by 25
U.S.C. 1603:
• A federally recognized Indian Tribe
as defined by 25 U.S.C. 1603(14). The
term ‘‘Indian Tribe’’ means any Indian
Tribe, band, nation, or other organized
group or community, including any
Alaska Native village or group, or
regional or village corporation as
defined in or established pursuant to the
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]]>Agencies
[Federal Register Volume 86, Number 211 (Thursday, November 4, 2021)]
[Notices]
[Pages 60842-60843]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-23971]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Biodefense Science Board
AGENCY: Office of the Assistant Secretary for Preparedness and Response
(ASPR), Department of Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The National Biodefense Science Board (NBSB or the Board) is
authorized under Section 319M of the Public Health Service (PHS) Act,
as added by section 402 of the Pandemic and All-Hazards Preparedness
Act of 2006 and amended by section 404 of the Pandemic and All-Hazards
Preparedness Reauthorization Act. The Board is governed by the Federal
Advisory Committee Act (5 U.S.C. app.), which sets forth standards for
the formation and use of advisory committees. The NBSB provides expert
advice and guidance on scientific, technical, and other matters of
special interest to the Department of Health and Human Services (HHS)
regarding current and future chemical, biological, nuclear, and
radiological agents, whether naturally occurring, accidental, or
deliberate. Authority to manage and operate the NBSB, including to
receive advice and recommendations from the Board, has been delegated
by the Secretary of HHS to the Assistant Secretary for Preparedness and
Response (ASPR). The NBSB will meet in public (virtually) on December
16, 2021, to provide advice and recommendations to ASPR regarding the
development of the 2023-2026 National Health Security Strategy and to
discuss other matters of current important for public health emergency
preparedness, response, and recovery. A more detailed agenda will be
available on the NBSB meeting website https://www.phe.gov/nbsb.
Procedures for Public Participation: Members of the public may
attend the meeting via a toll-free phone number or Zoom teleconference,
which requires pre-registration. The meeting link to pre-register will
be posted on the meeting website https://www.phe.gov/nbsb. Members of
the public may provide written comments or submit
[[Page 60843]]
questions for consideration by the NBSB at any time via email to
[email protected].
Additionally, the NBSB invites those who are involved in or
represent a relevant biodefense or health security industry, serve as
faculty or conduct research at an academic institution, occupy a
relevant health profession, or work for a hospital system or health
care consumer organization; or those who serve in a state, Tribal,
territorial or local government agency to request up to seven minutes
to address the Board in person via Zoom. Requests to provide remarks to
the NBSB during the public meeting must be sent to [email protected] by
midnight on October 10, 2021. In that request, please provide the name,
title, and position of the individual who will be speaking and a brief
description of the planned topic. Presenters who are selected for the
public meeting will have audio only during the meeting, thoughlides,
documents, and other presentation material may be sent ahead; those
will be provided directly to the board members. Topics and
presentations with an obvious commercial bias, to include any form of
advertising, marketing, or solicitation, will not be accepted.
FOR FURTHER INFORMATION CONTACT: CAPT Christopher L. Perdue, MD, MPH,
(202) 480-7226, NBSB Designated Federal Officer, Washington, DC, Office
[email protected].
Dawn O'Connell,
Assistant Secretary for Preparedness and Response.
[FR Doc. 2021-23971 Filed 11-3-21; 8:45 am]
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