60 Day FRN Black Lung Clinics Program

Federal Register / Vol. 86, No. 91 / Thursday, May 13, 2021 / Notices
consequences of proposed actions, and
any reasonable alternatives. Under FDA
regulations, FDA will prepare an EIS
when data or information in an
environmental assessment or otherwise
available to the Agency leads to a
finding that the proposed agency action
may significantly affect the quality of
the human environment.2 Because of
questions raised about the extent to
which two sunscreen active ingredients
(oxybenzone and octinoxate) may affect
coral and/or coral reefs, FDA is
initiating the public scoping process to
consider any potential environmental
impacts associated with the use of
oxybenzone and octinoxate in
sunscreens so that an EIS, if necessary,
can be completed prior to issuance of a
final sunscreen order addressing
sunscreens containing these ingredients.
We note the Agency’s docket to the
2019 proposed rule ‘‘Sunscreen Drug
Products for Over-the-Counter Human
Use’’ (84 FR 6204 February 26, 2019)
received comments that raised concerns
about the potential impacts from
sunscreens containing oxybenzone or
octinoxate on coral and/or coral reefs.
FDA is also aware that the National
Oceanic and Atmospheric
Administration (NOAA) Coral Reef
Conservation Program is currently
evaluating research related to coral reef
health, including the potential impacts
of sunscreen products that include
oxybenzone and octinoxate on coral
reefs and other aquatic systems.3 The
Agency is also aware that at least one
state has restricted the sale of
sunscreens that include the active
ingredients oxybenzone or octinoxate.
On July 3, 2018, the state of Hawaii
signed into law S. 2571, Act 104,
prohibiting the sale, offer of sale, and
distribution of sunscreens that contain
oxybenzone and/or octinoxate, to
protect Hawaii’s marine ecosystems,
including coral reefs. This law became
effective January 1, 2021. All of these
actions raise questions about the
potential environmental impacts of
sunscreens containing oxybenzone and/
or octinoxate on coral and/or coral reefs
that warrant further evaluations.
The purpose of the public scoping
process is to determine relevant issues
that will influence the scope of the
environmental analysis, including
potential alternatives and the extent to
which those issues and impacts will be
analyzed. At this initial stage of the
2 See

21 CFR 25.22(b); 40 CFR 1508.27.
NOAA’s Coral Reef Information article ‘‘The
effects of ultraviolet filters and sunscreen on corals
and aquatic ecosystems,’’ available at the NOAA
web page https://www.coris.noaa.gov/activities/
effects-ultraviolet-filters-sunscreen-corals/
welcome.html.
3 See

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scoping process, we have identified the
following four alternatives: (1) FDA will
conclude that the inclusion of
oxybenzone and octinoxate in
sunscreens marketed without an NDA is
impermissible; (2) FDA will conclude
that the inclusion of oxybenzone and
octinoxate in sunscreens marketed
without an NDA is permissible; (3) FDA
will conclude that inclusion of
oxybenzone in sunscreens marketed
without an NDA is permissible but that
the inclusion of octinoxate in
sunscreens marketed without an NDA is
impermissible; or (4) FDA will conclude
that inclusion of octinoxate in
sunscreens marketed without an NDA is
permissible but that the inclusion of
oxybenzone in sunscreens marketed
without an NDA is impermissible.
The EIS will be prepared in
accordance with section 102(2)(C) of
NEPA, 42 U.S.C. 4332(2)(C), FDA’s
NEPA implementing regulations (21
CFR part 25), and the CEQ regulations
for implementing NEPA (40 CFR parts
1500–1508).4 Federal, State, and local
agencies, along with Tribes and other
stakeholders that may be interested in or
affected by the sunscreen proposed
order are invited to participate in the
scoping process. Some Federal agencies
may request or be requested by the FDA
to participate in the development of the
environmental analysis as a cooperating
agency. FDA encourages other
stakeholders to comment on this
scoping process, on what specific
issues, alternatives, mitigation
measures, or other information FDA
should include for further analysis in
the EIS.
Dated: May 7, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–10091 Filed 5–12–21; 8:45 am]
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4 FDA began activities relating to the
environmental assessment of the use of oxybenzone
and octinoxate in sunscreens marketed without an
NDA before September 14, 2020. Consistent with 40
CFR 1506.13, FDA will apply the regulations in
place prior to implementation of the new CEQ
regulations. See the Council on Environmental
Quality’s final rule, ‘‘Update to the Regulations
Implementing the Procedural Provisions of the
National Environmental Policy Act’’ (40 CFR
1506.13, 85 FR 43304 at 43372 (July 16, 2020)).

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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request; Information
Collection Request Title: Black Lung
Clinics Program, OMB No. 0915–
0292—Revision
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:

In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects of the Paperwork Reduction Act
of 1995, HRSA announces plans to
submit an Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB). Prior to submitting the ICR to
OMB, HRSA seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the ICR.
DATES: Comments on this ICR should be
received no later than July 12, 2021.
ADDRESSES: Submit your comments to
[email protected] or mail the HRSA
Information Collection Clearance
Officer, Room 14N136B, 5600 Fishers
Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email [email protected]
or call Lisa Wright-Solomon, the HRSA
Information Collection Clearance Officer
at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the ICR title
for reference.
Information Collection Request Title:
Black Lung Clinics Program
Performance Measures, OMB No. 0915–
0292—Revision.
Abstract: HRSA’s Federal Office of
Rural Health Policy conducts an annual
data collection of user information for
the Black Lung Clinics Program (BLCP),
which has been ongoing with OMB
approval since 2004. The BLCP is
authorized by Sec. 427(a) of the Federal
Mine Safety and Health Act of 1977, as
amended (30 U.S.C. 937), and
accompanying regulations at 42 CFR
part 55a, to reduce the morbidity and
mortality associated with
occupationally-related coal mine dust
lung disease through the screening,
diagnosis, and treatment of active,
inactive, retired, and/or disabled coal
SUMMARY:

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Federal Register / Vol. 86, No. 91 / Thursday, May 13, 2021 / Notices

miners. Collecting this data provides
HRSA with information on how well
each grantee is meeting the needs of
these miners in their communities.
Need and Proposed Use of the
Information: Data from the annual
performance measures report provides
quantitative information about the
clinics, specifically: (a) The
characteristics of the patients they serve
(age, diagnoses, occupation type); (b) the
characteristics of services provided
(clinical services and benefits
counseling); and (c) the number of
patients served. This programmatic
performance measure enables HRSA to
provide data required by Congress
under the Government Performance and
Results Act of 1993. It also ensures that

funds are effectively used to provide
services that meet the target population
needs.
The proposed changes to the BLCP
measures are a result of the
accumulation of grantee and stakeholder
feedback and information gathered from
the previously approved BLCP
measures. The proposed changes
include revisions of current measures
for better usability and additional
questions about screening program
participation, smoking, pulmonary
function testing, referral for services,
and COVID–19 vaccination.
Likely Respondents: Respondents will
likely be award recipients of the Black
Lung Clinics Program.
Burden Statement: Burden in this
context means the time expended by

persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install, and utilize
technology and systems for the purpose
of collecting, validating, and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.

TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Form name

Number of
responses per
respondent

Average
burden per
response
(in hours)

Total
responses

Total
burden
hours

Black Lung Clinics Program Measures ...............................

15

1

15

10

150

Total ..............................................................................

15

........................

15

........................

150

HRSA specifically requests comments
on (1) the necessity and utility of the
proposed information collection for the
proper performance of the agency’s
functions, (2) the accuracy of the
estimated burden, (3) ways to enhance
the quality, utility, and clarity of the
information to be collected, and (4) the
use of automated collection techniques
or other forms of information
technology to minimize the information
collection burden.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2021–10087 Filed 5–12–21; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Advisory Committee on
Individuals With Disabilities and
Disasters
Office of the Assistant
Secretary for Preparedness and
Response (ASPR), Department of Health
and Human Services (HHS).
ACTION: Notice.
AGENCY:

The Office of the Assistant
Secretary for Preparedness and
Response (ASPR), in the Department of
Health and Human Services (HHS)
Office of the Secretary announces
establishment of the National Advisory

SUMMARY:

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Committee on Individuals with
Disabilities and Disasters (NACIDD).
The Advisory Committee will provide
advice and consultation to the HHS
Secretary with respect to the medical,
public health, and accessibility needs of
individuals with disabilities related to
preparation for, response to, and
recovery from all-hazards emergencies.
The Office of the Assistant Secretary for
Preparedness and Response (ASPR)
shall provide management and
administrative oversight to support the
activities of the Advisory Committee.
The Office of the Secretary is accepting
application submissions from qualified
individuals who wish to be considered
for membership on the NACIDD. Up to
seven voting members with expertise
disability accessibility, disaster
planning, preparedness, response, or
recovery will be selected for the
Committee. Please visit the NACIDD
website at www.phe.gov/nacidd for all
application submission information and
instructions. Application submissions
will be accepted for 30 calendar days
from the date this posting is published
in the Federal Register.
DATES: Application Period: The
application submissions will be
accepted for 30 calendar days from the
date this posting is published in the
Federal Register.
FOR FURTHER INFORMATION CONTACT:
Maxine Kellman, DVM, Ph.D., PMP,

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Alternate Designated Federal Official for
National Advisory Committees,
Washington, DC, Office (202) 260–0447
or email [email protected].
The Office
of the Assistant Secretary for
Preparedness and Response provides
management and administrative
oversight to support the activities of the
NACIDD.
Description of Duties: The NACIDD
shall evaluate issues and programs and
provide findings, advice, and
recommendations to the Secretary of
HHS, in accordance with FACA, to
support and enhance all-hazards public
health and medical preparedness,
response activities, and recovery aimed
at meeting the unique needs of
individuals with disabilities across the
entire spectrum of their wellbeing. The
NACIDD shall (1) provide advice and
consultation with respect to activities
carried out pursuant to section 2814 of
the PHS Act (at-risk individuals), as
applicable and appropriate; (2) evaluate
and provide input with respect to the
medical, public health, and accessibility
needs of individuals with disabilities
related to preparation for, response to,
and recovery from all-hazards
emergencies; and (3) provide advice and
consultation with respect to State
emergency preparedness and response
activities, including related drills and
exercises pursuant to the preparedness

SUPPLEMENTARY INFORMATION:

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