Agency Information Collection Activities; Proposed Collection; Public Comment Request; Centers for Independent Living Program Performance Report (0985-0061)
| Published date | 09 August 2021 |
| Citation | 86 FR 43549 |
| Record Number | 2021-16752 |
| Section | Notices |
| Court | Community Living Administration,Health And Human Services Department |
43549
Federal Register / Vol. 86, No. 150 / Monday, August 9, 2021 / Notices
functions of the Advisory Board include
providing advice on the development of
probability of causation guidelines that
have been promulgated by the
Department of Health and Human
Services (HHS) as a final rule; advice on
methods of dose reconstruction, which
have also been promulgated by HHS as
a final rule; advice on the scientific
validity and quality of dose estimation
and reconstruction efforts being
performed for purposes of the
compensation program; and advice on
petitions to add classes of workers to the
Special Exposure Cohort (SEC). In
December 2000, the President delegated
responsibility for funding, staffing, and
operating the Advisory Board to HHS,
which subsequently delegated this
authority to CDC. NIOSH implements
this responsibility for CDC.
The Advisory Board’s charter was
issued on August 3, 2001, renewed at
appropriate intervals, and rechartered
under Executive Order 13889 on March
22, 2020, and will terminate on March
22, 2022.
Purpose: The Advisory Board is
charged with (a) providing advice to the
Secretary, HHS, on the development of
guidelines under Executive Order
13179; (b) providing advice to the
Secretary, HHS, on the scientific
validity and quality of dose
reconstruction efforts performed for this
program; and (c) upon request by the
Secretary, HHS, advise the Secretary on
whether there is a class of employees at
any Department of Energy facility who
were exposed to radiation but for whom
it is not feasible to estimate their
radiation dose, and on whether there is
reasonable likelihood that such
radiation doses may have endangered
the health of members of this class.
SDRR was established to aid the
Advisory Board in carrying out its duty
to advise the Secretary, HHS, on dose
reconstruction.
Matters To Be Considered: The agenda
will include discussions on the
following dose reconstruction program
quality management and assurance
activities: Dose reconstruction cases
under review from Set 29, possibly
including cases involving: Albuquerque
Operations Office, Area IV of the Santa
Susana Field Laboratory, Argonne
National Laboratory-East, Argonne
National Laboratory-West, Battelle
Laboratories-King Avenue, Clarksville
Modification Center, Feed Materials
Production Center (FMPC), Fermi
National Accelerator Laboratory,
General Atomics, Hanford, Idaho
National Laboratory, Lawrence Berkeley
National Laboratory, Lawrence
Livermore National Laboratory, Los
Alamos National Laboratory, Mound
Plant, Nevada Test Site, Oak Ridge
Gaseous Diffusion Plant (K–25), Oak
Ridge Institute for Science and
Education, Oak Ridge National
Laboratory (X–10), Pacific Northwest
National Laboratory, Paducah Gaseous
Diffusion Plant, Pantex Plant,
Portsmouth Gaseous Diffusion Plant,
Rocky Flats Plant, Savannah River Site,
and/or Y–12 Plant. If time permits, there
may also be discussion on professional
judgement in response to the April 12,
2021 SDRR report to the Advisory
Board. Agenda items are subject to
change as priorities dictate.
The Director, Strategic Business
Initiatives Unit, Office of the Chief
Operating Officer, Centers for Disease
Control and Prevention, has been
delegated the authority to sign Federal
Register notices pertaining to
announcements of meetings and other
committee management activities, for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Kalwant Smagh,
Director, Strategic Business Initiatives Unit,
Office of the Chief Operating Officer, Centers
for Disease Control and Prevention.
[FR Doc. 2021–16954 Filed 8–6–21; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Community Living
Agency Information Collection
Activities; Proposed Collection; Public
Comment Request; Centers for
Independent Living Program
Performance Report (0985–0061)
AGENCY
: Administration for Community
Living, Health and Human Services
(HHS).
ACTION
: Notice.
SUMMARY
: The Administration for
Community Living (ACL) is announcing
an opportunity for the public to
comment on the proposed collection of
information listed above. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish a notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This Proposed Extension
without Revision of a Currently
Approved Collection (ICR Ext) solicits
comments on the information collection
requirements relating to the Centers for
Independent Living under the
Rehabilitation Act of 1973.
DATES
: Comments on the collection of
information must be submitted
electronically by 11:59 p.m. (EST) or
postmarked by October 8, 2021.
ADDRESSES
: Submit electronic
comments on the collection of
information to: Peter Nye at
OILPPRAComments@acl.hhs.gov.
Submit written comments on the
collection of information to
Administration for Community Living,
Washington, DC 20201, Attention: Peter
Nye.
FOR FURTHER INFORMATION CONTACT
:
Peter Nye, Administration for
Community Living, Washington, DC
20024, (202) 795–7606 or
OILPPRAComments@acl.hhs.gov.
SUPPLEMENTARY INFORMATION
: Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, ACL is publishing a notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, ACL invites
comments on our burden estimates or
any other aspect of this collection of
information, including:
(1) Whether the proposed collection
of information is necessary for the
proper performance of ACL’s functions,
including whether the information will
have practical utility;
(2) the accuracy of ACL’s estimate of
the burden of the proposed collection of
information, including the validity of
the methodology and assumptions used
to determine burden estimates; (3) ways
to enhance the quality, utility, and
clarity of the information to be
collected; and
(4) ways to minimize the burden of
the collection of information on
respondents, including through the use
of automated collection techniques
when appropriate, and other forms of
information technology.
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43550
Federal Register / Vol. 86, No. 150 / Monday, August 9, 2021 / Notices
In the context of ACL, IL programs are
supported through funding authorized
by the Rehabilitation Act of 1973, as
amended (The Act). Title VII, chapter 1
of the Act states the current purpose of
the program is to ‘‘promote a
philosophy of independent living
including a philosophy of consumer
control, peer support, self-help, self-
determination, equal access, and
individual and system advocacy, in
order to maximize the leadership,
empowerment, independence, and
productivity of individuals with
disabilities, and the integration and full
inclusion of individuals with
disabilities into the mainstream of
American society.’’
ILS PPR and CIL PPR are being
submitted separately because they are
separate collections of different
information from different parties.
Separating these PRA processes reduces
confusion and increases the Office of
Independent Living Programs’s (OILP’s)
ability to identify issues specific to CILs.
This request is for CIL PPR, which is
submitted annually by all CILs receiving
IL Part C funds. The PPRs are used by
ACL to assess grantees’ compliance with
title VII of the Act, and with 45 CFR
1329 of the Code of Federal Regulations
and with applicable provisions of the
HHS Regulations at 45 CFR part 75. The
PPR serves as the primary basis for
ACL’s monitoring activities in
fulfillment of its responsibilities under
sections 706 and 722 of the Act. The
PPR also enables ACL to track
performance outcomes and efficiency
measures of the Centers for Independent
Living (CIL) programs with respect to
the annual and long-term performance
targets established in compliance with
GPRA. The PPR is also used by ACL to
design CIL and SILC training and
technical assistance programs
authorized by section 711A and section
721 of the Act.
ACL published a Federal Register
Notice regarding the independent living
programs information collection on
February 23, 2017. Two-hundred and
twenty-one individual comments were
received. The responses indicated a
need to make substantial changes to the
collection. The current version of the
CIL PPR that OILP is requesting an
extension for was approved by OMB;
the approval was extended and will
expire on January 31, 2022. Further
deliberation is needed to ensure that we
appropriately address all of the
concerns. OILP is proposing to extend
the currently approved forms for one
year while we work on a revision that
addresses all the suggested changes. The
proposed data collection tools may be
found on the ACL website for review at
https://www.acl.gov/about-acl/public-
input.
Estimated Program Burden
ACL estimates the burden of this
collection of information as follows: 353
Centers for Independent Living will
each complete one CIL PPR annually,
and it will take an estimated 35 hours
per CIL for an estimated total of 12,355
hours. This burden estimate is based
partly on OILP’s estimates of how long
CILs probably take to find the
information that PPRs ask for and partly
on what CILs have told OILP about how
long filling out the PPRs took.
Respondent/data collection activity Number of
respondents
Responses
per
respondent
Hours per
response Annual burden
hours
Centers for Independent Living ....................................................................... 353 1 35 12,355
Dated: July 29, 2021.
Alison Barkoff,
Acting Administrator and Assistant Secretary
for Aging.
[FR Doc. 2021–16752 Filed 8–6–21; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–0030]
Extension of the Period Before the
Food and Drug Administration Intends
To Begin Enforcing the Statutory 5
Percent Limit on Out of State
Distribution of Compounded Human
Drug Products
AGENCY
: Food and Drug Administration,
Health and Human Services (HHS).
ACTION
: Notice; extension of the period
before FDA intends to begin enforcing
the statutory 5 percent limit on out of
state distribution of compounded
human drug products.
SUMMARY
: The Food and Drug
Administration (FDA or the Agency) is
extending the period for States to decide
whether to sign the final standard
memorandum of understanding (MOU)
entitled ‘‘Memorandum of
Understanding Addressing Certain
Distributions of Compounded Human
Drug Products Between the [insert State
Board of Pharmacy or Other
Appropriate State Agency] and the U.S.
Food and Drug Administration’’ (final
standard MOU) before FDA intends to
begin enforcing the statutory 5 percent
limit on distribution of compounded
human drug products out of the State in
which they are compounded in States
that do not sign the final standard MOU.
FDA is extending the period, which was
scheduled to end on October 27, 2021,
to October 27, 2022. States may sign the
final standard MOU at any time,
including after the period is scheduled
to end on October 27, 2022.
DATES
: FDA is extending the period
before FDA intends to begin enforcing
the statutory 5 percent limit on
distribution of compounded human
drug products out of the State in which
they are compounded in States that do
not sign the final standard MOU as of
August 9, 2021.
FOR FURTHER INFORMATION CONTACT
:
Alexandria Fujisaki, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 5169,
Silver Spring, MD 20993–0002, 240–
402–4078.
SUPPLEMENTARY INFORMATION
: Section
503A of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
353a) describes the conditions that must
be satisfied for drug products
compounded by a licensed pharmacist
or licensed physician in a State licensed
pharmacy or a Federal facility, to be
exempt from the following sections of
the FD&C Act: (1) Section 501(a)(2)(B)
(21 U.S.C. 351(a)(2)(B)) (concerning
current good manufacturing practice
(CGMP) requirements), (2) section
502(f)(1) (21 U.S.C. 352(f)(1))
(concerning the labeling of drugs with
adequate directions for use), and (3)
section 505 (21 U.S.C. 355) (concerning
the approval of drugs under new drug
applications or abbreviated new drug
applications).
One of the conditions to qualify for
the exemptions listed in section 503A of
the FD&C Act is that (1) the drug
product is compounded in a State that
has entered into an MOU with FDA that
addresses the distribution of inordinate
amounts of compounded drug products
interstate and provides for appropriate
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