Federal Register / Vol. 86, No. 150 / Monday, August 9, 2021 / Notices 43549 

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, selfdetermination, 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/publicinput. 

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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