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 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 86, No. 150 / Monday, August 9, 2021 / Notices 43551 

investigation by a State agency of 

complaints relating to compounded 

drug products distributed outside such 

State; or (2) if the drug product is 

compounded in a State that has not 

entered into such an MOU, the licensed 

pharmacist, pharmacy, or physician 

does not distribute, or cause to be 

distributed, compounded drug products 

out of the State in which they are 

compounded in quantities that exceed 5 

percent of the total prescription orders 

dispensed or distributed by such 

pharmacy or physician (statutory 5 

percent limit) (see section 

503A(b)(3)(B)(i) and (ii) of the FD&C 

Act). 

In the Federal Register of October 27, 

2020 (85 FR 68074), FDA announced the 

availability of the final standard MOU 

describing the responsibilities of a State 

Board of Pharmacy or other appropriate 

State agency that chooses to sign the 

final standard MOU in investigating and 

responding to complaints related to 

drug products compounded in such 

State and distributed outside such State 

and in addressing the interstate 

distribution of inordinate amounts of 

compounded human drug products. 

In the October 27, 2020, Federal 

Register notice, FDA stated that it was 

providing a 365-day period for States to 

decide whether to sign the final 

standard MOU before FDA intended to 

begin enforcing the statutory 5 percent 

limit in States that do not sign the final 

standard MOU. Based on comments 

from stakeholders, it was FDA’s 

understanding that this timeframe 

corresponds to a full legislative cycle for 

most States and would, therefore, afford 

sufficient time for States to modify their 

laws and regulations, if necessary in 

order to enter into the final standard 

MOU. 

Following publication of October 27, 

2020, Federal Register notice, FDA 

received requests to extend the period 

before FDA intends to begin enforcing 

the statutory 5 percent limit in States 

that do not sign. The requesters asserted 

that the time period of 365 days was 

insufficient to allow State governments 

to thoroughly evaluate the final 

standard MOU and modify their laws 

and regulations, if necessary in order to 

sign, because many State governments 

were focused on addressing concerns 

raised by the Coronavirus Disease 2019 

(COVID–19) pandemic. 

FDA has considered the requests and 

other relevant factors and is extending 

the period before FDA intends to begin 

enforcing the statutory 5 percent limit in 

States that do not sign the final standard 

MOU until October 27, 2022. FDA 

believes that an additional 1 year will 

allow sufficient time for States to 

consider the final standard MOU and 

modify their laws and regulations, if 

necessary. FDA’s understanding is that 

emergency pandemic response activities 

have now begun to ease, permitting 

States more time to take up other issues. 

Accordingly, we believe a 1-year 

extension addresses the need that some 

States have expressed for additional 

time, without adding significant delay 

to FDA’s implementation of the 

important public health protections 

afforded by section 503A(b)(3)(B) of the 

FD&C Act. 

States may sign the final standard 

MOU at any time, including after the 

period is scheduled to end on October 

27, 2022. 

Dated: August 4, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–16937 Filed 8–6–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–D–3931] 

Nonmetastatic Castration-Resistant 

Prostate Cancer: Considerations for 

Metastasis-Free Survival Endpoint in 

Clinical Trials; Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a final 

guidance for industry entitled 

‘‘Nonmetastatic Castration-Resistant 

Prostate Cancer: Considerations for 

Metastasis-Free Survival Endpoint in 

Clinical Trials.’’ Recent approvals of 

several drug products for patients with 

nonmetastatic castration-resistant 

prostate cancer have been supported by 

randomized clinical trials 

demonstrating improvements in 

metastasis-free survival. This guidance 

intends to inform potential future 

applicants regarding the Agency’s 

expectations for collection, analysis, 

and reporting of data pertaining to 

metastasis-free survival. This guidance 

finalizes the draft guidance of the same 

title issued on November 14, 2018. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on August 9, 2021. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time as 

follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2018–D–3931 for ‘‘Nonmetastatic 

Castration-Resistant Prostate Cancer: 

Considerations for Metastasis-Free 

Survival Endpoint in Clinical Trials.’’ 

Received comments will be placed in 

the docket and, except for those 

submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 


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