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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 Programss OILPs 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
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 OILPs 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. 202116752 Filed 8621; 8:45 am BILLING CODE 415401P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration Docket No. FDA2015N0030

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 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.
AGENCY:

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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 ACLs 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
The Food and Drug Administration FDA or the Agency is extending the period for States to decide
SUMMARY:

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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
PO 00000

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Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 5169, Silver Spring, MD 209930002, 240
4024078.
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 501a2B
21 U.S.C. 351a2B concerning current good manufacturing practice CGMP requirements, 2 section 502f1 21 U.S.C. 352f1
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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