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Federal Register / Vol. 86, No. 150 / Monday, August 9, 2021 / Notices 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 503Ab3Bi 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 FDAs 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
COVID19 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
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consider the final standard MOU and modify their laws and regulations, if necessary. FDAs 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 FDAs implementation of the important public health protections afforded by section 503Ab3B 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. 202116937 Filed 8621; 8:45 am BILLING CODE 416401P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration Docket No. FDA2018D3931

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.

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 Agencys 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 SUMMARY:

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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 elses 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 HFA305, 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
2018D3931 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, 2404027500.
Confidential SubmissionsTo 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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