Premenopausal Women With Breast Cancer: Developing Drugs for Treatment; Guidance for Industry; Availability, 33313-33315 [2021-13388]

Download as PDF Federal Register / Vol. 86, No. 119 / Thursday, June 24, 2021 / Notices received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240–402–7500. FOR FURTHER INFORMATION CONTACT: Lori Benner and/or Antoinette Ziolkowski, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6221, Silver Spring, MD 20993–0002, 301–796–1300. SUPPLEMENTARY INFORMATION: I. Background Progressive Multifocal Leukoencephalopathy (PML) is a rare, often fatal viral disease of the central nervous system that affects patients with immunosuppressive conditions and those treated with immunomodulatory agents. No products are approved for the treatment of PML and no therapeutic development pathway is established for PML. FDA seeks to discuss scientific and regulatory challenges associated with designing clinical trials evaluating PML treatments, and to develop PML clinical trial designs that are feasible, adequate to establish substantial evidence of effectiveness, adequate to characterize the safety profile of investigational treatments, and acceptable to PML patients, clinicians, regulators, and industry. The Agency encourages healthcare providers, employees of other U.S. Government agencies, academic experts, industry experts, patients and patient advocates, and other stakeholders to attend this public workshop. II. Topics for Discussion at the Public Workshop Discussions are planned around the following topics areas: • Unmet need for PML therapeutics. • Key trial design considerations, including feasibility, trial populations, selection of control groups, endpoints, adaptive designs, and master protocols. khammond on DSKJM1Z7X2PROD with NOTICES III. Participating in the Public Workshop Registration: Persons interested in attending this public workshop must register online by September 20, 2021, midnight Eastern Time using the weblink for this workshop noted in the Transcripts section below. Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone. VerDate Sep<11>2014 19:19 Jun 23, 2021 Jkt 253001 Requests for Oral Presentations: During online registration, you may indicate if you wish to present during the virtual public comment session and which topic(s) you wish to address. We will do our best to accommodate requests to make public comments. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations, and request time for a joint presentation, or submit requests for designated representatives to participate in the focused sessions. We will determine the amount of time allotted to each presenter and the approximate time each oral presentation is to begin, and will select and notify participants by September 10, 2021. All requests to make oral presentations must be received by September 3, 2021. If selected for presentation, any presentation materials must be emailed to the ONDPublicMTGSupport@ fda.hhs.gov no later than September 16, 2021. No commercial or promotional material will be permitted to be presented or distributed at the public workshop. Streaming webcast of the public workshop: This public workshop will be webcast at the following site: https:// collaboration.fda.gov/fdawork shop092121. If you have never attended a Connect Pro event before, test your connection at https://collaboration.fda.gov/common/ help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program, visit https://www.adobe.com/ go/connectpro_overview. FDA has verified the website addresses in this document, as of the date this document publishes in the Federal Register, but websites are subject to change over time. Transcripts: Please be advised that as soon as a transcript of the public workshop is available, it will be accessible at https:// www.regulations.gov. It may be viewed at the Dockets Management Staff (see ADDRESSES). A link to the transcript will also be available on the internet at https://www.fda.gov/drugs/news-eventshuman-drugs/considerationsprogressive-multifocalleukoencephalopathy-clinical-trialdesigns-09212021-09212021. Dated: June 15, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021–13371 Filed 6–23–21; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00108 Fmt 4703 Sfmt 4703 33313 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2020–D–1553] Premenopausal Women With Breast Cancer: Developing Drugs for Treatment; 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 ‘‘Premenopausal Women with Breast Cancer: Developing Drugs for Treatment.’’ This guidance provides recommendations regarding the inclusion of premenopausal women in breast cancer clinical trials. The guidance is intended to assist stakeholders, including sponsors and institutional review boards, responsible for the development and oversight of clinical trials for breast cancer drugs. This guidance finalizes the draft guidance of the same title issued on October 8, 2020. DATES: The announcement of the guidance is published in the Federal Register on June 24, 2021. ADDRESSES: You may submit either electronic or written comments on Agency guidances at any time as follows: SUMMARY: 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 E:\FR\FM\24JNN1.SGM 24JNN1 33314 Federal Register / Vol. 86, No. 119 / Thursday, June 24, 2021 / Notices khammond on DSKJM1Z7X2PROD with NOTICES 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– 2020–D–1553 for ‘‘Premenopausal Women with Breast Cancer: Developing Drugs for Treatment.’’ 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 submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https:// www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the VerDate Sep<11>2014 19:19 Jun 23, 2021 Jkt 253001 electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240–402–7500. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of this guidance to the Division of Drug Information, Center for Drug Evaluation and Research (CDER), Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993– 0002 or Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993– 0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Jennifer Gao, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 2135, Silver Spring, MD 20993, 240–402–4683; or Julia Beaver, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 2100, Silver Spring, MD 20993, 240–402–0489; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240–402–7911. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled ‘‘Premenopausal Women with Breast Cancer: Developing Drugs for Treatment.’’ This guidance provides recommendations regarding the inclusion of premenopausal women, as defined by serum hormonal levels (including but not limited to folliclestimulating hormone and estradiol), in breast cancer clinical trials. The issues of fertility and fertility preservation when treating premenopausal women with breast cancer are outside the scope of this guidance. Historically, premenopausal women have been excluded from some trials that have investigated the efficacy of certain drugs that rely upon PO 00000 Frm 00109 Fmt 4703 Sfmt 4703 manipulation of the hormonal axis for the treatment of hormone receptor (HR) positive breast cancer. In some cases, separate studies have been conducted to confirm the benefit in this patient population. Certain groups of drugs, such as chemotherapy, immunotherapy, and targeted therapy (which act independent of the hormonal axis), have similar efficacy in pre- and postmenopausal women with breast cancer. Based on a review of the literature, FDA believes hormonal drugs administered to premenopausal women with HR-positive breast cancer, with adequate estrogen suppression, are likely to have the same efficacy and safety profile as in postmenopausal women. The guidance encourages sponsors to discuss their breast cancer drug development plan with CDER and CBER, as applicable, early in development. The guidance recommends that menopausal status should not be the basis for exclusion from breast cancer clinical trials. The guidance includes recommendations regarding eligibility criteria and study planning and design intended to facilitate the inclusion of premenopausal women in breast cancer clinical trials. This guidance finalizes the draft guidance entitled ‘‘Premenopausal Women with Breast Cancer: Developing Drugs for Treatment’’ issued on October 8, 2020 (85 FR 63559). FDA considered comments received on the draft guidance as the guidance was finalized. Changes from the draft to the final guidance include additional recommendations on the importance of clinical studies reflecting racial and ethnic diversity and to collect patient experience data throughout the development program. Other changes include updated recommendations on collection of clinical effects as part of the clinical development program or as part of a postmarketing requirement or commitment as applicable. This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on ‘‘Premenopausal Women with Breast Cancer: Developing Drugs for Treatment.’’ It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 While this guidance contains no collection of information, it does refer to previously approved FDA collections of E:\FR\FM\24JNN1.SGM 24JNN1 Federal Register / Vol. 86, No. 119 / Thursday, June 24, 2021 / Notices information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501– 3521) is not required for this guidance. The previously approved collections of information are subject to review by OMB under the PRA. The collections of information in 21 CFR part 312 have been approved under OMB control number 0910–0014; the collections of information in 21 CFR part 314 have been approved under OMB control number 0910–0001; and the collections of information in 21 CFR part 601 have been approved under 0910–0338. III. Electronic Access Persons with access to the internet may obtain the guidance at either https://www.fda.gov/drugs/guidancecompliance-regulatory-information/ guidances-drugs, https://www.fda.gov/ vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https:// www.fda.gov/regulatory-information/ search-fda-guidance-documents, or https://www.regulations.gov. Dated: June 15, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021–13388 Filed 6–23–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration National Vaccine Injury Compensation Program; List of Petitions Received Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). ACTION: Notice. AGENCY: HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions. FOR FURTHER INFORMATION CONTACT: For information about requirements for filing petitions, and the Program in general, contact Lisa L. Reyes, Clerk of Court, United States Court of Federal khammond on DSKJM1Z7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 19:19 Jun 23, 2021 Jkt 253001 Claims, 717 Madison Place NW, Washington, DC 20005, (202) 357–6400. For information on HRSA’s role in the Program, contact the Director, National Vaccine Injury Compensation Program, 5600 Fishers Lane, Room 08N146B, Rockville, Maryland 20857; (301) 443– 6593, or visit our website at: https:// www.hrsa.gov/vaccinecompensation/ index.html. The Program provides a system of no-fault compensation for certain individuals who have been injured by specified childhood vaccines. Subtitle 2 of Title XXI of the PHS Act, 42 U.S.C. 300aa– 10 et seq., provides that those seeking compensation are to file a petition with the United States Court of Federal Claims and to serve a copy of the petition to the Secretary of HHS, who is named as the respondent in each proceeding. The Secretary has delegated this responsibility under the Program to HRSA. The Court is directed by statute to appoint special masters who take evidence, conduct hearings as appropriate, and make initial decisions as to eligibility for, and amount of, compensation. A petition may be filed with respect to injuries, disabilities, illnesses, conditions, and deaths resulting from vaccines described in the Vaccine Injury Table (the Table) set forth at 42 CFR 100.3. This Table lists for each covered childhood vaccine the conditions that may lead to compensation and, for each condition, the time period for occurrence of the first symptom or manifestation of onset or of significant aggravation after vaccine administration. Compensation may also be awarded for conditions not listed in the Table and for conditions that are manifested outside the time periods specified in the Table, but only if the petitioner shows that the condition was caused by one of the listed vaccines. Section 2112(b)(2) of the PHS Act, 42 U.S.C. 300aa–12(b)(2), requires that ‘‘[w]ithin 30 days after the Secretary receives service of any petition filed under section 2111 the Secretary shall publish notice of such petition in the Federal Register.’’ Set forth below is a list of petitions received by HRSA on May 1, 2021, through May 31, 2021. This list provides the name of petitioner, city and state of vaccination (if unknown then city and state of person or attorney filing claim), and case number. In cases where the Court has redacted the name of a petitioner and/or the case number, the list reflects such redaction. Section 2112(b)(2) also provides that the special master ‘‘shall afford all SUPPLEMENTARY INFORMATION: PO 00000 Frm 00110 Fmt 4703 Sfmt 4703 33315 interested persons an opportunity to submit relevant, written information’’ relating to the following: 1. The existence of evidence ‘‘that there is not a preponderance of the evidence that the illness, disability, injury, condition, or death described in the petition is due to factors unrelated to the administration of the vaccine described in the petition,’’ and 2. Any allegation in a petition that the petitioner either: a. ‘‘[S]ustained, or had significantly aggravated, any illness, disability, injury, or condition not set forth in the Vaccine Injury Table but which was caused by’’ one of the vaccines referred to in the Table, or b. ‘‘[S]ustained, or had significantly aggravated, any illness, disability, injury, or condition set forth in the Vaccine Injury Table the first symptom or manifestation of the onset or significant aggravation of which did not occur within the time period set forth in the Table but which was caused by a vaccine’’ referred to in the Table. In accordance with Section 2112(b)(2), all interested persons may submit written information relevant to the issues described above in the case of the petitions listed below. Any person choosing to do so should file an original and three (3) copies of the information with the Clerk of the United States Court of Federal Claims at the address listed above (under the heading ‘‘For Further Information Contact’’), with a copy to HRSA addressed to Director, Division of Injury Compensation Programs, Healthcare Systems Bureau, 5600 Fishers Lane, 08N146B, Rockville, Maryland 20857. The Court’s caption (Petitioner’s Name v. Secretary of HHS) and the docket number assigned to the petition should be used as the caption for the written submission. Chapter 35 of title 44, United States Code, related to paperwork reduction, does not apply to information required for purposes of carrying out the Program. Diana Espinosa, Acting Administrator. List of Petitions Filed 1. Kelly Hannon, Washington, District of Columbia, Court of Federal Claims No: 21–1304V 2. Margaret Hoyt, Washington, District of Columbia, Court of Federal Claims No: 21–1305V 3. Sarah Lopez, Washington, District of Columbia, Court of Federal Claims No: 21–1306V 4. Lydia M. Goode, Greensboro, North Carolina, Court of Federal Claims No: 21–1307V 5. Jonathan Jarog, Chicago, Illinois, Court of Federal Claims No: 21–1308V E:\FR\FM\24JNN1.SGM 24JNN1

Agencies

[Federal Register Volume 86, Number 119 (Thursday, June 24, 2021)]
[Notices]
[Pages 33313-33315]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-13388]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-1553]


Premenopausal Women With Breast Cancer: Developing Drugs for 
Treatment; 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 
``Premenopausal Women with Breast Cancer: Developing Drugs for 
Treatment.'' This guidance provides recommendations regarding the 
inclusion of premenopausal women in breast cancer clinical trials. The 
guidance is intended to assist stakeholders, including sponsors and 
institutional review boards, responsible for the development and 
oversight of clinical trials for breast cancer drugs. This guidance 
finalizes the draft guidance of the same title issued on October 8, 
2020.

DATES: The announcement of the guidance is published in the Federal 
Register on June 24, 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

[[Page 33314]]

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-2020-D-1553 for ``Premenopausal Women with Breast Cancer: 
Developing Drugs for Treatment.'' 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 submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the 
Division of Drug Information, Center for Drug Evaluation and Research 
(CDER), Food and Drug Administration, 10001 New Hampshire Ave., 
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002 or Office 
of Communication, Outreach and Development, Center for Biologics 
Evaluation and Research (CBER), Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send 
one self-addressed adhesive label to assist that office in processing 
your requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Jennifer Gao, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 2135, Silver Spring, MD 20993, 240-402-
4683; or Julia Beaver, Center for Drug Evaluation and Research, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 2100, 
Silver Spring, MD 20993, 240-402-0489; or Stephen Ripley, Center for 
Biologics Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240-
402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Premenopausal Women with Breast Cancer: Developing Drugs for 
Treatment.'' This guidance provides recommendations regarding the 
inclusion of premenopausal women, as defined by serum hormonal levels 
(including but not limited to follicle-stimulating hormone and 
estradiol), in breast cancer clinical trials. The issues of fertility 
and fertility preservation when treating premenopausal women with 
breast cancer are outside the scope of this guidance.
    Historically, premenopausal women have been excluded from some 
trials that have investigated the efficacy of certain drugs that rely 
upon manipulation of the hormonal axis for the treatment of hormone 
receptor (HR) positive breast cancer. In some cases, separate studies 
have been conducted to confirm the benefit in this patient population. 
Certain groups of drugs, such as chemotherapy, immunotherapy, and 
targeted therapy (which act independent of the hormonal axis), have 
similar efficacy in pre- and postmenopausal women with breast cancer. 
Based on a review of the literature, FDA believes hormonal drugs 
administered to premenopausal women with HR-positive breast cancer, 
with adequate estrogen suppression, are likely to have the same 
efficacy and safety profile as in postmenopausal women.
    The guidance encourages sponsors to discuss their breast cancer 
drug development plan with CDER and CBER, as applicable, early in 
development. The guidance recommends that menopausal status should not 
be the basis for exclusion from breast cancer clinical trials. The 
guidance includes recommendations regarding eligibility criteria and 
study planning and design intended to facilitate the inclusion of 
premenopausal women in breast cancer clinical trials.
    This guidance finalizes the draft guidance entitled ``Premenopausal 
Women with Breast Cancer: Developing Drugs for Treatment'' issued on 
October 8, 2020 (85 FR 63559). FDA considered comments received on the 
draft guidance as the guidance was finalized. Changes from the draft to 
the final guidance include additional recommendations on the importance 
of clinical studies reflecting racial and ethnic diversity and to 
collect patient experience data throughout the development program. 
Other changes include updated recommendations on collection of clinical 
effects as part of the clinical development program or as part of a 
postmarketing requirement or commitment as applicable.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on ``Premenopausal Women with Breast Cancer: 
Developing Drugs for Treatment.'' It does not establish any rights for 
any person and is not binding on FDA or the public. You can use an 
alternative approach if it satisfies the requirements of the applicable 
statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does 
refer to previously approved FDA collections of

[[Page 33315]]

information. Therefore, clearance by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 
3501-3521) is not required for this guidance. The previously approved 
collections of information are subject to review by OMB under the PRA. 
The collections of information in 21 CFR part 312 have been approved 
under OMB control number 0910-0014; the collections of information in 
21 CFR part 314 have been approved under OMB control number 0910-0001; 
and the collections of information in 21 CFR part 601 have been 
approved under 0910-0338.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: June 15, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-13388 Filed 6-23-21; 8:45 am]
BILLING CODE 4164-01-P
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