83 FR 383 - Establishing Effectiveness for Drugs Intended To Treat Male Hypogonadotropic Hypogonadism Attributed to Non-Structural Disorders; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 2 (January 3, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 2 (January 3, 2018)
| Page Range | 383-384 | |
| FR Document | 2017-28337 |
[Federal Register Volume 83, Number 2 (Wednesday, January 3, 2018)] [Notices] [Pages 383-384] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-28337] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-D-6759] Establishing Effectiveness for Drugs Intended To Treat Male Hypogonadotropic Hypogonadism Attributed to Non-Structural Disorders; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Establishing Effectiveness for Drugs Intended to Treat Male Hypogonadotropic Hypogonadism Attributed to Non-Structural Disorders.'' This draft guidance provides key design considerations, including recommendations for patient enrollment criteria and efficacy endpoints, for clinical trials to establish effectiveness for drugs intended to treat male hypogonadotropic hypogonadism associated with obesity and other conditions that do not cause intrinsic damage to the hypothalamus or pituitary gland. This draft guidance is consistent with recommendations FDA received at the December 2014 advisory committee meeting on the appropriate indicated population for testosterone replacement therapy, and the December 2016 advisory committee meeting on hypogonadotropic hypogonadism. DATES: Submit either electronic or written comments on the draft guidance by March 5, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance 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 [[Page 384]] identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2017-D-6759 for ``Establishing Effectiveness for Drugs Intended to Treat Male Hypogonadotropic Hypogonadism Attributed to Non-Structural Disorders.'' 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 office between 9 a.m. and 4 p.m., Monday through Friday. 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.thefederalregister.org/fdsys/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. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, 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 draft guidance document. FOR FURTHER INFORMATION CONTACT: Jeannie Roule, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 5332, Silver Spring, MD 20993-0002, 301- 796-3993. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ``Establishing Effectiveness for Drugs Intended to Treat Male Hypogonadotropic Hypogonadism Attributed to Non-Structural Disorders.'' This draft guidance is intended to assist sponsors in designing drug development programs to demonstrate effectiveness of drugs intended to treat male hypogonadotropic hypogonadism associated with obesity and other conditions that do not cause intrinsic damage to the hypothalamus or pituitary gland. Male hypogonadism is characterized by serum testosterone concentrations below the lower limit of the normal range for young, healthy men with associated symptoms (e.g., reduced libido) or signs (e.g., loss of muscle mass with reduced muscle strength). Some men who have had normal puberty and sexual development are subsequently diagnosed with hypogonadotropic hypogonadism associated with obesity or other acquired conditions in the absence of intrinsic damage to the hypothalamus or pituitary. Although these men have serum testosterone concentrations below the lower limit of the normal range for young, healthy men, the associated symptoms often experienced in this population (e.g., low energy, depressed mood) are nonspecific and cannot definitively be attributed to the low testosterone concentrations. In addition, it is unclear whether these testosterone concentrations--in the absence of intrinsic damage to the hypothalamus and pituitary gland--are inappropriately low and whether increasing testosterone concentrations in these men confers clinical benefit. For these reasons, serum testosterone is not a validated surrogate endpoint for establishing efficacy in these patients, and sponsors would need to show that an increase in serum testosterone translates into improvement in how patients feel, function, or survive. This draft guidance addresses the following topics in establishing effectiveness of drugs for this population: Identification of patients for inclusion in clinical trials and Efficacy endpoints. This draft guidance is consistent with recommendations FDA received at the December 2014 advisory committee meeting on the appropriate indicated population for testosterone replacement therapy, and the December 2016 advisory committee meeting on hypogonadotropic hypogonadism. This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on establishing effectiveness for drugs intended to treat male hypogonadotropic hypogonadism attributed to non-structural disorders. 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. This guidance is not subject to Executive Order 12866. II. Electronic Access Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or https://www.regulations.gov. Dated: December 27, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-28337 Filed 1-2-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 2 / Wednesday, January 3, 2018 / Notices 383
The study team will also collect Respondents: Early care and center-based and family child care
classroom rosters from caregivers before education (ECE) setting representatives settings), and professional development
and after the field test. (e.g., directors or owners), caregivers (in providers (e.g., coaches).
ANNUAL BURDEN ESTIMATES
Total/annual Number of Average Annual burden
Instrument number of responses per burden hours hours
respondents respondent per response
ECE setting eligibility screener ........................................................................ 745 1 .25 186
Caregiver background survey .......................................................................... 300 1 .75 225
PD provider background survey ...................................................................... 175 1 .50 88
Caregiver We Grow Together website user data pop-up questions ............... 300 6 .17 306
PD provider We Grow Together website user pop-up questions ................... 175 5 .10 88
Caregiver feedback survey .............................................................................. 300 1 1.0 300
PD provider feedback survey .......................................................................... 175 1 .75 131
Classroom roster ............................................................................................. 300 2 .08 48
PD provider training survey ............................................................................. 175 1 .17 30
Estimated Total Annual Burden DEPARTMENT OF HEALTH AND ADDRESSES: You may submit comments
Hours: 1,402. HUMAN SERVICES on any guidance at any time as follows:
In compliance with the requirements Electronic Submissions
Food and Drug Administration
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the [Docket No. FDA–2017–D–6759] Submit electronic comments in the
Administration for Children and following way:
Families is soliciting public comment Establishing Effectiveness for Drugs • Federal eRulemaking Portal:
on the specific aspects of the Intended To Treat Male https://www.regulations.gov. Follow the
Hypogonadotropic Hypogonadism instructions for submitting comments.
information collection described above.
Attributed to Non-Structural Disorders; Comments submitted electronically,
Copies of the proposed collection of
Draft Guidance for Industry; including attachments, to https://
information can be obtained and
Availability www.regulations.gov will be posted to
comments may be forwarded by writing
the docket unchanged. Because your
to the Administration for Children and AGENCY: Food and Drug Administration,
comment will be made public, you are
Families, Office of Planning, Research, HHS.
solely responsible for ensuring that your
and Evaluation, 330 C Street SW, ACTION: Notice of availability. comment does not include any
Washington, DC 20201, Attn: OPRE confidential information that you or a
Reports Clearance Officer. Email SUMMARY: The Food and Drug
Administration (FDA or Agency) is third party may not wish to be posted,
address: OPREinfocollection@ such as medical information, your or
announcing the availability of a draft
acf.hhs.gov. All requests should be anyone else’s Social Security number, or
guidance for industry entitled
identified by the title of the information confidential business information, such
‘‘Establishing Effectiveness for Drugs
collection. Intended to Treat Male as a manufacturing process. Please note
The Department specifically requests Hypogonadotropic Hypogonadism that if you include your name, contact
comments on (a) whether the proposed Attributed to Non-Structural Disorders.’’ information, or other information that
collection of information is necessary This draft guidance provides key design identifies you in the body of your
for the proper performance of the considerations, including comments, that information will be
functions of the agency, including recommendations for patient enrollment posted on https://www.regulations.gov.
whether the information shall have criteria and efficacy endpoints, for • If you want to submit a comment
practical utility; (b) the accuracy of the clinical trials to establish effectiveness with confidential information that you
agency’s estimate of the burden of the for drugs intended to treat male do not wish to be made available to the
proposed collection of information; (c) hypogonadotropic hypogonadism public, submit the comment as a
the quality, utility, and clarity of the associated with obesity and other written/paper submission and in the
conditions that do not cause intrinsic manner detailed (see ‘‘Written/Paper
information to be collected; and (d)
damage to the hypothalamus or Submissions’’ and ‘‘Instructions’’).
ways to minimize the burden of the
collection of information on pituitary gland. This draft guidance is Written/Paper Submissions
respondents, including through the use consistent with recommendations FDA
received at the December 2014 advisory Submit written/paper submissions as
of automated collection techniques or follows:
committee meeting on the appropriate
other forms of information technology.
indicated population for testosterone • Mail/Hand delivery/Courier (for
Consideration will be given to
replacement therapy, and the December written/paper submissions): Dockets
comments and suggestions submitted 2016 advisory committee meeting on Management Staff (HFA–305), Food and
sradovich on DSK3GMQ082PROD with NOTICES
within 60 days of this publication. hypogonadotropic hypogonadism. Drug Administration, 5630 Fishers
Mary Jones, DATES: Submit either electronic or Lane, Rm. 1061, Rockville, MD 20852.
ACF/OPRE Certifying Officer. written comments on the draft guidance • For written/paper comments
[FR Doc. 2017–28375 Filed 1–2–18; 8:45 am] by March 5, 2018 to ensure that the submitted to the Dockets Management
Agency considers your comment on this Staff, FDA will post your comment, as
BILLING CODE 4184–22–P
draft guidance before it begins work on well as any attachments, except for
the final version of the guidance. information submitted, marked and
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![384 Federal Register / Vol. 83, No. 2 / Wednesday, January 3, 2018 / Notices
identified, as confidential, if submitted Drug Evaluation and Research, Food an increase in serum testosterone
as detailed in ‘‘Instructions.’’ and Drug Administration, 10001 New translates into improvement in how
Instructions: All submissions received Hampshire Ave., Hillandale Building, patients feel, function, or survive.
must include the Docket No. FDA– 4th Floor, Silver Spring, MD 20993– This draft guidance addresses the
2017–D–6759 for ‘‘Establishing 0002. Send one self-addressed adhesive following topics in establishing
Effectiveness for Drugs Intended to label to assist that office in processing effectiveness of drugs for this
Treat Male Hypogonadotropic your requests. See the SUPPLEMENTARY population:
Hypogonadism Attributed to Non- INFORMATION section for electronic • Identification of patients for inclusion
Structural Disorders.’’ Received access to the draft guidance document. in clinical trials and
comments will be placed in the docket FOR FURTHER INFORMATION CONTACT: • Efficacy endpoints.
and, except for those submitted as Jeannie Roule, Center for Drug This draft guidance is consistent with
‘‘Confidential Submissions,’’ publicly Evaluation and Research, Food and recommendations FDA received at the
viewable at https://www.regulations.gov Drug Administration, 10903 New December 2014 advisory committee
or at the Dockets Management Staff Hampshire Ave., Bldg. 22, Rm. 5332, meeting on the appropriate indicated
office between 9 a.m. and 4 p.m., Silver Spring, MD 20993–0002, 301– population for testosterone replacement
Monday through Friday. 796–3993. therapy, and the December 2016
• Confidential Submissions—To advisory committee meeting on
submit a comment with confidential SUPPLEMENTARY INFORMATION:
hypogonadotropic hypogonadism.
information that you do not wish to be I. Background This draft guidance is being issued
made publicly available, submit your consistent with FDA’s good guidance
comments only as a written/paper FDA is announcing the availability of
a draft guidance for industry entitled practices regulation (21 CFR 10.115).
submission. You should submit two The draft guidance, when finalized, will
copies total. One copy will include the ‘‘Establishing Effectiveness for Drugs
Intended to Treat Male represent the current thinking of FDA
information you claim to be confidential on establishing effectiveness for drugs
with a heading or cover note that states Hypogonadotropic Hypogonadism
Attributed to Non-Structural Disorders.’’ intended to treat male
‘‘THIS DOCUMENT CONTAINS hypogonadotropic hypogonadism
CONFIDENTIAL INFORMATION.’’ The This draft guidance is intended to assist
sponsors in designing drug development attributed to non-structural disorders. It
Agency will review this copy, including does not establish any rights for any
the claimed confidential information, in programs to demonstrate effectiveness
of drugs intended to treat male person and is not binding on FDA or the
its consideration of comments. The public. You can use an alternative
second copy, which will have the hypogonadotropic hypogonadism
associated with obesity and other approach if it satisfies the requirements
claimed confidential information of the applicable statutes and
redacted/blacked out, will be available conditions that do not cause intrinsic
damage to the hypothalamus or regulations. This guidance is not subject
for public viewing and posted on
pituitary gland. to Executive Order 12866.
https://www.regulations.gov. Submit
both copies to the Dockets Management Male hypogonadism is characterized II. Electronic Access
Staff. If you do not wish your name and by serum testosterone concentrations
below the lower limit of the normal Persons with access to the internet
contact information to be made publicly may obtain the draft guidance at either
available, you can provide this range for young, healthy men with
associated symptoms (e.g., reduced https://www.fda.gov/Drugs/Guidance
information on the cover sheet and not ComplianceRegulatoryInformation/
in the body of your comments and you libido) or signs (e.g., loss of muscle mass
with reduced muscle strength). Some Guidances/default.htm, or https://
must identify this information as www.regulations.gov.
‘‘confidential.’’ Any information marked men who have had normal puberty and
as ‘‘confidential’’ will not be disclosed sexual development are subsequently Dated: December 27, 2017.
except in accordance with 21 CFR 10.20 diagnosed with hypogonadotropic Leslie Kux,
and other applicable disclosure law. For hypogonadism associated with obesity Associate Commissioner for Policy.
more information about FDA’s posting or other acquired conditions in the [FR Doc. 2017–28337 Filed 1–2–18; 8:45 am]
of comments to public dockets, see 80 absence of intrinsic damage to the BILLING CODE 4164–01–P
FR 56469, September 18, 2015, or access hypothalamus or pituitary. Although
the information at: https://www.gpo.gov/ these men have serum testosterone
fdsys/pkg/FR-2015-09-18/pdf/2015- concentrations below the lower limit of DEPARTMENT OF HEALTH AND
23389.pdf. the normal range for young, healthy HUMAN SERVICES
Docket: For access to the docket to men, the associated symptoms often
read background documents or the experienced in this population (e.g., low Office of the Secretary
electronic and written/paper comments energy, depressed mood) are
received, go to https:// nonspecific and cannot definitively be Findings of Research Misconduct;
www.regulations.gov and insert the attributed to the low testosterone Correction
docket number, found in brackets in the concentrations. In addition, it is unclear AGENCY: Office of the Secretary, HHS.
heading of this document, into the whether these testosterone ACTION: Correction of notice.
‘‘Search’’ box and follow the prompts concentrations—in the absence of
and/or go to the Dockets Management intrinsic damage to the hypothalamus SUMMARY: This document corrects an
and pituitary gland—are inappropriately
sradovich on DSK3GMQ082PROD with NOTICES
Staff, 5630 Fishers Lane, Rm. 1061, error that appeared in the notice
Rockville, MD 20852. low and whether increasing testosterone published in the November 27, 2017,
You may submit comments on any concentrations in these men confers Federal Register entitled ‘‘Findings of
guidance at any time (see 21 CFR clinical benefit. Research Misconduct.’’
10.115(g)(5)). For these reasons, serum testosterone DATES:
Submit written requests for single is not a validated surrogate endpoint for Effective Date: January 3, 2018.
copies of the draft guidance to the establishing efficacy in these patients, Applicability Date: The correction
Division of Drug Information, Center for and sponsors would need to show that notice is applicable for the Findings of
VerDate Sep<11>2014 16:13 Jan 02, 2018 Jkt 244001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 E:\FR\FM\03JAN1.SGM 03JAN1](https://thefederalregister.org/doc/83_FR_385/page/2.svg)
Document Created: 2018-10-26 09:29:57
Document Modified: 2018-10-26 09:29:57
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| Dates | Submit either electronic or written comments on the draft guidance by March 5, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. | |
| Contact | Jeannie Roule, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 5332, Silver Spring, MD 20993-0002, 301- 796-3993. | |
| FR Citation | 83 FR 383 |
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