81_FR_11855 81 FR 11811 - Environmental Assessment: Questions and Answers Regarding Drugs With Estrogenic, Androgenic, or Thyroid Activity; Guidance for Industry; Availability

81 FR 11811 - Environmental Assessment: Questions and Answers Regarding Drugs With Estrogenic, Androgenic, or Thyroid Activity; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 44 (March 7, 2016)

Page Range11811-11812
FR Document2016-04964

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Environmental Assessment: Questions and Answers Regarding Drugs With Estrogenic, Androgenic, or Thyroid Activity.'' It is intended to help sponsors of such drugs determine whether they should submit environmental assessments (EA) for drug applications and certain supplements, and to clarify what information such sponsors should include if they submit a claim of categorical exclusion instead of an EA.

Federal Register, Volume 81 Issue 44 (Monday, March 7, 2016) 
[Federal Register Volume 81, Number 44 (Monday, March 7, 2016)]
[Notices]
[Pages 11811-11812]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-04964]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-1213]


Environmental Assessment: Questions and Answers Regarding Drugs 
With Estrogenic, Androgenic, or Thyroid Activity; Guidance for 
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a guidance for industry entitled ``Environmental 
Assessment: Questions and Answers Regarding Drugs With Estrogenic, 
Androgenic, or Thyroid Activity.'' It is intended to help sponsors of 
such drugs determine whether they should submit environmental 
assessments (EA) for drug applications and certain supplements, and to 
clarify what information such sponsors should include if they submit a 
claim of categorical exclusion instead of an EA.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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-2015-D-1213 for Environmental Assessment: Questions and Answers 
Regarding Drugs with Estrogenic, Androgenic, or Thyroid Activity. 
Received comments will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management 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

[[Page 11812]]

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 http://www.regulations.gov. Submit both copies to the 
Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of this 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 guidance document.

FOR FURTHER INFORMATION CONTACT: Raanan A. Bloom, Environmental 
Assessment Team, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 
301-796-2185, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Environmental Assessment: Questions and Answers Regarding 
Drugs with Estrogenic, Androgenic, or Thyroid Activity.'' This guidance 
finalizes the draft of the same name that published on April 29, 2015. 
The National Environmental Policy Act of 1969 (NEPA) requires all 
Federal agencies to assess the environmental impact of their actions 
and to ensure that the interested and affected public is informed of 
the environmental analyses. FDA regulations at 21 CFR part 25 specify 
that EAs must be submitted as part of certain new drug applications 
(NDAs), abbreviated new drug applications (ANDAs), biologic license 
applications (BLAs), supplements to such applications, and 
investigational new drug applications (INDs), and for various other 
actions, unless the action qualifies for a categorical exclusion. 
Failure to submit either an EA or a claim of categorical exclusion is 
sufficient grounds for FDA to refuse to file or approve an application 
(21 CFR 25.15(a), 314.101(d)(4) and 601.2(a) and (c)).
    Categorical exclusions for actions related to human drugs and 
biologics are listed at 21 CFR 25.31. This guidance focuses on the 
categorical exclusion for actions on NDAs and NDA supplements that 
would increase the use of an active moiety, but the estimated 
concentration of the substance at the point of entry into the aquatic 
environment would be below 1 part per billion (1 ppb) (21 CFR 
25.31(b)). Although an action that qualifies for this exclusion 
ordinarily does not require an EA, FDA will require ``at least an EA'' 
if ``extraordinary circumstances'' indicate that the specific proposed 
action (e.g., the approval of the NDA) may significantly affect the 
quality of the human environment (21 CFR 25.21). Research indicates 
that drugs with endocrine-related activity and, more specifically, 
drugs with Estrogenic, Androgenic, or Thyroid Activity (E, A, or T) 
activity have the potential to cause developmental or reproductive 
effects when present in the aquatic environment at concentrations below 
1 ppb.\1\
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    \1\ For example, see Section II.C (pp. 7-13) of USFDA, 2013, 
``Response to Citizen Petition to the FDA Commissioner under the 
National Environmental Policy Act and Administrative Procedure Act 
Requesting an Amendment to an FDA Rule Regarding Human Drugs and 
Biologics,'' Docket No. FDA-2010-P-0377; U.S. Environmental 
Protection Agency (USEPA), Endocrine Disruptor Screening Program 
(EDSP), last accessed February 17, 2015, at http://www.epa.gov/endo; 
and Organisation for Economic Co-operation and Development (OECD), 
OECD Work Related to Endocrine Disrupters, last accessed February 
17, 2015, at http://www.oecd.org/env/ehs/testing/oecdworkrelatedtoendocrinedisrupters.htm.
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    FDA has, on a case-by-case basis, requested additional information 
from sponsors of NDAs and NDA supplements for drugs with E, A, or T 
activity to help it determine whether extraordinary circumstances 
exist. However, late cycle requests for additional environmental 
information have the potential to delay approval of applications. 
Accordingly, this guidance is intended to clarify that sponsors of 
drugs with potential E, A, or T activity should consult with the Agency 
early in product development concerning the information FDA may need to 
determine whether an EA will be required or whether a claim of 
categorical exclusion will be acceptable, and what information should 
be included in the EA or claim of categorical exclusion.
    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 Environmental Assessment: Questions and 
Answers Regarding Drugs With Estrogenic, Androgenic, or Thyroid 
Activity. 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. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information that are subject to review by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in 21 CFR part 25 have been 
approved under OMB control number 0910-0322 and the collections of 
information in 21 CFR part 314 have been approved under OMB control 
number 0910-0001.

III. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: March 1, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-04964 Filed 3-4-16; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 44 / Monday, March 7, 2016 / Notices 11811 entitled ‘‘Medical Devices and Clinical 0910–0078; the collections of ADDRESSES: You may submit comments Trial Design for the Treatment or information in 21 CFR part 814, as follows: Improvement in the Appearance of subparts B and E are approved under Electronic Submissions Fungally-Infected Nails.’’ This guidance OMB control number 0910–0231; the is intended to provide recommendations collections of information in 21 CFR Submit electronic comments in the regarding clinical trial design for part 814, subpart H are approved under following way: medical devices intended either (1) to OMB control number 0910–0332; the • Federal eRulemaking Portal: http:// provide improvement in the appearance collections of information regarding www.regulations.gov. Follow the of nails affected by onychomycosis, or adverse events have been approved instructions for submitting comments. (2) to treat onychomycosis (fungal nail under OMB control number 0910–0471; Comments submitted electronically, infection). and the collections of information in 21 including attachments, to http:// In the Federal Register on January 27, CFR part 801 have been approved under www.regulations.gov will be posted to 2015 (80 FR 4281), FDA announced the OMB control number 0910–0485. the docket unchanged. Because your availability of the draft guidance The labeling recommendations of this comment will be made public, you are document. Interested persons were guidance are not subject to review by solely responsible for ensuring that your invited to comment by April 27, 2015. the Office of Management and Budget comment does not include any because they do not constitute a confidential information that you or a II. Significance of Guidance ‘‘collection of information’’ under the third party may not wish to be posted, This guidance is being issued Paperwork Reduction Act of 1995 (44 such as medical information, your or consistent with FDA’s good guidance U.S.C. 3501–3520). Rather, the anyone else’s Social Security number, or practices regulation (21 CFR 10.115). recommended labeling is a ‘‘public confidential business information, such The guidance represents the current disclosure of information originally as a manufacturing process. Please note thinking of FDA on medical devices and supplied by the Federal Government to that if you include your name, contact clinical trial design for the treatment or the recipient for the purpose of information, or other information that improvement in the appearance of disclosure to the public’’ (see 5 CFR identifies you in the body of your fungally-infected nails. It does not 1320.3(c)(2)). comments, that information will be establish any rights for any person and posted on http://www.regulations.gov. is not binding on FDA or the public. Dated: March 1, 2016. • If you want to submit a comment You can use an alternative approach if Leslie Kux, with confidential information that you it satisfies the requirements of the Associate Commissioner for Policy. do not wish to be made available to the applicable statutes and regulations. [FR Doc. 2016–04946 Filed 3–4–16; 8:45 am] public, submit the comment as a III. Electronic Access BILLING CODE 4164–01–P written/paper submission and in the manner detailed (see ‘‘Written/Paper Persons interested in obtaining a copy Submissions’’ and ‘‘Instructions’’). of the guidance may do so by DEPARTMENT OF HEALTH AND downloading an electronic copy from HUMAN SERVICES Written/Paper Submissions the Internet. A search capability for all Submit written/paper submissions as Center for Devices and Radiological Food and Drug Administration follows: Health guidance documents is available [Docket No. FDA–2015–D–1213] • Mail/Hand delivery/Courier (for at http://www.fda.gov/MedicalDevices/ written/paper submissions): Division of DeviceRegulationandGuidance/ Environmental Assessment: Questions Dockets Management (HFA–305), Food GuidanceDocuments/default.htm. and Answers Regarding Drugs With and Drug Administration, 5630 Fishers Guidance documents are also available Estrogenic, Androgenic, or Thyroid Lane, Rm. 1061, Rockville, MD 20852. at http://www.regulations.gov. Persons Activity; Guidance for Industry; • For written/paper comments unable to download an electronic copy Availability submitted to the Division of Dockets of ‘‘Medical Devices and Clinical Trial Management, FDA will post your Design for the Treatment or AGENCY: Food and Drug Administration, comment, as well as any attachments, Improvement in the Appearance of HHS. except for information submitted, Fungally-Infected Nails’’ may send an ACTION: Notice of availability. marked and identified, as confidential, email request to CDRH-Guidance@ if submitted as detailed in fda.hhs.gov to receive an electronic SUMMARY: The Food and Drug ‘‘Instructions.’’ copy of the document. Please use the Administration (FDA or Agency) is Instructions: All submissions received document number 1400009 to identify announcing the availability of a must include the Docket No. FDA– the guidance you are requesting. guidance for industry entitled 2015–D–1213 for Environmental ‘‘Environmental Assessment: Questions Assessment: Questions and Answers IV. Paperwork Reduction Act of 1995 and Answers Regarding Drugs With Regarding Drugs with Estrogenic, This guidance refers to previously Estrogenic, Androgenic, or Thyroid Androgenic, or Thyroid Activity. approved collections of information Activity.’’ It is intended to help Received comments will be placed in found in FDA regulations. These sponsors of such drugs determine the docket and, except for those collections of information are subject to whether they should submit submitted as ‘‘Confidential review by the Office of Management and environmental assessments (EA) for Submissions,’’ publicly viewable at asabaliauskas on DSK3SPTVN1PROD with NOTICES Budget (OMB) under the Paperwork drug applications and certain http://www.regulations.gov or at the Reduction Act of 1995 (44 U.S.C. 3501– supplements, and to clarify what Division of Dockets Management 3520). The collections of information in information such sponsors should between 9 a.m. and 4 p.m., Monday 21 CFR part 807, subpart E have been include if they submit a claim of through Friday. approved under OMB control number categorical exclusion instead of an EA. • Confidential Submissions—To 0910–0120; the collections of DATES: Submit either electronic or submit a comment with confidential information in 21 CFR part 812 are written comments on Agency guidances information that you do not wish to be approved under OMB control number at any time. made publicly available, submit your VerDate Sep<11>2014 18:37 Mar 04, 2016 Jkt 238001 PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 E:\FR\FM\07MRN1.SGM 07MRN1

11812 Federal Register / Vol. 81, No. 44 / Monday, March 7, 2016 / Notices comments only as a written/paper I. Background FDA has, on a case-by-case basis, submission. You should submit two FDA is announcing the availability of requested additional information from copies total. One copy will include the a guidance for industry entitled sponsors of NDAs and NDA information you claim to be confidential ‘‘Environmental Assessment: Questions supplements for drugs with E, A, or T with a heading or cover note that states and Answers Regarding Drugs with activity to help it determine whether ‘‘THIS DOCUMENT CONTAINS Estrogenic, Androgenic, or Thyroid extraordinary circumstances exist. CONFIDENTIAL INFORMATION.’’ The Activity.’’ This guidance finalizes the However, late cycle requests for Agency will review this copy, including draft of the same name that published additional environmental information the claimed confidential information, in on April 29, 2015. The National have the potential to delay approval of its consideration of comments. The Environmental Policy Act of 1969 applications. Accordingly, this guidance second copy, which will have the (NEPA) requires all Federal agencies to is intended to clarify that sponsors of claimed confidential information assess the environmental impact of their drugs with potential E, A, or T activity redacted/blacked out, will be available actions and to ensure that the interested should consult with the Agency early in for public viewing and posted on and affected public is informed of the product development concerning the http://www.regulations.gov. Submit environmental analyses. FDA information FDA may need to determine both copies to the Division of Dockets regulations at 21 CFR part 25 specify whether an EA will be required or that EAs must be submitted as part of whether a claim of categorical exclusion Management. If you do not wish your certain new drug applications (NDAs), will be acceptable, and what name and contact information to be abbreviated new drug applications information should be included in the made publicly available, you can (ANDAs), biologic license applications EA or claim of categorical exclusion. provide this information on the cover (BLAs), supplements to such This guidance is being issued sheet and not in the body of your applications, and investigational new consistent with FDA’s good guidance comments and you must identify this drug applications (INDs), and for practices regulation (21 CFR 10.115). information as ‘‘confidential.’’ Any various other actions, unless the action The guidance represents the current information marked as ‘‘confidential’’ qualifies for a categorical exclusion. thinking of FDA on Environmental will not be disclosed except in Failure to submit either an EA or a Assessment: Questions and Answers accordance with 21 CFR 10.20 and other claim of categorical exclusion is Regarding Drugs With Estrogenic, applicable disclosure law. For more sufficient grounds for FDA to refuse to Androgenic, or Thyroid Activity. It does information about FDA’s posting of file or approve an application (21 CFR not establish any rights for any person comments to public dockets, see 80 FR 25.15(a), 314.101(d)(4) and 601.2(a) and and is not binding on FDA or the public. 56469, September 18, 2015, or access (c)). You can use an alternative approach if the information at: http://www.fda.gov/ Categorical exclusions for actions it satisfies the requirements of the regulatoryinformation/dockets/ related to human drugs and biologics applicable statutes and regulations. default.htm. are listed at 21 CFR 25.31. This guidance focuses on the categorical II. The Paperwork Reduction Act of Docket: For access to the docket to 1995 read background documents or the exclusion for actions on NDAs and NDA electronic and written/paper comments supplements that would increase the This guidance refers to previously received, go to http:// use of an active moiety, but the approved collections of information that estimated concentration of the are subject to review by the Office of www.regulations.gov and insert the substance at the point of entry into the Management and Budget (OMB) under docket number, found in brackets in the aquatic environment would be below 1 the Paperwork Reduction Act of 1995 heading of this document, into the part per billion (1 ppb) (21 CFR (44 U.S.C. 3501–3520). The collections ‘‘Search’’ box and follow the prompts 25.31(b)). Although an action that of information in 21 CFR part 25 have and/or go to the Division of Dockets qualifies for this exclusion ordinarily been approved under OMB control Management, 5630 Fishers Lane, Rm. does not require an EA, FDA will 1061, Rockville, MD 20852. number 0910–0322 and the collections require ‘‘at least an EA’’ if of information in 21 CFR part 314 have Submit written requests for single ‘‘extraordinary circumstances’’ indicate been approved under OMB control copies of this guidance to the Division that the specific proposed action (e.g., number 0910–0001. of Drug Information, Center for Drug the approval of the NDA) may Evaluation and Research, Food and significantly affect the quality of the III. Electronic Access Drug Administration, 10001 New human environment (21 CFR 25.21). Persons with access to the Internet Hampshire Ave., Hillandale Building, Research indicates that drugs with may obtain the guidance at either 4th Floor, Silver Spring, MD 20993– endocrine-related activity and, more http://www.fda.gov/Drugs/ 0002. Send one self-addressed adhesive specifically, drugs with Estrogenic, GuidanceComplianceRegulatory label to assist that office in processing Androgenic, or Thyroid Activity (E, A, Information/Guidances/default.htm or your requests. See the SUPPLEMENTARY or T) activity have the potential to cause http://www.regulations.gov. INFORMATION section for electronic developmental or reproductive effects access to the guidance document. when present in the aquatic Dated: March 1, 2016. environment at concentrations below 1 Leslie Kux, FOR FURTHER INFORMATION CONTACT: ppb.1 Associate Commissioner for Policy. asabaliauskas on DSK3SPTVN1PROD with NOTICES Raanan A. Bloom, Environmental [FR Doc. 2016–04964 Filed 3–4–16; 8:45 am] Assessment Team, Center for Drug 1 For example, see Section II.C (pp. 7–13) of BILLING CODE 4164–01–P Evaluation and Research, Food and USFDA, 2013, ‘‘Response to Citizen Petition to the Drug Administration, 10903 New FDA Commissioner under the National Environmental Policy Act and Administrative 17, 2015, at http://www.epa.gov/endo; and Hampshire Ave., Silver Spring, MD Procedure Act Requesting an Amendment to an Organisation for Economic Co-operation and 20993–0002, 301–796–2185, FDA Rule Regarding Human Drugs and Biologics,’’ Development (OECD), OECD Work Related to CDER.EA.Team@fda.hhs.gov. Docket No. FDA–2010–P–0377; U.S. Environmental Endocrine Disrupters, last accessed February 17, Protection Agency (USEPA), Endocrine Disruptor 2015, at http://www.oecd.org/env/ehs/testing/ SUPPLEMENTARY INFORMATION: Screening Program (EDSP), last accessed February oecdworkrelatedtoendocrinedisrupters.htm. VerDate Sep<11>2014 18:37 Mar 04, 2016 Jkt 238001 PO 00000 Frm 00075 Fmt 4703 Sfmt 9990 E:\FR\FM\07MRN1.SGM 07MRN1


Document Created: 2018-02-02 15:07:30
Document Modified: 2018-02-02 15:07:30
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of availability.
DatesSubmit either electronic or written comments on Agency guidances at any time.
ContactRaanan A. Bloom, Environmental Assessment Team, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-2185, [email protected]
FR Citation81 FR 11811 
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