83_FR_51138 83 FR 50942 - Assessing Adhesion With Transdermal and Topical Delivery Systems for Abbreviated New Drug Applications; Revised Draft Guidance for Industry; Availability

83 FR 50942 - Assessing Adhesion With Transdermal and Topical Delivery Systems for Abbreviated New Drug Applications; Revised Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 196 (October 10, 2018)

Page Range50942-50943
FR Document2018-21959

The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled ``Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs.'' This revised draft guidance supersedes the draft guidance entitled ``Assessing Adhesion with Transdermal Delivery Systems and Topical Patches for ANDAs,'' which was announced in the Federal Register on June 1, 2016. This revised draft guidance provides recommendations for the design and conduct of studies evaluating the adhesive performance of a transdermal or a topical delivery system (collectively referred to as TDS). Depending on the objectives of a TDS product development program, applicants may choose to evaluate TDS adhesion in clinical studies performed to evaluate TDS adhesion only or in clinical studies performed with a combined purpose (e.g., for the simultaneous evaluation of adhesion and bioequivalence (BE) with pharmacokinetic (PK) endpoints). The recommendations in this revised draft guidance relate exclusively to studies submitted in support of an abbreviated new drug application (ANDA).

Federal Register, Volume 83 Issue 196 (Wednesday, October 10, 2018)
[Federal Register Volume 83, Number 196 (Wednesday, October 10, 2018)]
[Notices]
[Pages 50942-50943]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-21959]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA 2016-D-1254]


Assessing Adhesion With Transdermal and Topical Delivery Systems 
for Abbreviated New Drug Applications; Revised Draft Guidance for 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the availability of a revised draft guidance for industry entitled 
``Assessing Adhesion With Transdermal and Topical Delivery Systems for 
ANDAs.'' This revised draft guidance supersedes the draft guidance 
entitled ``Assessing Adhesion with Transdermal Delivery Systems and 
Topical Patches for ANDAs,'' which was announced in the Federal 
Register on June 1, 2016. This revised draft guidance provides 
recommendations for the design and conduct of studies evaluating the 
adhesive performance of a transdermal or a topical delivery system 
(collectively referred to as TDS). Depending on the objectives of a TDS 
product development program, applicants may choose to evaluate TDS 
adhesion in clinical studies performed to evaluate TDS adhesion only or 
in clinical studies performed with a combined purpose (e.g., for the 
simultaneous evaluation of adhesion and bioequivalence (BE) with 
pharmacokinetic (PK) endpoints). The recommendations in this revised 
draft guidance relate exclusively to studies submitted in support of an 
abbreviated new drug application (ANDA).

DATES: Submit either electronic or written comments on the revised 
draft guidance by December 10, 2018 to ensure that the Agency considers 
your comment on this revised 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 identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA 2016-D-1254 for ``Assessing Adhesion With Transdermal and Topical 
Delivery Systems for ANDAs.'' 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.
     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

[[Page 50943]]

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 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: Kris Andre, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 75, Rm. 4728, Silver Spring, MD 20993-0002, 240-402-7959.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a revised draft guidance for 
industry entitled ``Assessing Adhesion With Transdermal and Topical 
Delivery Systems for ANDAs.'' This revised draft guidance supersedes 
the draft guidance entitled ``Assessing Adhesion with Transdermal 
Delivery Systems and Topical Patches for ANDAs,'' which was announced 
in the Federal Register on June 1, 2016 (81 FR 35025). FDA received six 
comments on the draft guidance, which were considered before 
publication of this revised draft guidance.
    This revised draft guidance provides recommendations for the design 
and conduct of studies evaluating the adhesive performance of a TDS 
submitted in support of an ANDA. Depending on the objectives of a TDS 
product development program, applicants may choose to evaluate TDS 
adhesion in studies performed to evaluate TDS adhesion only or in 
studies performed with a combined purpose (e.g., for the simultaneous 
evaluation of adhesion and BE with PK endpoints). FDA recommends that 
applicants consult this revised draft guidance in conjunction with any 
relevant product-specific guidances for industry, when considering the 
design and conduct of studies that may be appropriate to support the BE 
of a proposed generic TDS product to its reference listed drug and/or 
reference standard product.
    During the product's labeled wear period, a TDS is reasonably 
expected to encounter torsional strains arising from body movements, 
changes in environmental temperature or humidity such as the daily 
exposure to water (e.g., during routine showering), and contact with 
clothing, bedding, or other surfaces. TDS products that do not maintain 
consistent and uniform adhesion with the skin during the labeled wear 
period can experience varying degrees of TDS detachment, including 
complete detachment, at different times during the product wear.
    When the adhesion characteristics of a TDS are not sufficiently 
robust, as evaluated against its labeled conditions of use, the TDS may 
exhibit variability in the surface area that is in contact with the 
skin. For example, when a TDS is partially detached, there may be 
uncertainty about the resulting drug delivery profile and, hence, 
uncertainty about the rate and extent of drug absorption from the TDS. 
When the potential for complete detachment of the TDS increases, the 
risk of unintentional exposure of the drug product to an unintended 
recipient (e.g., a household member who may be a child) also increases.
    This revised draft guidance is being issued consistent with FDA's 
good guidance practices regulation (21 CFR 10.115). The revised draft 
guidance, when finalized, will represent the current thinking of FDA on 
``Assessing Adhesion With Transdermal and Topical Delivery Systems for 
ANDAs.'' 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. Paperwork Reduction Act of 1995

    This revised draft guidance refers to previously approved 
collections of information found in FDA regulations. These collections 
of information 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 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 https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or 
https://www.regulations.gov.

    Dated: October 3, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-21959 Filed 10-9-18; 8:45 am]
 BILLING CODE 4164-01-P



                                              50942                     Federal Register / Vol. 83, No. 196 / Wednesday, October 10, 2018 / Notices

                                              interested persons to submit comments                   ‘‘Assessing Adhesion with Transdermal                    • Mail/Hand delivery/Courier (for
                                              regarding the 16 drug substances. Any                   Delivery Systems and Topical Patches                  written/paper submissions): Dockets
                                              comments received will be considered                    for ANDAs,’’ which was announced in                   Management Staff (HFA–305), Food and
                                              by HHS when it prepares a scientific                    the Federal Register on June 1, 2016.                 Drug Administration, 5630 Fishers
                                              and medical evaluation for drug                         This revised draft guidance provides                  Lane, Rm. 1061, Rockville, MD 20852.
                                              substances that is responsive to the                    recommendations for the design and                       • For written/paper comments
                                              WHO Questionnaire for these drug                        conduct of studies evaluating the                     submitted to the Dockets Management
                                              substances. HHS will forward such                       adhesive performance of a transdermal                 Staff, FDA will post your comment, as
                                              evaluation of these drug substances to                  or a topical delivery system (collectively            well as any attachments, except for
                                              WHO, for WHO’s consideration in                         referred to as TDS). Depending on the                 information submitted, marked and
                                              deciding whether to recommend                           objectives of a TDS product                           identified, as confidential, if submitted
                                              international control/decontrol of any of               development program, applicants may                   as detailed in ‘‘Instructions.’’
                                              these drug substances. Such control                     choose to evaluate TDS adhesion in                       Instructions: All submissions received
                                              could limit, among other things, the                    clinical studies performed to evaluate                must include the Docket No. FDA 2016–
                                              manufacture and distribution (import/                   TDS adhesion only or in clinical studies              D–1254 for ‘‘Assessing Adhesion With
                                              export) of these drug substances and                    performed with a combined purpose                     Transdermal and Topical Delivery
                                              could impose certain recordkeeping                      (e.g., for the simultaneous evaluation of             Systems for ANDAs.’’ Received
                                              requirements on them.                                   adhesion and bioequivalence (BE) with                 comments will be placed in the docket
                                                Although FDA is, through this notice,                 pharmacokinetic (PK) endpoints). The                  and, except for those submitted as
                                              requesting comments from interested                     recommendations in this revised draft                 ‘‘Confidential Submissions,’’ publicly
                                              persons, which will be considered by                    guidance relate exclusively to studies                viewable at https://www.regulations.gov
                                              HHS when it prepares an evaluation of                   submitted in support of an abbreviated                or at the Dockets Management Staff
                                              these drug substances, HHS will not                     new drug application (ANDA).                          between 9 a.m. and 4 p.m., Monday
                                              now make any recommendations to                                                                               through Friday.
                                                                                                      DATES: Submit either electronic or                       • Confidential Submissions—To
                                              WHO regarding whether any of these                      written comments on the revised draft                 submit a comment with confidential
                                              drugs should be subjected to                            guidance by December 10, 2018 to                      information that you do not wish to be
                                              international controls. Instead, HHS will               ensure that the Agency considers your                 made publicly available, submit your
                                              defer such consideration until WHO has                  comment on this revised draft guidance                comments only as a written/paper
                                              made official recommendations to the                    before it begins work on the final                    submission. You should submit two
                                              Commission on Narcotic Drugs, which                     version of the guidance.                              copies total. One copy will include the
                                              are expected to be made in mid-2018.                    ADDRESSES: You may submit comments                    information you claim to be confidential
                                              Any HHS position regarding                              on any guidance at any time as follows:               with a heading or cover note that states
                                              international control of these drug
                                                                                                      Electronic Submissions                                ‘‘THIS DOCUMENT CONTAINS
                                              substances will be preceded by another
                                                                                                                                                            CONFIDENTIAL INFORMATION.’’ The
                                              Federal Register notice soliciting public                 Submit electronic comments in the                   Agency will review this copy, including
                                              comments, as required by paragraph                      following way:                                        the claimed confidential information, in
                                              (d)(2)(B) of the CSA.                                     • Federal eRulemaking Portal:                       its consideration of comments. The
                                                Dated: October 3, 2018.                               https://www.regulations.gov. Follow the               second copy, which will have the
                                              Leslie Kux,                                             instructions for submitting comments.                 claimed confidential information
                                              Associate Commissioner for Policy.                      Comments submitted electronically,                    redacted/blacked out, will be available
                                              [FR Doc. 2018–21954 Filed 10–9–18; 8:45 am]             including attachments, to https://                    for public viewing and posted on
                                              BILLING CODE 4164–01–P
                                                                                                      www.regulations.gov will be posted to                 https://www.regulations.gov. Submit
                                                                                                      the docket unchanged. Because your                    both copies to the Dockets Management
                                                                                                      comment will be made public, you are                  Staff. If you do not wish your name and
                                              DEPARTMENT OF HEALTH AND                                solely responsible for ensuring that your             contact information to be made publicly
                                              HUMAN SERVICES                                          comment does not include any                          available, you can provide this
                                                                                                      confidential information that you or a                information on the cover sheet and not
                                              Food and Drug Administration                            third party may not wish to be posted,                in the body of your comments and you
                                                                                                      such as medical information, your or                  must identify this information as
                                              [Docket No. FDA 2016–D–1254]
                                                                                                      anyone else’s Social Security number, or              ‘‘confidential.’’
                                              Assessing Adhesion With Transdermal                     confidential business information, such                  Any information marked as
                                              and Topical Delivery Systems for                        as a manufacturing process. Please note               ‘‘confidential’’ will not be disclosed
                                              Abbreviated New Drug Applications;                      that if you include your name, contact                except in accordance with 21 CFR 10.20
                                              Revised Draft Guidance for Industry;                    information, or other information that                and other applicable disclosure law. For
                                              Availability                                            identifies you in the body of your                    more information about FDA’s posting
                                                                                                      comments, that information will be                    of comments to public dockets, see 80
                                              AGENCY:    Food and Drug Administration,                posted on https://www.regulations.gov.                FR 56469, September 18, 2015, or access
                                              HHS.                                                      • If you want to submit a comment                   the information at: https://www.gpo.gov/
                                              ACTION:   Notice of availability.                       with confidential information that you                fdsys/pkg/FR-2015-09-18/pdf/2015-
                                                                                                      do not wish to be made available to the               23389.pdf.
                                              SUMMARY:  The Food and Drug                             public, submit the comment as a                          Docket: For access to the docket to
amozie on DSK3GDR082PROD with NOTICES1




                                              Administration (FDA or Agency) is                       written/paper submission and in the                   read background documents or the
                                              announcing the availability of a revised                manner detailed (see ‘‘Written/Paper                  electronic and written/paper comments
                                              draft guidance for industry entitled                    Submissions’’ and ‘‘Instructions’’).                  received, go to https://
                                              ‘‘Assessing Adhesion With Transdermal                                                                         www.regulations.gov and insert the
                                              and Topical Delivery Systems for                        Written/Paper Submissions                             docket number, found in brackets in the
                                              ANDAs.’’ This revised draft guidance                      Submit written/paper submissions as                 heading of this document, into the
                                              supersedes the draft guidance entitled                  follows:                                              ‘‘Search’’ box and follow the prompts


                                         VerDate Sep<11>2014   21:20 Oct 09, 2018   Jkt 247001   PO 00000   Frm 00059   Fmt 4703   Sfmt 4703   E:\FR\FM\10OCN1.SGM   10OCN1


                                                                        Federal Register / Vol. 83, No. 196 / Wednesday, October 10, 2018 / Notices                                                 50943

                                              and/or go to the Dockets Management                     body movements, changes in                              Dated: October 3, 2018.
                                              Staff, 5630 Fishers Lane, Rm. 1061,                     environmental temperature or humidity                 Leslie Kux,
                                              Rockville, MD 20852.                                    such as the daily exposure to water (e.g.,            Associate Commissioner for Policy.
                                                You may submit comments on any                        during routine showering), and contact                [FR Doc. 2018–21959 Filed 10–9–18; 8:45 am]
                                              guidance at any time (see 21 CFR                        with clothing, bedding, or other                      BILLING CODE 4164–01–P
                                              10.115(g)(5)).                                          surfaces. TDS products that do not
                                                Submit written requests for single                    maintain consistent and uniform
                                              copies of this guidance to the Division                 adhesion with the skin during the                     DEPARTMENT OF HEALTH AND
                                              of Drug Information, Center for Drug                    labeled wear period can experience                    HUMAN SERVICES
                                              Evaluation and Research, Food and                       varying degrees of TDS detachment,
                                              Drug Administration, 10001 New                                                                                Food and Drug Administration
                                                                                                      including complete detachment, at
                                              Hampshire Ave., Hillandale Building,
                                                                                                      different times during the product wear.              [Docket No. FDA–2007–D–0369]
                                              4th Floor, Silver Spring, MD 20993–
                                              0002. Send one self-addressed adhesive                     When the adhesion characteristics of               Product-Specific Guidances; Draft and
                                              label to assist that office in processing               a TDS are not sufficiently robust, as                 Revised Draft Guidances for Industry;
                                              your requests. See the SUPPLEMENTARY                    evaluated against its labeled conditions              Availability
                                              INFORMATION section for electronic                      of use, the TDS may exhibit variability
                                              access to the guidance document.                        in the surface area that is in contact                AGENCY:    Food and Drug Administration,
                                              FOR FURTHER INFORMATION CONTACT: Kris                   with the skin. For example, when a TDS                HHS.
                                              Andre, Center for Drug Evaluation and                   is partially detached, there may be                   ACTION:   Notice of availability.
                                              Research, Food and Drug                                 uncertainty about the resulting drug
                                              Administration, 10903 New Hampshire                     delivery profile and, hence, uncertainty              SUMMARY:   The Food and Drug
                                              Ave., Bldg. 75, Rm. 4728, Silver Spring,                about the rate and extent of drug                     Administration (FDA or Agency) is
                                              MD 20993–0002, 240–402–7959.                                                                                  announcing the availability of
                                                                                                      absorption from the TDS. When the
                                                                                                                                                            additional draft and revised draft
                                              SUPPLEMENTARY INFORMATION:                              potential for complete detachment of
                                                                                                                                                            product-specific guidances. The
                                                                                                      the TDS increases, the risk of
                                              I. Background                                                                                                 guidances provide product-specific
                                                                                                      unintentional exposure of the drug                    recommendations on, among other
                                                 FDA is announcing the availability of                product to an unintended recipient (e.g.,             things, the design of bioequivalence
                                              a revised draft guidance for industry                   a household member who may be a                       (BE) studies to support abbreviated new
                                              entitled ‘‘Assessing Adhesion With                      child) also increases.                                drug applications (ANDAs). In the
                                              Transdermal and Topical Delivery
                                                                                                         This revised draft guidance is being               Federal Register of June 11, 2010, FDA
                                              Systems for ANDAs.’’ This revised draft
                                                                                                      issued consistent with FDA’s good                     announced the availability of a guidance
                                              guidance supersedes the draft guidance
                                                                                                      guidance practices regulation (21 CFR                 for industry entitled ‘‘Bioequivalence
                                              entitled ‘‘Assessing Adhesion with
                                                                                                      10.115). The revised draft guidance,                  Recommendations for Specific
                                              Transdermal Delivery Systems and
                                                                                                      when finalized, will represent the                    Products’’ that explained the process
                                              Topical Patches for ANDAs,’’ which was
                                                                                                      current thinking of FDA on ‘‘Assessing                that would be used to make product-
                                              announced in the Federal Register on
                                                                                                      Adhesion With Transdermal and                         specific guidances available to the
                                              June 1, 2016 (81 FR 35025). FDA
                                                                                                      Topical Delivery Systems for ANDAs.’’                 public on FDA’s website. The guidances
                                              received six comments on the draft
                                                                                                      It does not establish any rights for any              identified in this notice were developed
                                              guidance, which were considered before
                                                                                                      person and is not binding on FDA or the               using the process described in that
                                              publication of this revised draft
                                                                                                      public. You can use an alternative                    guidance.
                                              guidance.
                                                 This revised draft guidance provides                 approach if it satisfies the requirements             DATES:  Submit either electronic or
                                              recommendations for the design and                      of the applicable statutes and                        written comments on the draft guidance
                                              conduct of studies evaluating the                       regulations. This guidance is not subject             by December 10, 2018 to ensure that the
                                              adhesive performance of a TDS                           to Executive Order 12866.                             Agency considers your comment on this
                                              submitted in support of an ANDA.                                                                              draft guidance before it begins work on
                                                                                                      II. Paperwork Reduction Act of 1995                   the final version of the guidance.
                                              Depending on the objectives of a TDS
                                              product development program,                              This revised draft guidance refers to               ADDRESSES: You may submit comments
                                              applicants may choose to evaluate TDS                   previously approved collections of                    on any guidance at any time as follows:
                                              adhesion in studies performed to                        information found in FDA regulations.
                                              evaluate TDS adhesion only or in                                                                              Electronic Submissions
                                                                                                      These collections of information are
                                              studies performed with a combined                       subject to review by the Office of                      Submit electronic comments in the
                                              purpose (e.g., for the simultaneous                     Management and Budget (OMB) under                     following way:
                                              evaluation of adhesion and BE with PK                   the Paperwork Reduction Act of 1995                     • Federal eRulemaking Portal:
                                              endpoints). FDA recommends that                                                                               https://www.regulations.gov. Follow the
                                                                                                      (44 U.S.C. 3501–3520). The collections
                                              applicants consult this revised draft                                                                         instructions for submitting comments.
                                                                                                      of information in 21 CFR 314 have been
                                              guidance in conjunction with any                                                                              Comments submitted electronically,
                                                                                                      approved under OMB control number
                                              relevant product-specific guidances for                                                                       including attachments, to https://
                                                                                                      0910–0001.
                                              industry, when considering the design                                                                         www.regulations.gov will be posted to
                                              and conduct of studies that may be                      III. Electronic Access                                the docket unchanged. Because your
amozie on DSK3GDR082PROD with NOTICES1




                                              appropriate to support the BE of a                                                                            comment will be made public, you are
                                              proposed generic TDS product to its                       Persons with access to the internet                 solely responsible for ensuring that your
                                              reference listed drug and/or reference                  may obtain the guidance at either                     comment does not include any
                                              standard product.                                       https://www.fda.gov/Drugs/Guidance                    confidential information that you or a
                                                 During the product’s labeled wear                    ComplianceRegulatoryInformation/                      third party may not wish to be posted,
                                              period, a TDS is reasonably expected to                 Guidances/default.htm or https://                     such as medical information, your or
                                              encounter torsional strains arising from                www.regulations.gov.                                  anyone else’s Social Security number, or


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Document Created: 2018-10-10 17:39:11
Document Modified: 2018-10-10 17:39:11
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 the revised draft guidance by December 10, 2018 to ensure that the Agency considers your comment on this revised draft guidance before it begins work on the final version of the guidance.
ContactKris Andre, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4728, Silver Spring, MD 20993-0002, 240-402-7959.
FR Citation83 FR 50942 

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