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50942 - Assessing Adhesion With Transdermal and Topical Delivery Systems for Abbreviated New Drug Applications; Revised Draft Guidance for Industry; Availability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)
Food and Drug Administration
Federal Register Volume 83, Issue 196 (October 10, 2018)
| Page Range | 50942-50943 | |
| FR Document | 2018-21959 |
[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] ----------------------------------------------------------------------- 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Assessing Adhesion With Transdermal and Topical Delivery Systems for Abbreviated New Drug Applications; Revised Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled ``Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs.'' This revised draft guidance supersedes the draft guidance entitled ``Assessing Adhesion with Transdermal Delivery Systems and Topical Patches for ANDAs,'' which was announced in the Federal Register on June 1, 2016. This revised draft guidance provides recommendations for the design and conduct of studies evaluating the adhesive performance of a transdermal or a topical delivery system (collectively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 The recommendations in this revised draft guidance relate exclusively to studies submitted in support of an abbreviated new drug application (ANDA). DATES: Submit either electronic or written comments on the revised draft guidance by December 10, 2018 to ensure that the Agency considers your comment on this revised draft guidance before it begins work on the final version of the guidance.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
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![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
VerDate Sep<11>2014 21:20 Oct 09, 2018 Jkt 247001 PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 E:\FR\FM\10OCN1.SGM 10OCN1](https://thefederalregister.org/doc/83_FR_51138/page/2.svg)
Document Created: 2018-10-10 17:39:11
Document Modified: 2018-10-10 17:39:11
| 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 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. | |
| 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. | |
| FR Citation | 83 FR 50942 |
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