83 FR 50945 - Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for Abbreviated New Drug Applications; Draft Guidance for Industry; Availability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 | 50945-50946 | |
| FR Document | 2018-21958 |
[Federal Register Volume 83, Number 196 (Wednesday, October 10, 2018)] [Notices] [Pages 50945-50946] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-21958] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-D-3546] Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for Abbreviated New Drug Applications; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs.'' This draft guidance provides recommendations for the design and conduct of studies to evaluate the in vivo skin irritation and sensitization (I/S) potential of a proposed transdermal or topical delivery system (collectively referred to as TDS). The recommendations in this draft guidance relate exclusively to studies submitted in support of an abbreviated new drug application (ANDA). DATES: Submit either electronic or written comments on the draft guidance by December 10, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2018-D-3546 for ``Assessing the Irritation and Sensitization Potential of 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 and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food [[Page 50946]] and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Diana Solana-Sodeinde, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 2724, Silver Spring, MD 20993-0002, 240- 402-3908. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ``Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs.'' The components and composition of a TDS formulation, including the nature of the drug substance and/or the occlusivity of the TDS materials, in conjunction with other factors such as the environmental humidity or the condition of the skin, may have the potential to irritate the skin or lead to a sensitization reaction. Such reactions can be unpleasant to the patient and may affect patient compliance, skin permeability, and/or adhesion of the TDS to the skin. The collective consequence of these potential effects could create uncertainty about the resulting drug delivery profile and uncertainty about the rate and extent of drug absorption from the TDS. Therefore, applicants should perform a comparative assessment of the test (T) and reference (R) TDS products using an appropriately designed skin I/S study with human subjects to demonstrate that the potential for a skin irritation or sensitization reaction with the T TDS is no worse than the reaction observed with the R TDS. This draft guidance provides recommendations for the design and conduct of studies to evaluate the in vivo skin I/S potential of a proposed TDS. The recommendations in this draft guidance relate exclusively to studies submitted in support of an ANDA. The Agency is seeking comments on the recommendations reflected in the draft guidance announced in this notice. In addition, FDA invites comments on the scales and any alternative approaches, including those recommended by international regulatory agencies, that may have been used with success for the comparative assessment of the I/S potential for proposed generic TDS products. FDA also specifically invites comments regarding the comparative assessment of sensitization itself, i.e., whether there are clinical scenarios where a comparative sensitization assessment may be uninformative when done in addition to a comparative irritation assessment. This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on ``Assessing the Irritation and Sensitization Potential of 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 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 314.94 have been approved under OMB control number 0910-0001. III. Electronic Access Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov. Dated: October 3, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-21958 Filed 10-9-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 196 / Wednesday, October 10, 2018 / Notices 50945
TABLE 2—REVISED DRAFT PRODUCT- ‘‘Assessing the Irritation and identified, as confidential, if submitted
SPECIFIC GUIDANCES FOR DRUG Sensitization Potential of Transdermal as detailed in ‘‘Instructions.’’
PRODUCTS—Continued and Topical Delivery Systems for Instructions: All submissions received
ANDAs.’’ This draft guidance provides must include the Docket No. FDA–
Nitroglycerin (multiple Reference Listed recommendations for the design and 2018–D–3546 for ‘‘Assessing the
Drugs) conduct of studies to evaluate the in Irritation and Sensitization Potential of
Oxybutynin (multiple Reference Listed Drugs) vivo skin irritation and sensitization Transdermal and Topical Delivery
Rivastigmine (I/S) potential of a proposed transdermal Systems for ANDAs.’’ Received
Rotigotine comments will be placed in the docket
Scopolamine
or topical delivery system (collectively
referred to as TDS). The and, except for those submitted as
Selegiline
Testosterone recommendations in this draft guidance ‘‘Confidential Submissions,’’ publicly
relate exclusively to studies submitted viewable at https://www.regulations.gov
For a complete history of previously in support of an abbreviated new drug or at the Dockets Management Staff
published Federal Register notices application (ANDA). between 9 a.m. and 4 p.m., Monday
related to product-specific guidances, go DATES: Submit either electronic or
through Friday.
• Confidential Submissions—To
to https://www.regulations.gov and written comments on the draft guidance
submit a comment with confidential
enter Docket No. FDA–2007–D–0369. by December 10, 2018 to ensure that the
information that you do not wish to be
These draft guidances are being Agency considers your comment on this
made publicly available, submit your
issued consistent with FDA’s good draft guidance before it begins work on
comments only as a written/paper
guidance practices regulation (21 CFR the final version of the guidance.
submission. You should submit two
10.115). These draft guidances, when ADDRESSES: You may submit comments copies total. One copy will include the
finalized, will represent the current on any guidance at any time as follows: information you claim to be confidential
thinking of FDA on, among other things,
Electronic Submissions with a heading or cover note that states
the product-specific design of BE
‘‘THIS DOCUMENT CONTAINS
studies to support ANDAs. They do not Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The
establish any rights for any person and following way: Agency will review this copy, including
are not binding on FDA or the public. • Federal eRulemaking Portal: the claimed confidential information, in
You can use an alternative approach if https://www.regulations.gov. Follow the its consideration of comments. The
it satisfies the requirements of the instructions for submitting comments. second copy, which will have the
applicable statutes and regulations. This Comments submitted electronically, claimed confidential information
guidance is not subject to Executive including attachments, to https:// redacted/blacked out, will be available
Order 12866. www.regulations.gov will be posted to for public viewing and posted on
IV. Electronic Access the docket unchanged. Because your https://www.regulations.gov. Submit
comment will be made public, you are both copies to the Dockets Management
Persons with access to the internet solely responsible for ensuring that your Staff. If you do not wish your name and
may obtain the draft guidances at either comment does not include any contact information to be made publicly
https://www.fda.gov/Drugs/Guidance confidential information that you or a available, you can provide this
ComplianceRegulatoryInformation/ third party may not wish to be posted, information on the cover sheet and not
Guidances/default.htm or https:// such as medical information, your or in the body of your comments and you
www.regulations.gov. anyone else’s Social Security number, or must identify this information as
Dated: October 3, 2018. confidential business information, such ‘‘confidential.’’ Any information marked
Leslie Kux, as a manufacturing process. Please note as ‘‘confidential’’ will not be disclosed
Associate Commissioner for Policy. that if you include your name, contact except in accordance with 21 CFR 10.20
[FR Doc. 2018–21957 Filed 10–9–18; 8:45 am]
information, or other information that and other applicable disclosure law. For
identifies you in the body of your more information about FDA’s posting
BILLING CODE 4164–01–P
comments, that information will be of comments to public dockets, see 80
posted on https://www.regulations.gov. FR 56469, September 18, 2015, or access
DEPARTMENT OF HEALTH AND • If you want to submit a comment the information at: https://www.gpo.gov/
HUMAN SERVICES with confidential information that you fdsys/pkg/FR-2015-09-18/pdf/2015-
do not wish to be made available to the 23389.pdf.
Food and Drug Administration public, submit the comment as a Docket: For access to the docket to
written/paper submission and in the read background documents or the
[Docket No. FDA–2018–D–3546]
manner detailed (see ‘‘Written/Paper electronic and written/paper comments
Assessing the Irritation and Submissions’’ and ‘‘Instructions’’). received, go to https://
Sensitization Potential of Transdermal Written/Paper Submissions www.regulations.gov and insert the
and Topical Delivery Systems for docket number, found in brackets in the
Abbreviated New Drug Applications; Submit written/paper submissions as heading of this document, into the
Draft Guidance for Industry; follows: ‘‘Search’’ box and follow the prompts
Availability • Mail/Hand delivery/Courier (for and/or go to the Dockets Management
written/paper submissions): Dockets Staff, 5630 Fishers Lane, Rm. 1061,
AGENCY: Food and Drug Administration, Management Staff (HFA–305), Food and Rockville, MD 20852.
amozie on DSK3GDR082PROD with NOTICES1
HHS. Drug Administration, 5630 Fishers You may submit comments on any
ACTION: Notice of availability. Lane, Rm. 1061, Rockville, MD 20852. guidance at any time (see 21 CFR
• For written/paper comments 10.115(g)(5)).
SUMMARY: The Food and Drug submitted to the Dockets Management Submit written requests for single
Administration (FDA or Agency) is Staff, FDA will post your comment, as copies of the draft guidance to the
announcing the availability of a draft well as any attachments, except for Division of Drug Information, Center for
guidance for industry entitled information submitted, marked and Drug Evaluation and Research, Food
VerDate Sep<11>2014 21:20 Oct 09, 2018 Jkt 247001 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 E:\FR\FM\10OCN1.SGM 10OCN1](https://thefederalregister.org/doc/83_FR_51141/page/1.svg)
![50946 Federal Register / Vol. 83, No. 196 / Wednesday, October 10, 2018 / Notices
and Drug Administration, 10001 New proposed generic TDS products. FDA the discussions could disclose
Hampshire Ave., Hillandale Building, also specifically invites comments confidential trade secrets or commercial
4th Floor, Silver Spring, MD 20993– regarding the comparative assessment of property such as patentable material,
0002. Send one self-addressed adhesive sensitization itself, i.e., whether there and personal information concerning
label to assist that office in processing are clinical scenarios where a individuals associated with the grant
your requests. See the SUPPLEMENTARY comparative sensitization assessment applications, the disclosure of which
INFORMATION section for electronic may be uninformative when done in would constitute a clearly unwarranted
access to the draft guidance document. addition to a comparative irritation invasion of personal privacy.
FOR FURTHER INFORMATION CONTACT: assessment. Name of Committee: Center for Scientific
Diana Solana-Sodeinde, Center for Drug This draft guidance is being issued Review Special Emphasis Panel;
Evaluation and Research, Food and consistent with FDA’s good guidance Neurobiology of Learning and Memory.
Drug Administration, 10903 New practices regulation (21 CFR 10.115). Date: October 24, 2018.
Hampshire Ave., Bldg. 75, Rm. 2724, The draft guidance, when finalized, will Time: 8:00 a.m. to 5:00 p.m.
represent the current thinking of FDA Agenda: To review and evaluate grant
Silver Spring, MD 20993–0002, 240– applications.
402–3908. on ‘‘Assessing the Irritation and
Place: The Fairmont Washington, DC, 2401
SUPPLEMENTARY INFORMATION:
Sensitization Potential of Transdermal M Street NW, Washington, DC 20037.
and Topical Delivery Systems for Contact Person: Alexei Kondratyev, Ph.D.,
I. Background ANDAs.’’ It does not establish any rights Scientific Review Officer, Center for
FDA is announcing the availability of for any person and is not binding on Scientific Review, National Institutes of
a draft guidance for industry entitled FDA or the public. You can use an Health, 6701 Rockledge Drive, Room 5200,
alternative approach if it satisfies the MSC 7846, Bethesda, MD 20892, 301–435–
‘‘Assessing the Irritation and 1785, kondratyevad@csr.nih.gov.
Sensitization Potential of Transdermal requirements of the applicable statutes
and regulations. This guidance is not Name of Committee: Center for Scientific
and Topical Delivery Systems for Review Special Emphasis Panel; PAR Panel:
ANDAs.’’ subject to Executive Order 12866.
Health Disparities in and Caregiving for
The components and composition of II. Paperwork Reduction Act of 1995 Alzheimer’s Disease.
a TDS formulation, including the nature Date: November 2, 2018.
This draft guidance refers to Time: 8:00 a.m. to 5:00 p.m.
of the drug substance and/or the
previously approved collections of Agenda: To review and evaluate grant
occlusivity of the TDS materials, in
information found in FDA regulations. applications.
conjunction with other factors such as
These collections of information are Place: National Institutes of Health, 6701
the environmental humidity or the Rockledge Drive, Bethesda, MD 20892.
subject to review by the Office of
condition of the skin, may have the Contact Person: Gabriel B. Fosu, Ph.D.,
Management and Budget (OMB) under
potential to irritate the skin or lead to Scientific Review Officer, Center for
the Paperwork Reduction Act of 1995
a sensitization reaction. Such reactions Scientific Review, National Institutes of
(44 U.S.C. 3501–3520). The collections Health, 6701 Rockledge Drive, Room 3108,
can be unpleasant to the patient and
of information in 21 CFR 314.94 have MSC 7808, Bethesda, MD 20892, (301) 435–
may affect patient compliance, skin
been approved under OMB control 3562, fosug@csr.nih.gov.
permeability, and/or adhesion of the
number 0910–0001. Name of Committee: Center for Scientific
TDS to the skin. The collective
consequence of these potential effects Review Special Emphasis Panel; Fellowship:
III. Electronic Access
Infectious Diseases and Microbiology.
could create uncertainty about the Persons with access to the internet Date: November 5–6, 2018.
resulting drug delivery profile and may obtain the draft guidance at either Time: 8:00 a.m. to 5:00 p.m.
uncertainty about the rate and extent of https://www.fda.gov/Drugs/Guidance Agenda: To review and evaluate grant
drug absorption from the TDS. ComplianceRegulatoryInformation/ applications.
Therefore, applicants should perform a Place: Hotel Palomar, 2121 P Street NW,
Guidances/default.htm or https:// Washington, DC 20037.
comparative assessment of the test (T) www.regulations.gov.
and reference (R) TDS products using an Contact Person: Tamara Lyn McNealy,
Dated: October 3, 2018. Ph.D., Scientific Review Officer, Center for
appropriately designed skin I/S study Scientific Review, National Institutes of
with human subjects to demonstrate Leslie Kux,
Health, 6701 Rockledge Drive, Room 3188,
that the potential for a skin irritation or Associate Commissioner for Policy. Bethesda, MD 20892, 301–827–2372,
sensitization reaction with the T TDS is [FR Doc. 2018–21958 Filed 10–9–18; 8:45 am] tamara.mcnealy@nih.gov.
no worse than the reaction observed BILLING CODE 4164–01–P Name of Committee: Center for Scientific
with the R TDS. Review Special Emphasis Panel;
This draft guidance provides Fellowships: Risk, Prevention and Health
recommendations for the design and DEPARTMENT OF HEALTH AND Behavior.
conduct of studies to evaluate the in HUMAN SERVICES Date: November 5–6, 2018.
Time: 8:00 a.m. to 5:00 p.m.
vivo skin I/S potential of a proposed Agenda: To review and evaluate grant
TDS. The recommendations in this draft National Institutes of Health
applications.
guidance relate exclusively to studies Place: Embassy Suites at the Chevy Chase
Center for Scientific Review; Notice of
submitted in support of an ANDA. Pavilion, 4300 Military Road NW,
Closed Meetings
The Agency is seeking comments on Washington, DC 20015.
the recommendations reflected in the Pursuant to section 10(d) of the Contact Person: Martha M. Faraday, Ph.D.,
draft guidance announced in this notice. Federal Advisory Committee Act, as Scientific Review Officer, Center for
amozie on DSK3GDR082PROD with NOTICES1
In addition, FDA invites comments on Scientific Review, National Institutes of
amended, notice is hereby given of the Health, 6701 Rockledge Drive, Room 3110,
the scales and any alternative following meetings. MSC 7808, Bethesda, MD 20892, (301) 435–
approaches, including those The meetings will be closed to the 3575, faradaym@csr.nih.gov.
recommended by international public in accordance with the Name of Committee: Center for Scientific
regulatory agencies, that may have been provisions set forth in sections Review Special Emphasis Panel; Member
used with success for the comparative 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Conflict: Bioengineering Sciences and
assessment of the I/S potential for as amended. The grant applications and Technologies.
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Document Created: 2018-10-10 17:35:35
Document Modified: 2018-10-10 17:35:35
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| Dates | Submit either electronic or written comments on the draft guidance by December 10, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. | |
| Contact | Diana Solana-Sodeinde, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 2724, Silver Spring, MD 20993-0002, 240- 402-3908. | |
| FR Citation | 83 FR 50945 |
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