83 FR 50943 - Product-Specific Guidances; Draft and Revised Draft Guidances 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 | 50943-50945 | |
| FR Document | 2018-21957 |
[Federal Register Volume 83, Number 196 (Wednesday, October 10, 2018)] [Notices] [Pages 50943-50945] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-21957] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0369] Product-Specific Guidances; Draft and Revised Draft Guidances 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 additional draft and revised draft product-specific guidances. The guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products'' that explained the process that would be used to make product-specific guidances available to the public on FDA's website. The guidances identified in this notice were developed using the process described in that guidance. DATES: Submit either electronic or written comments on the draft guidance by December 10, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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 [[Page 50944]] 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-2007-D-0369 for ``Product-Specific Guidances; Draft and Revised Draft Guidances for Industry.'' 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 guidances to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance documents. FOR FURTHER INFORMATION CONTACT: Wendy Good, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4714, Silver Spring, MD 20993-0002, 240-402-9682. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products'' that explained the process that would be used to make product-specific guidances available to the public on FDA's website at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. As described in that guidance, FDA adopted this process as a means to develop and disseminate product-specific guidances and provide a meaningful opportunity for the public to consider and comment on those guidances. Under that process, draft guidances are posted on FDA's website and announced periodically in the Federal Register. The public is encouraged to submit comments on those recommendations within 60 days of their announcement in the Federal Register. FDA considers any comments received and either publishes final guidances or publishes revised draft guidances for comment. Guidances were last announced in the Federal Register on September 14, 2018. This notice announces new or revised draft product-specific guidances that are being posted on FDA's website concurrently with FDA's new draft guidance for industry entitled ``Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs'' and FDA's revised draft guidance for industry entitled ``Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs.'' FDA recommends that applicants consult the relevant product-specific guidance, in conjunction with the guidances referenced above, when considering the design and conduct of studies that may be appropriate to support a topical delivery system product intended for submission in an ANDA. II. Drug Products for Which New Draft Product-Specific Guidances Are Available FDA is announcing the availability of new draft product-specific guidances for industry for drug products containing the following active ingredients: Table 1--New Draft Product-Specific Guidances for Drug Products ------------------------------------------------------------------------ ------------------------------------------------------------------------- Capsaicin Estradiol; Norethindrone acetate ------------------------------------------------------------------------ III. Drug Products for Which Revised Draft Product-Specific Guidances Are Available FDA is announcing the availability of revised draft product- specific guidances for industry for drug products containing the following active ingredients: Table 2--Revised Draft Product-Specific Guidances for Drug Products ------------------------------------------------------------------------ ------------------------------------------------------------------------- Buprenorphine Clonidine Diclofenac epolamine Estradiol (multiple Reference Listed Drugs) Ethinyl estradiol; Norelgestromin Fentanyl Granisetron Lidocaine Menthol; Methyl salicylate Methylphenidate Nicotine [[Page 50945]] Nitroglycerin (multiple Reference Listed Drugs) Oxybutynin (multiple Reference Listed Drugs) Rivastigmine Rotigotine Scopolamine Selegiline Testosterone ------------------------------------------------------------------------ For a complete history of previously published Federal Register notices related to product-specific guidances, go to https://www.regulations.gov and enter Docket No. FDA-2007-D-0369. These draft guidances are being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). These draft guidances, when finalized, will represent the current thinking of FDA on, among other things, the product-specific design of BE studies to support ANDAs. They do not establish any rights for any person and are 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. IV. Electronic Access Persons with access to the internet may obtain the draft guidances 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. 2018-21957 Filed 10-9-18; 8:45 am] BILLING CODE 4164-01-P
![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_51139/page/1.svg)
![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_51139/page/3.svg)
Document Created: 2018-10-10 17:38:05
Document Modified: 2018-10-10 17:38:05
| 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 | Wendy Good, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4714, Silver Spring, MD 20993-0002, 240-402-9682. | |
| FR Citation | 83 FR 50943 |
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