83 FR 23689 - Acne Vulgaris: Establishing Effectiveness of Drugs Intended for Treatment; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 99 (May 22, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 99 (May 22, 2018)
| Page Range | 23689-23690 | |
| FR Document | 2018-10928 |
[Federal Register Volume 83, Number 99 (Tuesday, May 22, 2018)] [Notices] [Pages 23689-23690] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-10928] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2005-D-0461] Acne Vulgaris: Establishing Effectiveness of Drugs Intended for Treatment; 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 guidance for industry entitled ``Acne Vulgaris: Establishing Effectiveness of Drugs Intended for Treatment.'' This guidance provides recommendations to industry for establishing the clinical effectiveness of drugs for the treatment of acne vulgaris (acne). This guidance finalizes the draft guidance for industry entitled ``Acne Vulgaris: Developing Drugs for Treatment,'' issued September 19, 2005. DATES: The announcement of the guidance is published in the Federal Register on May 22, 2018. ADDRESSES: You may submit either electronic or written comments on Agency guidances 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. [[Page 23690]] 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-2005-D-0461 for ``Acne Vulgaris: Establishing Effectiveness of Drugs Intended for Treatment; Guidance 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 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: Strother D. Dixon, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 5168, Silver Spring, MD 20993-0002, 301- 796-1015. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled ``Acne Vulgaris: Establishing Effectiveness of Drugs Intended for Treatment.'' This guidance provides recommendations to industry for establishing the clinical effectiveness of drugs for the treatment of acne. This guidance finalizes the draft guidance for industry entitled ``Acne Vulgaris: Developing Drugs for Treatment,'' issued September 19, 2005 (70 FR 54945). Comments on the draft guidance were considered while finalizing this guidance. Changes made to the draft guidance include reformatting into a bulleted presentation and streamlining of information to core recommendations. This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on establishing the effectiveness of drugs intended to treat acne. 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. 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: May 17, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-10928 Filed 5-21-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 99 / Tuesday, May 22, 2018 / Notices 23689
and/or go to the Dockets Management interaction potential? Please provide the Dated: May 17, 2018.
Staff, 5630 Fishers Lane, Rm. 1061, rationale for your suggestions. Leslie Kux,
Rockville, MD 20852. 2. When conducting pH-dependent Associate Commissioner for Policy.
FOR FURTHER INFORMATION CONTACT: DDI assessments: [FR Doc. 2018–10927 Filed 5–21–18; 8:45 am]
Xinning Yang, Office of Clinical BILLING CODE 4164–01–P
a. What are the utilities and
Pharmacology, Center for Drug
limitations of different approaches to
Evaluation and Research, Food and
evaluating DDIs (e.g., in silico, in vitro, DEPARTMENT OF HEALTH AND
Drug Administration, 10903 New
and dedicated clinical studies, as well HUMAN SERVICES
Hampshire Ave., Silver Spring, MD
as population pharmacokinetic
20993–0002, 301–796–7412,
Xinning.Yang@fda.hhs.gov. analyses)? Food and Drug Administration
SUPPLEMENTARY INFORMATION: b. What are the study design
[Docket No. FDA–2005–D–0461]
considerations (e.g., study population,
I. Background choice of ARAs, dosing regimen and Acne Vulgaris: Establishing
FDA is establishing a public docket to administration, and pharmacokinetic Effectiveness of Drugs Intended for
assist with the development of a policy sampling) for the in vivo assessments Treatment; Guidance for Industry;
or guidance document on the discussed in 2a above? Please describe Availability
assessment of pH-dependent DDIs. In the rationale for any design
October 2017, FDA published the In considerations proposed. AGENCY: Food and Drug Administration,
Vitro Studies draft guidance and the HHS.
c. Can we extrapolate the findings
Clinical Drug Interaction Studies draft from a clinical DDI study with one ARA ACTION: Notice of availability.
guidance (Refs. 1 and 2). These draft drug (a PPI, H2 blocker, or antacid) to
guidance documents assist drug SUMMARY: The Food and Drug
anticipate the DDI potential for other Administration (FDA or Agency) is
developers in the planning and ARAs in the same class or in a different
evaluation of DDI studies during drug announcing the availability of a
class? Please provide the rationale for guidance for industry entitled ‘‘Acne
development. These draft guidance your proposal.
documents also focus on enzyme- and Vulgaris: Establishing Effectiveness of
transporter-based DDIs but do not FDA will consider all information and Drugs Intended for Treatment.’’ This
include a framework for assessing DDIs comments submitted in a timely manner guidance provides recommendations to
caused by drug-induced changes in (see ADDRESSES). industry for establishing the clinical
gastric pH. effectiveness of drugs for the treatment
III. References of acne vulgaris (acne). This guidance
Acid-reducing agents (ARAs) such as
antacids, histamine H2-receptor The following references are on finalizes the draft guidance for industry
antagonists (H2 blockers), and proton display in the Dockets Management entitled ‘‘Acne Vulgaris: Developing
pump inhibitors (PPIs) are widely used, Staff (see ADDRESSES) and are available Drugs for Treatment,’’ issued September
and many of these products are for viewing by interested persons 19, 2005.
available over the counter (Refs. 3 and between 9 a.m. and 4 p.m., Monday DATES: The announcement of the
4). For a drug whose solubility is pH- through Friday; they are also available guidance is published in the Federal
dependent, concomitant administration electronically at https:// Register on May 22, 2018.
with an ARA may affect its absorption www.regulations.gov. FDA has verified ADDRESSES: You may submit either
and systemic exposure, potentially the website addresses, as of the date this electronic or written comments on
resulting in loss of efficacy or, in some document publishes in the Federal Agency guidances at any time as
cases, increased toxicity. Therefore, it is Register, but websites are subject to follows:
important to assess a drug’s change over time.
Electronic Submissions
susceptibility to pH-dependent DDIs 1. FDA Draft Guidance for Industry, ‘‘In Vitro
during drug development, characterize Metabolism- and Transporter-Mediated
Submit electronic comments in the
the DDI effect with clinical studies Drug-Drug Interaction Studies,’’ October
following way:
when needed, and communicate study 2017. Available at https://www.fda.gov/ • Federal eRulemaking Portal:
results in the drug labeling (Ref. 4). FDA downloads/Drugs/Guidance https://www.regulations.gov. Follow the
is seeking public input to inform a ComplianceRegulatoryInformation/ instructions for submitting comments.
framework to assess pH-dependent Guidances/UCM581965.pdf. Comments submitted electronically,
DDIs. 2. FDA Draft Guidance for Industry, ‘‘Clinical including attachments, to https://
Drug Interaction Studies—Study Design, www.regulations.gov will be posted to
II. Request for Information and the docket unchanged. Because your
Comments Data Analysis, and Clinical
Implications,’’ October 2017. Available comment will be made public, you are
Interested persons are invited to at https://www.fda.gov/downloads/drugs solely responsible for ensuring that your
provide detailed information and /guidances/ucm292362.pdf. comment does not include any
comments on approaches to assess pH- 3. Centers for Disease Control and confidential information that you or a
dependent DDIs. You may also submit Prevention’s (CDC’s) National Health and third party may not wish to be posted,
information and comments in a Nutrition Examination Survey. Available such as medical information, your or
confidential manner (see Instructions in at https://www.cdc.gov/nchs/data/hus/ anyone else’s Social Security number, or
amozie on DSK3GDR082PROD with NOTICES1
the ADDRESSES section). FDA is hus16.pdf#079 (accessed May 16, 2018). confidential business information, such
particularly interested in responses to 4. Zhang, L., F. Wu, S.C. Lee, et al., ‘‘pH- as a manufacturing process. Please note
the following overarching questions: Dependent Drug-Drug Interactions for that if you include your name, contact
1. What are the characteristics of Weak Base Drugs: Potential Implications information, or other information that
drugs that are susceptible to pH- for New Drug Development,’’ Clinical identifies you in the body of your
dependent DDIs? Can a stepwise Pharmacology and Therapeutics, comments, that information will be
approach be applied to evaluate the 96(2):266–277, 2014. posted on https://www.regulations.gov.
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![23690 Federal Register / Vol. 83, No. 99 / Tuesday, May 22, 2018 / Notices
• If you want to submit a comment the information at: https://www.gpo.gov/ regulations. This guidance is not subject
with confidential information that you fdsys/pkg/FR-2015-09-18/pdf/2015- to Executive Order 12866.
do not wish to be made available to the 23389.pdf.
II. Electronic Access
public, submit the comment as a Docket: For access to the docket to
written/paper submission and in the read background documents or the Persons with access to the internet
manner detailed (see ‘‘Written/Paper electronic and written/paper comments may obtain the guidance at either
Submissions’’ and ‘‘Instructions’’). received, go to https:// https://www.fda.gov/Drugs/
www.regulations.gov and insert the GuidanceCompliance
Written/Paper Submissions
docket number, found in brackets in the RegulatoryInformation/Guidances/
Submit written/paper submissions as heading of this document, into the default.htm or https://
follows: ‘‘Search’’ box and follow the prompts www.regulations.gov.
• Mail/Hand delivery/Courier (for and/or go to the Dockets Management Dated: May 17, 2018.
written/paper submissions): Dockets Staff, 5630 Fishers Lane, Rm. 1061,
Management Staff (HFA–305), Food and Leslie Kux,
Rockville, MD 20852. Associate Commissioner for Policy.
Drug Administration, 5630 Fishers You may submit comments on any
Lane, Rm. 1061, Rockville, MD 20852. guidance at any time (see 21 CFR
[FR Doc. 2018–10928 Filed 5–21–18; 8:45 am]
• For written/paper comments 10.115(g)(5)). BILLING CODE 4164–01–P
submitted to the Dockets Management Submit written requests for single
Staff, FDA will post your comment, as copies of this guidance to the Division
well as any attachments, except for DEPARTMENT OF HEALTH AND
of Drug Information, Center for Drug
information submitted, marked and HUMAN SERVICES
Evaluation and Research, Food and
identified, as confidential, if submitted
Drug Administration, 10001 New Food and Drug Administration
as detailed in ‘‘Instructions.’’
Hampshire Ave., Hillandale Building,
Instructions: All submissions received [Docket No. FDA–2013–D–1020]
must include the Docket No. FDA– 4th Floor, Silver Spring, MD 20993–
2005–D–0461 for ‘‘Acne Vulgaris: 0002. Send one self-addressed adhesive
Bioanalytical Method Validation;
Establishing Effectiveness of Drugs label to assist that office in processing
Guidance for Industry; Availability
Intended for Treatment; Guidance for your requests. See the SUPPLEMENTARY
INFORMATION section for electronic AGENCY: Food and Drug Administration,
Industry.’’ Received comments will be
placed in the docket and, except for access to the guidance document. HHS.
those submitted as ‘‘Confidential FOR FURTHER INFORMATION CONTACT: ACTION: Notice of availability.
Submissions,’’ publicly viewable at Strother D. Dixon, Center for Drug
https://www.regulations.gov or at the Evaluation and Research, Food and SUMMARY: The Food and Drug
Dockets Management Staff between 9 Drug Administration, 10903 New Administration (FDA or Agency) is
a.m. and 4 p.m., Monday through Hampshire Ave., Bldg. 22, Rm. 5168, announcing the availability of a final
Friday. Silver Spring, MD 20993–0002, 301– guidance for industry entitled
• Confidential Submissions—To 796–1015. ‘‘Bioanalytical Method Validation.’’
submit a comment with confidential SUPPLEMENTARY INFORMATION:
This final guidance incorporates public
information that you do not wish to be comments to the revised draft published
made publicly available, submit your I. Background in 2013 as well as the latest scientific
comments only as a written/paper FDA is announcing the availability of feedback concerning bioanalytical
submission. You should submit two a guidance for industry entitled ‘‘Acne method validation and provides the
copies total. One copy will include the Vulgaris: Establishing Effectiveness of most up-to-date information needed by
information you claim to be confidential Drugs Intended for Treatment.’’ This drug developers to ensure the
with a heading or cover note that states guidance provides recommendations to bioanalytical quality of their data.
‘‘THIS DOCUMENT CONTAINS industry for establishing the clinical DATES: The announcement of the
CONFIDENTIAL INFORMATION.’’ The effectiveness of drugs for the treatment guidance is published in the Federal
Agency will review this copy, including of acne. This guidance finalizes the draft Register on May 22, 2018.
the claimed confidential information, in guidance for industry entitled ‘‘Acne ADDRESSES: You may submit either
its consideration of comments. The Vulgaris: Developing Drugs for electronic or written comments on
second copy, which will have the Treatment,’’ issued September 19, 2005 Agency guidances at any time as
claimed confidential information (70 FR 54945). Comments on the draft follows:
redacted/blacked out, will be available guidance were considered while
for public viewing and posted on finalizing this guidance. Changes made Electronic Submissions
https://www.regulations.gov. Submit to the draft guidance include Submit electronic comments in the
both copies to the Dockets Management reformatting into a bulleted presentation following way:
Staff. If you do not wish your name and and streamlining of information to core • Federal eRulemaking Portal:
contact information to be made publicly recommendations. https://www.regulations.gov. Follow the
available, you can provide this This guidance is being issued instructions for submitting comments.
information on the cover sheet and not consistent with FDA’s good guidance Comments submitted electronically,
in the body of your comments and you practices regulation (21 CFR 10.115). including attachments, to https://
must identify this information as The guidance represents the current www.regulations.gov will be posted to
amozie on DSK3GDR082PROD with NOTICES1
‘‘confidential.’’ Any information marked thinking of FDA on establishing the the docket unchanged. Because your
as ‘‘confidential’’ will not be disclosed effectiveness of drugs intended to treat comment will be made public, you are
except in accordance with 21 CFR 10.20 acne. It does not establish any rights for solely responsible for ensuring that your
and other applicable disclosure law. For any person and is not binding on FDA comment does not include any
more information about FDA’s posting or the public. You can use an alternative confidential information that you or a
of comments to public dockets, see 80 approach if it satisfies the requirements third party may not wish to be posted,
FR 56469, September 18, 2015, or access of the applicable statutes and such as medical information, your or
VerDate Sep<11>2014 16:47 May 21, 2018 Jkt 241001 PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 E:\FR\FM\22MYN1.SGM 22MYN1](https://thefederalregister.org/doc/83_FR_23788/page/2.svg)
Document Created: 2018-11-02 11:09:41
Document Modified: 2018-11-02 11:09:41
| 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 | The announcement of the guidance is published in the Federal Register on May 22, 2018. | |
| Contact | Strother D. Dixon, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 5168, Silver Spring, MD 20993-0002, 301- 796-1015. | |
| FR Citation | 83 FR 23689 |
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