82 FR 51844 - Recurrent Herpes Labialis: Developing Drugs for Treatment and Prevention; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 215 (November 8, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 215 (November 8, 2017)
| Page Range | 51844-51846 | |
| FR Document | 2017-24308 |
[Federal Register Volume 82, Number 215 (Wednesday, November 8, 2017)] [Notices] [Pages 51844-51846] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-24308] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-D-1504] Recurrent Herpes Labialis: Developing Drugs for Treatment and Prevention; 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 ``Recurrent Herpes Labialis: Developing Drugs for Treatment and Prevention.'' The purpose of this guidance is to assist sponsors in all phases of development of treatments for recurrent herpes [[Page 51845]] labialis (RHL). The guidance also addresses prevention of RHL. The guidance outlines the types of nonclinical studies and clinical trials recommended throughout the drug development process to support approval of antiviral drug products for the treatment or prevention of RHL. This guidance finalizes the draft guidance of the same name issued on July 1, 2016. DATES: The announcement of the guidance is published in the Federal Register on November 8, 2017. 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. 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-1504 for ``Recurrent Herpes Labialis: Developing Drugs for Treatment and Prevention; Guidance for Industry; Availability.'' 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: Regina Alivisatos, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6340, Silver Spring, MD 20993-0002, 301- 796-1500. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled ``Recurrent Herpes Labialis: Developing Drugs for Treatment and Prevention.'' This guidance addresses nonclinical development, early phases of clinical development, phase 3 trial considerations, and safety considerations in the development of antiviral drug products used to treat or prevent RHL lesions. This guidance finalizes the draft guidance of the same name issued on July 1, 2016 (81 FR 43210). No substantive comments were received during the comment period. In addition to editorial and stylistic changes made in the guidance primarily for clarification, the requirement for a toxicity adverse event scale was omitted. 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 ``Recurrent Herpes Labialis: Developing Drugs for Treatment and Prevention.'' 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 guidance refers to previously approved collections of information that 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 part 312 have been approved under OMB control number 0910-0014. 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. [[Page 51846]] Dated: November 3, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-24308 Filed 11-7-17; 8:45 am] BILLING CODE 4164-01-P
![51844 Federal Register / Vol. 82, No. 215 / Wednesday, November 8, 2017 / Notices
information technology to minimize the Section 3506(c)(2)(A) of the PRA notification to HHS as an alternative to
information collection burden. requires federal agencies to publish a submitting the EBSA Form 700 to the
DATES: Comments must be received by 60-day notice in the Federal Register eligible organization’s health insurance
January 8, 2018. concerning each proposed collection of issuer or third party administrator. A
ADDRESSES: When commenting, please information, including each proposed health insurance issuer or third party
reference the document identifier or extension or reinstatement of an existing administrator providing or arranging
OMB control number. To be assured collection of information, before payments for contraceptive services for
consideration, comments and submitting the collection to OMB for participants and beneficiaries in plans
recommendations must be submitted in approval. To comply with this (or student enrollees and covered
any one of the following ways: requirement, CMS is publishing this dependents in student health insurance
1. Electronically. You may send your notice. coverage) of eligible organizations must
1. Type of Information Collection provide a written notice to such plan
comments electronically to http://
Request: Extension of a currently participants and beneficiaries (or such
www.regulations.gov. Follow the
approved collection; Title of student enrollees and covered
instructions for ‘‘Comment or
Information Collection: Coverage of dependents) informing them of the
Submission’’ or ‘‘More Search Options’’
Certain Preventive Services Under the availability of such payments.
to find the information collection
Affordable Care Act; Use: The 2017 Eligible organizations can revoke at
document(s) that are accepting
interim final regulations titled any time the accommodation process if
comments.
‘‘Religious Exemptions and participants and beneficiaries receive
2. By regular mail. You may mail
Accommodations for Coverage of written notice of such revocation from
written comments to the following
Certain Preventive Services Under the the issuer or third party administrator in
address: CMS, Office of Strategic
Affordable Care Act’’ and ‘‘Moral accordance with guidance issued by the
Operations and Regulatory Affairs,
Exemptions and Accommodations for Secretary, and if the accommodation
Division of Regulations Development,
Coverage of Certain Preventive Services process is currently being utilized, such
Attention: Document Identifier/OMB Under the Affordable Care Act’’ expand revocation will be effective on the first
Control Number __, Room C4–26–05, exemptions for religious beliefs and day of the first plan year that begins on
7500 Security Boulevard, Baltimore, moral convictions for certain entities or or after thirty days after the date of
Maryland 21244–1850. individuals whose health plans may revocation. Form Number: CMS–10653
To obtain copies of a supporting otherwise be subject to a mandate of (OMB control number 0938–1344);
statement and any related forms for the contraceptive coverage through Frequency: On Occasion; Affected
proposed collection(s) summarized in guidance issued pursuant to the Patient Public: Private Sector; Number of
this notice, you may make your request Protection and Affordable Care Act. The Respondents: 110; Number of
using one of following: interim final rules extend the exemption Responses: 274,629; Total Annual
1. Access CMS’ Web site address at to health insurance issuers that hold Hours: 181. (For policy questions
http://www.cms.hhs.gov/ religious or moral objections in certain regarding this collection contact Usree
PaperworkReductionActof1995. circumstances. The interim final rules Bandyopadhyay at 410–786–6650. For
2. Email your request, including your also allow plan participants and all other issues call (410) 786–1326.)
address, phone number, OMB number, enrollees with sincerely held religious
and CMS document identifier, to Dated: November 3, 2017.
or moral objections to request coverage
Paperwork@cms.hhs.gov. William N. Parham, III,
that does not include contraceptive
3. Call the Reports Clearance Office at services. Director, Paperwork Reduction Staff, Office
(410) 786–1326. of Strategic Operations and Regulatory
The interim final rules also leave the
FOR FURTHER INFORMATION CONTACT: Affairs.
accommodation process in place as an
William Parham at (410) 786–4669. [FR Doc. 2017–24305 Filed 11–7–17; 8:45 am]
optional process for objecting entities
who wish to use it voluntarily. To avoid BILLING CODE 4120–01–P
SUPPLEMENTARY INFORMATION:
contracting, arranging, paying, or
Contents referring for contraceptive coverage, an
This notice sets out a summary of the DEPARTMENT OF HEALTH AND
organization seeking to be treated as an
use and burden associated with the eligible organization may self-certify (by HUMAN SERVICES
following information collections. More using EBSA Form 700), prior to the Food and Drug Administration
detailed information can be found in beginning of the first plan year to which
each collection’s supporting statement an accommodation is to apply, that it [Docket No. FDA–2016–D–1504]
and associated materials (see meets the definition of an eligible
ADDRESSES). organization. The eligible organization Recurrent Herpes Labialis: Developing
must provide a copy of its self- Drugs for Treatment and Prevention;
CMS–10653 Coverage of Certain Guidance for Industry; Availability
certification to each health insurance
Preventive Services Under the
issuer that would otherwise provide AGENCY: Food and Drug Administration,
Affordable Care Act
such coverage in connection with the HHS.
Under the PRA (44 U.S.C. 3501– health plan (for insured group health ACTION: Notice of availability.
3520), federal agencies must obtain plans or student health insurance
approval from the Office of Management coverage). The issuer that receives the SUMMARY: The Food and Drug
and Budget (OMB) for each collection of self-certification must provide separate Administration (FDA or Agency) is
ethrower on DSK3G9T082PROD with NOTICES
information they conduct or sponsor. payments for contraceptive services for announcing the availability of a
The term ‘‘collection of information’’ is plan participants and beneficiaries (or guidance for industry entitled
defined in 44 U.S.C. 3502(3) and 5 CFR students and dependents). For a self- ‘‘Recurrent Herpes Labialis: Developing
1320.3(c) and includes agency requests insured group health plan, the self- Drugs for Treatment and Prevention.’’
or requirements that members of the certification must be provided to its The purpose of this guidance is to assist
public submit reports, keep records, or third party administrator. An eligible sponsors in all phases of development
provide information to a third party. organization may alternatively submit a of treatments for recurrent herpes
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![51846 Federal Register / Vol. 82, No. 215 / Wednesday, November 8, 2017 / Notices
Dated: November 3, 2017. including attachments, to https:// claimed confidential information
Anna K. Abram, www.regulations.gov will be posted to redacted/blacked out, will be available
Deputy Commissioner for Policy, Planning, the docket unchanged. Because your for public viewing and posted on
Legislation, and Analysis. comment will be made public, you are https://www.regulations.gov. Submit
[FR Doc. 2017–24308 Filed 11–7–17; 8:45 am] solely responsible for ensuring that your both copies to the Dockets Management
BILLING CODE 4164–01–P comment does not include any Staff. If you do not wish your name and
confidential information that you or a contact information to be made publicly
third party may not wish to be posted, available, you can provide this
DEPARTMENT OF HEALTH AND such as medical information, your or information on the cover sheet and not
HUMAN SERVICES anyone else’s Social Security number, or in the body of your comments and you
confidential business information, such must identify this information as
Food and Drug Administration as a manufacturing process. Please note ‘‘confidential.’’ Any information marked
[Docket No. FDA–2013–D–0575] that if you include your name, contact as ‘‘confidential’’ will not be disclosed
information, or other information that except in accordance with 21 CFR 10.20
Agency Information Collection identifies you in the body of your and other applicable disclosure law. For
Activities; Proposed Collection; comments, that information will be more information about FDA’s posting
Comment Request; Guidance for posted on https://www.regulations.gov. of comments to public dockets, see 80
Industry on Expedited Programs for • If you want to submit a comment FR 56469, September 18, 2015, or access
Serious Conditions—Drugs and with confidential information that you the information at: https://www.gpo.gov
Biologics do not wish to be made available to the /fdsys/pkg/FR-2015-09-18/pdf/2015-
public, submit the comment as a 23389.pdf.
AGENCY: Food and Drug Administration, written/paper submission and in the Docket: For access to the docket to
HHS. manner detailed (see ‘‘Written/Paper read background documents or the
ACTION: Notice. Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments
received, go to https://
SUMMARY: The Food and Drug Written/Paper Submissions
www.regulations.gov and insert the
Administration (FDA or Agency) is Submit written/paper submissions as docket number, found in brackets in the
announcing an opportunity for public follows: heading of this document, into the
comment on the proposed collection of • Mail/Hand delivery/Courier (for ‘‘Search’’ box and follow the prompts
certain information by the Agency. written/paper submissions): Dockets and/or go to the Dockets Management
Under the Paperwork Reduction Act of Management Staff (HFA–305), Food and Staff, 5630 Fishers Lane, Rm. 1061,
1995 (PRA), Federal Agencies are Drug Administration, 5630 Fishers Rockville, MD 20852.
required to publish notice in the Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT:
Federal Register concerning each • For written/paper comments Domini Bean, Office of Operations,
proposed collection of information, submitted to the Dockets Management Food and Drug Administration, Three
including each proposed revision of an Staff, FDA will post your comment, as White Flint North, 10A–12M, 11601
existing collection of information, and well as any attachments, except for Landsdown St., North Bethesda, MD
to allow 60 days for public comment in information submitted, marked and 20852, 301–796–5733, PRAStaff@fda.
response to the notice. This notice identified, as confidential, if submitted hhs.gov.
solicits comments on the information as detailed in ‘‘Instructions.’’
collection in the guidance for industry Instructions: All submissions received SUPPLEMENTARY INFORMATION:
‘‘Expedited Programs for Serious must include the Docket No. FDA– Guidance for Industry on Expedited
Conditions—Drugs and Biologics.’’ 2013–D–0575 for ‘‘Guidance for Programs for Serious Conditions—
DATES: Submit either electronic or Industry on Expedited Programs for Drugs and Biologics
written comments on the collection of Serious Conditions—Drugs and
Biologics.’’ Received comments, those OMB Control Number 0910–0765—
information by January 8, 2018.
filed in a timely manner (see Revision
ADDRESSES: You may submit comments
as follows. Please note that late, ADDRESSES), will be placed in the docket This information collection supports
untimely filed comments will not be and, except for those submitted as the previous captioned Agency
considered. Electronic comments must ‘‘Confidential Submissions,’’ publicly guidance. The guidance provides a
be submitted on or before January 8, viewable at https://www.regulations.gov single resource for information on
2018. The https://www.regulations.gov or at the Dockets Management Staff FDA’s policies and procedures related
electronic filing system will accept between 9 a.m. and 4 p.m., Monday to the following expedited programs for
comments until midnight Eastern Time through Friday. serious conditions: (1) Fast track
at the end of January 8, 2018. Comments • Confidential Submissions—To designation, (2) breakthrough therapy
received by mail/hand delivery/courier submit a comment with confidential designation, (3) accelerated approval,
(for written/paper submissions) will be information that you do not wish to be and (4) priority review designation. The
considered timely if they are made publicly available, submit your guidance describes threshold criteria
postmarked or the delivery service comments only as a written/paper generally applicable to expedited
acceptance receipt is on or before that submission. You should submit two programs, including what is meant by
date. copies total. One copy will include the serious condition, unmet medical need,
information you claim to be confidential and available therapy. The guidance
ethrower on DSK3G9T082PROD with NOTICES
Electronic Submissions with a heading or cover note that states addresses the applicability of expedited
Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS programs to rare diseases, clarification
following way: CONFIDENTIAL INFORMATION.’’ The on available therapy, and additional
• Federal eRulemaking Portal: Agency will review this copy, including detail on possible flexibility in
https://www.regulations.gov. Follow the the claimed confidential information, in manufacturing and product quality. The
instructions for submitting comments. its consideration of comments. The guidance also clarifies the qualifying
Comments submitted electronically, second copy, which will have the criteria for breakthrough therapy
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Document Created: 2017-11-08 01:20:41
Document Modified: 2017-11-08 01:20:41
| 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 November 8, 2017. | |
| Contact | Regina Alivisatos, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6340, Silver Spring, MD 20993-0002, 301- 796-1500. | |
| FR Citation | 82 FR 51844 |
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