51844 Federal Register / Vol. 82, No. 215 / Wednesday, November 8, 2017 / Notices 

information technology to minimize the 

information collection burden. 

DATES: Comments must be received by 

January 8, 2018. 

ADDRESSES: When commenting, please 

reference the document identifier or 

OMB control number. To be assured 

consideration, comments and 

recommendations must be submitted in 

any one of the following ways: 

1. Electronically. You may send your 

comments electronically to http://

www.regulations.gov. Follow the 

instructions for ‘‘Comment or 

Submission’’ or ‘‘More Search Options’’ 

to find the information collection 

document(s) that are accepting 

comments. 

2. By regular mail. You may mail 

written comments to the following 

address: CMS, Office of Strategic 

Operations and Regulatory Affairs, 

Division of Regulations Development, 

Attention: Document Identifier/OMB 

Control Number __, Room C4–26–05, 

7500 Security Boulevard, Baltimore, 

Maryland 21244–1850. 

To obtain copies of a supporting 

statement and any related forms for the 

proposed collection(s) summarized in 

this notice, you may make your request 

using one of following: 

1. Access CMS’ Web site address at 

http://www.cms.hhs.gov/ 

PaperworkReductionActof1995. 

2. Email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov. 

3. Call the Reports Clearance Office at 

(410) 786–1326. 

FOR FURTHER INFORMATION CONTACT: 

William Parham at (410) 786–4669. 

SUPPLEMENTARY INFORMATION: 

Contents 

This notice sets out a summary of the 

use and burden associated with the 

following information collections. More 

detailed information can be found in 

each collection’s supporting statement 

and associated materials (see 

ADDRESSES). 

CMS–10653 Coverage of Certain 

Preventive Services Under the 

Affordable Care Act 

Under the PRA (44 U.S.C. 3501– 

3520), federal agencies must obtain 

approval from the Office of Management 

and Budget (OMB) for each collection of 

information they conduct or sponsor. 

The term ‘‘collection of information’’ is 

defined in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA 

requires federal agencies to publish a 

60-day notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension or reinstatement of an existing 

collection of information, before 

submitting the collection to OMB for 

approval. To comply with this 

requirement, CMS is publishing this 

notice. 

1. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Coverage of 

Certain Preventive Services Under the 

Affordable Care Act; Use: The 2017 

interim final regulations titled 

‘‘Religious Exemptions and 

Accommodations for Coverage of 

Certain Preventive Services Under the 

Affordable Care Act’’ and ‘‘Moral 

Exemptions and Accommodations for 

Coverage of Certain Preventive Services 

Under the Affordable Care Act’’ expand 

exemptions for religious beliefs and 

moral convictions for certain entities or 

individuals whose health plans may 

otherwise be subject to a mandate of 

contraceptive coverage through 

guidance issued pursuant to the Patient 

Protection and Affordable Care Act. The 

interim final rules extend the exemption 

to health insurance issuers that hold 

religious or moral objections in certain 

circumstances. The interim final rules 

also allow plan participants and 

enrollees with sincerely held religious 

or moral objections to request coverage 

that does not include contraceptive 

services. 

The interim final rules also leave the 

accommodation process in place as an 

optional process for objecting entities 

who wish to use it voluntarily. To avoid 

contracting, arranging, paying, or 

referring for contraceptive coverage, an 

organization seeking to be treated as an 

eligible organization may self-certify (by 

using EBSA Form 700), prior to the 

beginning of the first plan year to which 

an accommodation is to apply, that it 

meets the definition of an eligible 

organization. The eligible organization 

must provide a copy of its selfcertification to each health insurance 

issuer that would otherwise provide 

such coverage in connection with the 

health plan (for insured group health 

plans or student health insurance 

coverage). The issuer that receives the 

self-certification must provide separate 

payments for contraceptive services for 

plan participants and beneficiaries (or 

students and dependents). For a selfinsured group health plan, the selfcertification must be provided to its 

third party administrator. An eligible 

organization may alternatively submit a 

notification to HHS as an alternative to 

submitting the EBSA Form 700 to the 

eligible organization’s health insurance 

issuer or third party administrator. A 

health insurance issuer or third party 

administrator providing or arranging 

payments for contraceptive services for 

participants and beneficiaries in plans 

(or student enrollees and covered 

dependents in student health insurance 

coverage) of eligible organizations must 

provide a written notice to such plan 

participants and beneficiaries (or such 

student enrollees and covered 

dependents) informing them of the 

availability of such payments. 

Eligible organizations can revoke at 

any time the accommodation process if 

participants and beneficiaries receive 

written notice of such revocation from 

the issuer or third party administrator in 

accordance with guidance issued by the 

Secretary, and if the accommodation 

process is currently being utilized, such 

revocation will be effective on the first 

day of the first plan year that begins on 

or after thirty days after the date of 

revocation. Form Number: CMS–10653 

(OMB control number 0938–1344); 

Frequency: On Occasion; Affected 

Public: Private Sector; Number of 

Respondents: 110; Number of 

Responses: 274,629; Total Annual 

Hours: 181. (For policy questions 

regarding this collection contact Usree 

Bandyopadhyay at 410–786–6650. For 

all other issues call (410) 786–1326.) 

Dated: November 3, 2017. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2017–24305 Filed 11–7–17; 8:45 am] 

BILLING CODE 4120–01–P 

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 


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Federal Register / Vol. 82, No. 215 / Wednesday, November 8, 2017 / Notices 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.gpo.gov/ 

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/Guidance

ComplianceRegulatoryInformation/

Guidances/default.htm or https://

www.regulations.gov. 


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51846 Federal Register / Vol. 82, No. 215 / Wednesday, November 8, 2017 / Notices 

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–D–0575] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Guidance for 

Industry on Expedited Programs for 

Serious Conditions—Drugs and 

Biologics 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed revision of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on the information 

collection in the guidance for industry 

‘‘Expedited Programs for Serious 

Conditions—Drugs and Biologics.’’ 

DATES: Submit either electronic or 

written comments on the collection of 

information by January 8, 2018. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before January 8, 

2018. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of January 8, 2018. Comments 

received by mail/hand delivery/courier 

(for written/paper submissions) will be 

considered timely if they are 

postmarked or the delivery service 

acceptance receipt is on or before that 

date. 

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– 

2013–D–0575 for ‘‘Guidance for 

Industry on Expedited Programs for 

Serious Conditions—Drugs and 

Biologics.’’ Received comments, those 

filed in a timely manner (see 

ADDRESSES), 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.gpo.gov

/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. 

FOR FURTHER INFORMATION CONTACT: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, PRAStaff@fda.

hhs.gov. 

SUPPLEMENTARY INFORMATION:

Guidance for Industry on Expedited 

Programs for Serious Conditions— 

Drugs and Biologics 

OMB Control Number 0910–0765— 

Revision 

This information collection supports 

the previous captioned Agency 

guidance. The guidance provides a 

single resource for information on 

FDA’s policies and procedures related 

to the following expedited programs for 

serious conditions: (1) Fast track 

designation, (2) breakthrough therapy 

designation, (3) accelerated approval, 

and (4) priority review designation. The 

guidance describes threshold criteria 

generally applicable to expedited 

programs, including what is meant by 

serious condition, unmet medical need, 

and available therapy. The guidance 

addresses the applicability of expedited 

programs to rare diseases, clarification 

on available therapy, and additional 

detail on possible flexibility in 

manufacturing and product quality. The 

guidance also clarifies the qualifying 

criteria for breakthrough therapy 


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