Federal Register / Vol. 83, No. 13 / Friday, January 19, 2018 / Notices 2797 

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copies of the draft guidance to the 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, or the Office of Communication, 

Outreach, and Development, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

3128, 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access to the draft guidance document.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: 

Debra Beitzell, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Rm 6460, 

Silver Spring, MD 20993–0002, 301– 

796–0700; or Stephen Ripley, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

7301, Silver Spring, MD 20993–0002, 

240–402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Product Title and Initial U.S. Approval 

in the Highlights of Prescribing 

Information for Human Prescription 

Drug and Biological Products—Content 

and Format.’’ 

On January 24, 2006, FDA published 

a final rule amending the requirements 

for the content and format of labeling for 

human prescription drug and biological 

products (71 FR 3922, January 24, 2006). 

This rule is known as the physician 

labeling rule because it addresses 

prescription drug labeling that is used 

by physicians and other health care 

providers. Under this rule, the 

prescribing information of new and 

more recently approved prescription 

drug and biological products contains 

the following three sections: Highlights, 

Full Prescribing Information: Contents, 

and Full Prescribing Information 

(§ 201.56(d)(1) (21 CFR 201.56(d)(1))). 

Highlights is required to contain the 

drug names (proprietary name and 

nonproprietary name (established name 

of the drug or, for biological products, 

the proper name)), dosage form, route of 

administration, and, if applicable, 

controlled substance symbol of the drug 

or biological product (§ 201.57(a)(2) (21 

CFR 201.57(a)(2))). This set of 

information is referred to as the 

‘‘product title’’ and follows the 

Highlights Limitation Statement. 

Highlights also must include the year of 

initial U.S. approval of the drug or 

biological product (§ 201.57(a)(3)). The 

initial U.S. approval must be placed 

immediately beneath the product title 

and is the four-digit year in which FDA 

initially approved the new molecular 

entity, new biological product, or new 

combination of active ingredients. 

This draft guidance provides 

recommendations on the content and 

format of the product title in Highlights. 

Recommended sources for product title 

terminology also are provided. 

Appendix A, ‘‘Dosage Form Terms for 

Use in Human Drug Product Labeling’’ 

and Appendix B, ‘‘Route of 

Administration Terms for Use in Human 

Drug Product Labeling’’ contain lists of 

recommended dosage form and route of 

administration terms, respectively, for 

use in the product title. This draft 

guidance contains recommendations for 

products with special nomenclature 

considerations, recommendations for 

what not to include in the product title, 

and implications for container and 

carton labeling. 

The draft guidance also provides 

recommendations on the content and 

format of the initial U.S. approval in 

Highlights. Items to consider when 

determining the year of initial U.S. 

approval are included and drug 

products requiring special consideration 

are described. 

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 the content and format of the product 

title and initial U.S. approval in 

Highlights for human prescription drug 

and biological products. 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. The Paperwork Reduction Act of 

1995 

This draft 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 §§ 201.56 

and 201.57 have been approved under 

OMB control number 0910–0572. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at https:// 

www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm, https:// 

www.fda.gov/BiologicsBloodVaccines/ 

GuidanceComplianceRegulatory

Information/default.htm, or https:// 

www.regulations.gov. 

Dated: January 12, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–00899 Filed 1–18–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–D–6880] 

Material Threat Medical 

Countermeasure Priority Review 

Vouchers; Draft Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a draft 

guidance for industry entitled ‘‘Material 

Threat Medical Countermeasure Priority 

Review Vouchers.’’ There is stakeholder 

interest in FDA’s implementation of the 

provision of the 21st Century Cures Act 

(Cures Act) that adds a new section to 

the Federal Food, Drug, and Cosmetic 

Act (FD&C Act) on priority review 

vouchers for material threat medical 

countermeasure applications. This new 

section of the FD&C Act makes 

provisions for awarding priority review 

vouchers for use with applications to 

sponsors of material threat medical 

countermeasure applications that meet 

the criteria specified by the FD&C Act. 


daltland on DSKBBV9HB2PROD with NOTICES
2798 Federal Register / Vol. 83, No. 13 / Friday, January 19, 2018 / Notices 

This draft guidance explains to internal 

and external stakeholders how FDA 

intends to implement the provisions of 

the new section of the FD&C Act. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by March 20, 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– 

2017–D–6880 for ‘‘Material Threat 

Medical Countermeasure Priority 

Review Vouchers; Draft 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 office of 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 the guidance to Office of 

Counterterrorism and Emerging Threats, 

Office of the Commissioner, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 1, Rm. 4343, 

Silver Spring, MD 20993–0002, 301– 

796–8510. 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: 

Carol Drew, Office of Counterterrorism 

and Emerging Threats, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 1, Rm. 4320, Silver Spring, 

MD 20993–0002, 301–796–8510 (this is 

not a toll free number). 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled, 

‘‘Material Threat Medical 

Countermeasure Priority Review 

Vouchers.’’ Section 3086 of the Cures 

Act adds new section 565A to the FD&C 

Act. Section 565A of the FD&C Act (21 

U.S.C. 360bbb–4a) was designed to 

encourage development of medical 

countermeasures by offering additional 

incentives for obtaining approval of new 

drug or biological medical products for 

the prevention and treatment of harm 

from a biological, chemical, 

radiological, or nuclear agent identified 

as a material threat. Under section 565A 

of the FD&C Act, a sponsor of a human 

drug application for a material threat 

medical countermeasure application 

may be eligible for a voucher that can 

be used to obtain a priority review for 

any application submitted under section 

505(b)(1) of the FD&C Act (21 U.S.C. 

355(b)(1)) or section 351 of the Public 

Health Service (PHS) Act (42 U.S.C. 

262). The draft guidance also provides 

information on using the priority review 

vouchers and on transferring priority 

review vouchers to other sponsors. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance represents the 

current thinking of FDA on obtaining a 

material threat medical countermeasure 

priority review voucher. It does not 

create or confer any rights for or on any 

person and does not operate to bind 

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 

Under the Paperwork Reduction Act 

of 1995 (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 that they conduct or 

sponsor. ‘‘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, 44 

U.S.C. 3506(c)(2)(A), requires Federal 


daltland on DSKBBV9HB2PROD with NOTICES
Federal Register / Vol. 83, No. 13 / Friday, January 19, 2018 / Notices 2799 

agencies to provide a 60-day notice in 

the Federal Register for each proposed 

collection of information before 

submitting the collection to OMB for 

approval. To comply with this 

requirement, FDA is publishing this 

notice of the proposed collection of 

information set forth in this document. 

With respect to the collection of 

information associated with this draft 

guidance, FDA invites comment on the 

following topics: (1) Whether the 

proposed information collected is 

necessary for the proper performance of 

FDA’s functions, including whether the 

information will have practical utility; 

(2) the accuracy of FDA’s estimated 

burden of the proposed information 

collected, including the validity of the 

methodology and assumptions used; (3) 

ways to enhance the quality, utility, and 

clarity of the information collected; and 

(4) ways to minimize the burden of 

information collected on the 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Under the draft guidance, sponsors of 

certain medical countermeasure product 

applications submitted under section 

505(b)(1) of the FD&C Act and section 

351 of the PHS Act may request a 

priority review voucher. Based on 

inquiries FDA has received on section 

565A and related discussions with 

sponsors, we estimate that we will 

receive annually approximately 2 

requests from 2 sponsors, and that each 

request will take approximately 8 hours 

to prepare and submit to FDA. 

The draft guidance also states that 

sponsors should notify FDA of their 

intent to use a priority review voucher, 

including the date on which the sponsor 

intends to submit the application, at 

least 90 days before use. We estimate 

that we will receive annually 

approximately 2 notifications of intent 

to use a voucher from 2 sponsors, and 

that each notification will take 

approximately 8 hours to prepare and 

submit to FDA. The draft guidance also 

permits the transfer of a priority review 

voucher from one sponsor to another, 

and states that each transfer should be 

documented with a letter of transfer. We 

estimate that we will receive 

approximately 1 letter indicating the 

transfer of a voucher from 1.5 

application holders, and 1 letter 

acknowledging the receipt of a 

transferred voucher from 1.5 new 

voucher owners acknowledging the 

transfer, and that it will take 

approximately 8 hours to prepare and 

submit each letter to FDA. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Reporting under Section 3086 of the Cures Act Number of respondents 

Number of 

responses per 

respondent 

Total 

responses 

Hours per 

response 

Total 

hours 

Priority review voucher request ........................................... 2 1 2 8 16 

Notifications of intent to use a voucher ............................... 2 1 2 8 16 

Letters indicating the transfer of a voucher ......................... 1.5 1 1.5 8 12 

Letters acknowledging the receipt of a transferred voucher 1.5 1 1.5 8 12 

Total .............................................................................. ........................ ........................ ........................ ........................ 56 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at https:// 

www.fda.gov/RegulatoryInformation/ 

Guidances/default.htm, https://

www.regulations.gov, or https://

www.fda.gov/medicalcountermeasures. 

Dated: January 11, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–00900 Filed 1–17–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission to OMB for 

Review and Approval; Public Comment 

Request; Information Collection 

Request Title: National Practitioner 

Data Bank for Adverse Information on 

Physicians and Other Health Care 

Practitioners—OMB No. 0915–0126— 

Revision 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In compliance with the 

Paperwork Reduction Act of 1995, 

HRSA has submitted an Information 

Collection Request (ICR) to the Office of 

Management and Budget (OMB) for 

review and approval. Comments 

submitted during the first public review 

of this ICR will be provided to OMB. 

OMB will accept further comments from 

the public during the review and 

approval period. 

DATES: Comments on this ICR should be 

received no later than February 20, 

2018. 

ADDRESSES: Submit your comments, 

including the ICR Title, to the desk 

officer for HRSA, either by email to 

OIRA_submission@omb.eop.gov or by 

fax to 202–395–5806. 

FOR FURTHER INFORMATION CONTACT: To 

request a copy of the clearance requests 

submitted to OMB for review, email Lisa 

Wright-Solomon, the HRSA Information 

Collection Clearance Officer, at 

paperwork@hrsa.gov or call (301) 443– 

1984. 

SUPPLEMENTARY INFORMATION: When 

submitting comments or requesting 

information, please include the 

information request collection title for 

reference, in compliance with Section 

3506(c)(2)(A) of the Paperwork 

Reduction Act of 1995. 

Information Collection Request Title: 

National Practitioner Data Bank for 

Adverse Information on Physicians and 

Other Health Care Practitioners—45 

CFR part 60 Regulations and Forms, 

OMB No. 0915–0126—Revision. 


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