2796 Federal Register / Vol. 83, No. 13 / Friday, January 19, 2018 / Notices 

appropriate advisory committee meeting 

link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before March 7, 2018. Oral 

presentations from the public will be 

scheduled between approximately 12:40 

p.m. and 1:40 p.m. Those individuals 

interested in making formal oral 

presentations should notify the contact 

person and submit a brief statement of 

the general nature of the evidence or 

arguments they wish to present, the 

names and addresses of proposed 

participants, and an indication of the 

approximate time requested to make 

their presentation on or before February 

13, 2018. Time allotted for each 

presentation may be limited. If the 

number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by February 14, 2018. 

Persons attending FDA’s advisory 

committee meetings are advised that 

FDA is not responsible for providing 

access to electrical outlets. 

For press inquiries, please contact the 

Office of Media Affairs at fdaoma@

fda.hhs.gov or 301–796–4540. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with disabilities. 

If you require accommodations due to a 

disability, please contact Jay R. 

Fajiculay (See, FOR FURTHER

INFORMATION CONTACT) at least 7 days in 

advance of the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our website at 

https://www.fda.gov/ 

AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: January 10, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–00903 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–6969] 

Product Title and Initial U.S. Approval 

in Highlights for Human Prescription 

Drug and Biological Products— 

Content and Format; Draft 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 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.’’ The 

labeling regulations for human drug and 

biological products require that the 

Highlights of Prescribing Information 

(Highlights) contain a product title and 

the year of initial U.S. approval. This 

draft guidance provides 

recommendations on the content and 

format of the product title and initial 

U.S. approval to bring greater 

consistency to the presentation of these 

required elements and to help ensure 

these elements provide clear and useful 

information to the health care provider. 

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–6969 for ‘‘Product Title and 

Initial U.S. Approval in Highlights for 

Human Prescription Drug and Biological 

Products—Content and Format; 

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 


daltland on DSKBBV9HB2PROD with NOTICES
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