Federal Register / Vol. 83, No. 171 / Tuesday, September 4, 2018 / Notices 44883 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Notice of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended, and the Determination of 

the Director, Management Analysis and 

Services Office, CDC, pursuant to Public 

Law 92–463. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Disease, 

Disability, and Injury Prevention and 

Control Special Emphasis Panel (SEP)— 

PAR 13–129, NIOSH Member Conflict 

Special Emphasis Panel. 

Date: October 25, 2018. 

Time: 1:00 p.m.–5:00 p.m. EST. 

Place: Teleconference. 

Agenda: To review and evaluate grant 

applications. 

For Further Information Contact: Nina 

Turner, Ph.D., Scientific Review Officer, 

Office of Extramural Programs, 1095 

Willowdale Road, Morgantown, WV 

26506, (304) 285–5976; nxt2@cdc.gov. 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

management activities, for both the 

Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Sherri Berger, 

Chief Operating Officer, Centers for Disease 

Control and Prevention. 

[FR Doc. 2018–19077 Filed 8–31–18; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2016–D–3969] 

Physiologically Based 

Pharmacokinetic Analyses—Format 

and Content; 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 final 

guidance for industry entitled 

‘‘Physiologically Based Pharmacokinetic 

Analyses—Format and Content.’’ This 

guidance outlines the recommended 

format and content for a sponsor or 

applicant to submit physiologically 

based pharmacokinetic (PBPK) analyses 

to FDA to support applications 

including, but not limited to, 

investigational new drug applications 

(INDs), new drug applications (NDAs), 

biologics license applications (BLAs), or 

abbreviated new drug applications 

(ANDAs). This guidance does not 

address methodological considerations 

and best practices for the conduct of 

PBPK modeling and simulation or the 

appropriateness of PBPK analyses for a 

particular drug or a drug product. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on September 4, 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. 

• 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–3969 for ‘‘Physiologically 

Based Pharmacokinetic Analyses— 

Format and Content.’’ 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/ 


sradovich on DSK3GMQ082PROD with NOTICES
44884 Federal Register / Vol. 83, No. 171 / Tuesday, September 4, 2018 / Notices 

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: 

Xinyuan Zhang, Office of Clinical 

Pharmacology, Office of Translational 

Sciences, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 2128, Silver Spring, 

MD 20993–0002, 240–402–7971. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a final guidance for industry entitled 

‘‘Physiologically Based Pharmacokinetic 

Analyses—Format and Content.’’ A 

PBPK analysis uses models and 

simulations that combine physiology, 

population, and drug characteristics to 

mechanistically describe the 

pharmacokinetic behaviors of a drug or 

drug product. Throughout a drug’s life 

cycle, PBPK model predictions can be 

used to support decisions on whether, 

when, and how to conduct certain 

clinical pharmacology studies, and to 

support dosing recommendations in 

product labeling. Because of the lack of 

regulatory guidance, the format and 

content of PBPK analysis reports that 

are submitted to FDA vary significantly. 

The goal of this guidance is to 

standardize the content and format of 

these reports to facilitate FDA’s efficient 

assessment, consistent application, and 

timely decision making during 

regulatory review. 

This guidance outlines the 

recommended format and content for a 

sponsor or applicant to submit PBPK 

analyses to FDA to support applications 

including, but not limited to, INDs, 

NDAs, BLAs, and ANDAs. This 

guidance does not address 

methodological considerations and best 

practices for the conduct of PBPK 

modeling and simulation or the 

appropriateness of PBPK analyses for a 

particular drug or a drug product. 

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 ‘‘Physiologically 

Based Pharmacokinetic Analyses— 

Format and Content.’’ 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 

found in FDA regulations. These 

collections of information 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 collection of information in 

21 CFR 314.50(d) has been approved 

under OMB control number 0910–0001. 

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. 

Dated: August 27, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–19065 Filed 8–31–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1048] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Medical Device 

Labeling Regulations 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by October 4, 

2018. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, Fax: 202– 

395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0485. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Amber Sanford, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–8867, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Medical Device Labeling Regulations— 

21 CFR Parts 800, 801, and 809 

OMB Control Number 0910–0485— 

Extension 

Section 502 of the Federal Food, Drug, 

and Cosmetic Act (FD&C Act) (21 U.S.C. 

352), among other things, establishes 

requirements for the label or labeling of 

a medical device so that it is not 

misbranded and subject to a regulatory 

action. Certain provisions under section 

502 of the FD&C Act require 

manufacturers, importers, and 

distributors of medical devices to 

disclose information about themselves 

or the devices on the labels or labeling 

for the devices. 

Section 502(b) of the FD&C Act 

requires that for packaged devices, the 

label must bear the name and place of 

business of the manufacturer, packer, or 

distributor; and an accurate statement of 

the quantity of the contents. Section 

502(f) of the FD&C Act requires that the 

labeling for a device must contain 

adequate directions for use. FDA may, 

however, grant an exemption if the 

Agency determines that the adequate 

directions for use labeling requirements 

are not necessary for the particular case 

as it relates to protection of the public 

health. 

FDA regulations under parts 800, 801, 

and 809 (21 CFR parts 800, 801, and 

809) require disclosure of specific 


sradovich on DSK3GMQ082PROD with NOTICES