Federal Register / Vol. 83, No. 139 / Thursday, July 19, 2018 / Notices 34143 

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– 

2018–D–2326 for ‘‘Field Alert Report 

Submission: Questions and Answers; 

Draft Guidance for Industry.’’ 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 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 to 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: 

Mamta Gautam-Basak, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 21, Rm. 2508, 

Silver Spring, MD 20993–0002, 301– 

796–0712; 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; or Rachel Harrington, 

Office of Regulatory Affairs, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 32, Rm. 4339, 

Silver Spring, MD 20993–0002, 410– 

779–5441. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Field Alert Report Submission: 

Questions and Answers.’’ The FAR 

regulations found in 21 CFR 

314.81(b)(1) and 314.98(b) establish an 

early warning system to help protect 

patient health. Under these regulations, 

NDA and ANDA applicants must submit 

certain information to FDA about 

distributed drug products regulated by 

the Center for Drug Evaluation and 

Research or the Center for Biologics 

Evaluation and Research. 

The draft guidance addresses the FAR 

submission requirements and focuses on 

topics such as the incidents and 

possible/actual quality issues that 

require submission of a FAR, the 

contents of the FAR, who submits the 

FAR, and when, where, and how they 

should submit it. The draft guidance 

also addresses followup and final FARs, 

which are not required under 

§ 314.81(b), and recommends their 

submission to inform FDA of the status 

of root cause investigations and 

corrective actions taken, if any. 

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 field alert report submissions. 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 

The 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 21 CFR 

part 314 have been approved under 

OMB control number 0910–0001. 

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: July 13, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–15389 Filed 7–18–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Drug Abuse; 

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., 


sradovich on DSK3GMQ082PROD with NOTICES
34144 Federal Register / Vol. 83, No. 139 / Thursday, July 19, 2018 / Notices 

as amended. The contract proposals and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the contract 

proposals, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute on 

Drug Abuse Special Emphasis Panel; NIDA 

International Research and Training Program 

Support Services (1158). 

Date: August 9, 2018. 

Time: 10:00 a.m. to 2:00 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852 (Telephone 

Conference Call). 

Contact Person: Susan O. McGuire, Ph.D., 

Scientific Review Officer, Office of 

Extramural Policy and Review, National 

Institute on Drug Abuse, National Institutes 

of Health, DHHS, 6001 Executive Blvd., 

Room 4245, Rockville, MD 20852, 301–827– 

5817, mcguireso@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program No.: 93.279, Drug Abuse and 

Addiction Research Programs, National 

Institutes of Health, HHS) 

Dated: July 13, 2018. 

Natasha M. Copeland, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2018–15358 Filed 7–18–18; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Eunice Kennedy Shriver National 

Institute of Child Health & Human 

Development; 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. The contract proposals and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the contract 

proposals, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Child Health and Human Development 

Special Emphasis Panel; Newborn Screening 

Translational Research Network (NBSTRN) 

August 13, 2018. 

Time: 1:00 p.m. to 4:00 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: National Institutes of Health, 6710 B 

Rockledge Drive, Bethesda, MD 20892 

(Telephone Conference Call). 

Contact Person: Sathasiva B. Kandasamy, 

Ph.D., Scientific Review Administrator, 

Division of Scientific Review, National 

Institute of Child Health and Human 

Development, 6710B Rockledge Drive, 

Bethesda, MD 20892, (301) 435–6680, 

skandasa@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.864, Population Research; 

93.865, Research for Mothers and Children; 

93.929, Center for Medical Rehabilitation 

Research; 93.209, Contraception and 

Infertility Loan Repayment Program, National 

Institutes of Health, HHS) 

Dated: July 13, 2018. 

Ronald J. Livingston, Jr., 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2018–15357 Filed 7–18–18; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Neurological 

Disorders and Stroke; Notice of Closed 

Meetings 

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. 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: National Institute of 

Neurological Disorders and Stroke Special 

Emphasis Panel; Planning Grant to Develop 

Phase III Clinical Trials for LBD. 

Date: August 6, 2018. 

Time: 3:00 p.m. to 4:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852 (Telephone 

Conference Call). 

Contact Person: Ana Olariu, Ph.D., 

Scientific Review Officer, Scientific Review 

Branch, NINDS/NIH/DHHS, Neuroscience 

Center, 6001 Executive Blvd., Suite 3208, 

MSC 9529, Bethesda, MD 20892–9529, (301) 

496–9223, ana.olariu@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.853, Clinical Research 

Related to Neurological Disorders; 93.854, 

Biological Basis Research in the 

Neurosciences, National Institutes of Health, 

HHS) 

Dated: July 13, 2018. 

Natasha M. Copeland, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2018–15359 Filed 7–18–18; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Center for Substance Abuse 

Prevention; Notice of Meeting 

Pursuant to Public Law 92–463, 

notice is hereby given for the meeting of 

the Substance Abuse and Mental Health 

Services Administration’s (SAMHSA) 

Center for Substance Abuse Prevention 

National Advisory Council (CSAP NAC) 

on August 1, 2018. 

The Council was established to advise 

the Secretary, Department of Health and 

Human Services (HHS); the Assistant 

Secretary for Mental Health and 

Substance Use, SAMHSA; and Director, 

CSAP concerning matters relating to the 

activities carried out by and through the 

Center and the policies respecting such 

activities. 

The meeting will be open to the 

public and will include the discussion 

of the substance use prevention 

workforce and opioid use prevention. 

The meeting will also include updates 

on CSAP program developments. 

The meeting will be held in Rockville, 

Maryland. Attendance by the public 

will be limited to the space available. 

Interested persons may present data, 

information, or views, orally or in 

writing, on issues pending before the 

Council. Written submissions should be 

forwarded to the contact person on or 

before one week prior to the meeting. 

Oral presentations from the public will 

be scheduled at the conclusion of the 

meeting. Individuals interested in 

making oral presentations should notify 

the contact on or before one week prior 

to the meeting. Five minutes maximum 

will be allotted for each presentation. 

To attend onsite, submit written or 

brief oral comments, or request special 

accommodations for persons with 

disabilities, please register at the 

SAMHSA Committees’ website, http://

nac.samhsa.gov/Registration/ 


sradovich on DSK3GMQ082PROD with NOTICES