amozie on DSK9F9SC42PROD with NOTICES

Federal Register / Vol. 84, No. 51 / Friday, March 15, 2019 / Notices 

• 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– 

2012–D–1145 for ‘‘Enrichment 

Strategies for Clinical Trials to Support 

Demonstration of Effectiveness of 

Human Drugs and Biological Products; 

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; 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 guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Robert Temple, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Rm. 4212, 

Silver Spring, MD 20993–0002, 301– 

796–2270; 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 final guidance for industry entitled 

‘‘Enrichment Strategies for Clinical 

Trials to Support Demonstration of 

Effectiveness of Human Drugs and 

Biological Products.’’ This document 

provides guidance to industry on 

enrichment strategies that can be used 

in clinical trials intended to 

demonstrate effectiveness (and in some 

cases safety) of human drugs and 

biological products. This guidance 

finalizes the draft guidance entitled 

‘‘Enrichment Strategies for Clinical 

Trials to Support Approval of Human 

Drugs and Biological Products’’ issued 

on December 17, 2012 (77 FR 74670). 

Changes made to the guidance took into 

consideration comments received 

related to discussions of study design 

and analysis, specific patient 

populations to be studied, and genomic 

strategy considerations. In addition, 

editorial changes were made, primarily, 

for clarification and elimination of 

redundancies. Although the draft 

guidance was issued by the Center for 

Drug Evaluation and Research (CDER), 

the Center for Biologics Evaluation and 

Research (CBER), and the Center for 

Devices and Radiological Health, upon 

consideration, the finalized guidance is 

being issued by CDER and CBER only 

because the topics covered pertain 

mostly to studies conducted for 

products regulated by these two centers. 

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 ‘‘Enrichment 

Strategies for Clinical Trials to Support 

Demonstration of Effectiveness of 

Human Drugs 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. Paperwork Reduction Act

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 parts 312 and 

314 have been approved under OMB 

control numbers 0910–0014 and 0910– 

0001, respectively, and the collection of 

information resulting from prescription 

drug product labeling is approved under 

OMB control number 0910–0572. 

III. Electronic Access

Persons with access to the internet

may obtain the 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: March 11, 2019. 

Lowell J. Schiller, 

Acting Associate Commissioner for Policy. 

[FR Doc. 2019–04815 Filed 3–14–19; 8:45 am] 

BILLING CODE 4164–01–P 

9535 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Designation of a Class of Employees 

for Addition to the Special Exposure 

Cohort 

AGENCY: National Institute for 

Occupational Safety and Health 

(NIOSH), Centers for Disease Control 

and Prevention, Department of Health 

and Human Services (HHS). 

amozie on DSK9F9SC42PROD with NOTICES

9536 Federal Register / Vol. 84, No. 51 / Friday, March 15, 2019 / Notices 

ACTION: Notice. 

SUMMARY: HHS gives notice of a 

decision to designate a class of 

employees from the Y–12 Plant in Oak 

Ridge, Tennessee, as an addition to the 

Special Exposure Cohort (SEC) under 

the Energy Employees Occupational 

Illness Compensation Program Act of 

2000. 

FOR FURTHER INFORMATION CONTACT: 

Stuart L. Hinnefeld, Director, Division 

of Compensation Analysis and Support, 

NIOSH, 1090 Tusculum Avenue, MS C– 

46, Cincinnati, OH 45226–1938, 

Telephone 1–877–222–7570. 

Information requests can also be 

submitted by email to DCAS@CDC.GOV. 

SUPPLEMENTARY INFORMATION: 

Authority: 42 U.S.C. 7384q(b). 42 U.S.C. 

7384l(14)(C). 

On February 26, 2019, as provided for 

under 42 U.S.C. 7384l(14)(C), the 

Secretary of HHS designated the 

following class of employees as an 

addition to the SEC: 

All employees of the Department of 

Energy, its predecessor agencies, and their 

contractors and subcontractors who worked 

at the Y–12 Plant in Oak Ridge, Tennessee, 

during the period January 1, 1958, through 

December 31, 1976, for a number of work 

days aggregating at least 250 work days, 

occurring either solely under this 

employment or in combination with work 

days within the parameters established for 

one or more other classes of employees in the 

Special Exposure Cohort. 

This designation will become 

effective on March 28, 2019, unless 

Congress provides otherwise prior to the 

effective date. After this effective date, 

HHS will publish a notice in the 

Federal Register reporting the addition 

of this class to the SEC or the result of 

any provision by Congress regarding the 

decision by HHS to add the class to the 

SEC. 

Frank J. Hearl, 

Chief of Staff, National Institute for 

Occupational Safety and Health. 

[FR Doc. 2019–04824 Filed 3–14–19; 8:45 am] 

BILLING CODE 4163–19–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Arthritis and 

Musculoskeletal and Skin Diseases; 

Amended Notice of Meeting 

Notice is hereby given of a change in 

the meeting of the National Institute of 

Arthritis and Musculoskeletal and Skin 

Diseases Special Emphasis Panel, March 

29, 2019, 08:00 a.m. to March 29, 2019, 

05:00 p.m., National Institutes of Health, 

One Democracy Plaza, 6701 Democracy 

Boulevard, Bethesda, MD 20892 which 

was published in the Federal Register 

on February 07, 2019, 84 FR 2551. 

This meeting is being amended to 

change the date of the meeting from 

March 29, 2019 to April 1, 2019. This 

meeting is closed to the public. The 

meeting is closed to the public. 

Dated: March 12, 2019. 

Sylvia L. Neal, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2019–04853 Filed 3–14–19; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; 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 grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel; PanelTumor Glycomics. 

Date: April 11, 2019. 

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

Agenda: To review and evaluate grant 

applications. 

Place: National Cancer Institute, Shady 

Grove, 9609 Medical Center Drive, Room 

7W260 Rockville, MD 20850 (Telephone 

Conference Call). 

Contact Person: Clifford W. Schweinfest, 

Ph.D., Scientific Review Officer Special 

Review Branch Division of Extramural 

Activities National Cancer Institute, NIH 

9609 Medical Center Drive, Room 7W108 

Bethesda, MD 20892–9750 240–276–6343 

schweinfestcw@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.392, Cancer Construction; 

93.393, Cancer Cause and Prevention 

Research; 93.394, Cancer Detection and 

Diagnosis Research; 93.395, Cancer 

Treatment Research; 93.396, Cancer Biology 

Research; 93.397, Cancer Centers Support; 

93.398, Cancer Research Manpower; 93.399, 

Cancer Control, National Institutes of Health, 

HHS) 

Dated: March 11, 2019. 

Melanie J. Pantoja, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2019–04851 Filed 3–14–19; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Minority Health 

and Health Disparities; Notice of 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of a meeting of the 

National Advisory Council on Minority 

Health and Health Disparities. 

The meeting will be open to the 

public as indicated below, with 

attendance limited to space available. 

Individuals who plan to attend and 

need special assistance, such as sign 

language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the 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/or 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 grant 

applications and/or contract proposals, 

the disclosure of which would 

constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Advisory 

Council on Minority Health and Health 

Disparities. 

Date: May 20–21, 2019. 

Closed: May 20, 2019, 1:00 p.m. to 

adjournment. 

Agenda: To review and evaluate grant 

applications and/or proposals. 

Place: National Institutes of Health, 6710B 

Rockledge Drive, Conference Rooms 1425– 

1427, Bethesda, MD 20892. 

Open: May 21, 2019, 8:00 a.m. to 2:00 p.m. 

Agenda: The agenda will include opening 

remarks, administrative matters, Director’s 

report, NIH Health Disparities update, and 

other business of the Council. 

Place: National Institutes of Health, 6710B 

Rockledge Drive, Conference Rooms 1425– 

1427, Bethesda, MD 20892. 

Contact Person: Dr. Joyce A. Hunter, 

Deputy Director, NIMHD, National Institutes 

of Health, National Institute on Minority