Federal Register / Vol. 84, No. 23 / Monday, February 4, 2019 / Notices 1471 

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 

‘‘Labeling for Human Prescription Drug 

and Biological Products Approved 

Under the Accelerated Approval 

Regulatory Pathway.’’ Labeling must 

conform to the content and format 

requirements delineated in §§ 201.57(d) 

and 201.57 (21 CFR 201.56(d) and 

201.57). Labeling for drugs approved 

under the accelerated approval process 

is fundamentally the same as for drugs 

approved under the traditional pathway; 

however, for drugs approved under 

accelerated approval there are 

additional labeling requirements as 

described in § 201.57(c)(2)(i)(B) and 

recommended elements for 

consideration. This guidance discusses 

FDA’s recommendations for developing 

the indication and usage statements in 

the prescribing information for drugs 

approved under accelerated approval as 

defined in 21 CFR part 314, subpart H 

(for new drug applications) and 21 CFR 

part 601, subpart E (for biologics license 

applications), specifically 21 CFR 

314.510 and 21 CFR 601.41. The 

guidance also discusses labeling 

considerations for indications approved 

under accelerated approval when 

clinical benefit has been verified and 

FDA terminates the conditions of 

accelerated approval under 21 CFR 

314.560 or 21 CFR 601.46, or when FDA 

withdraws accelerated approval of an 

indication while other indications for 

the drug remain approved. 

This guidance finalizes the draft 

guidance of the same name issued 

March 25, 2014 (79 FR 16344). Changes 

from the draft guidance include the 

recommendations regarding how to 

fulfill the regulatory requirement that 

the labeling for drugs approved under 

accelerated approval include a succinct 

description of the limitations of 

usefulness of the drug and any 

uncertainty about clinical benefits. The 

draft guidance proposed recommending 

inclusion of a statement in the 

indication describing the specific 

clinical benefit that remains to be 

established; the final guidance states 

that simply reporting the endpoint used, 

without this additional statement, may 

be sufficient, except in certain 

circumstances when additional context 

about the approval should be included. 

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 labeling for human 

prescription drug and biological 

products approved under accelerated 

approval. 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 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 guidance at https://

www.fda.gov/Drugs/ 

GuidanceCompliance

RegulatoryInformation/Guidances/

default.htm, https://www.fda.gov/ 

BiologicsBloodVaccines/

GuidanceComplianceRegulatory

Information/default.htm, or https://

www.regulations.gov. 

Dated: January 16, 2019. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2019–00894 Filed 2–1–19; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Meeting of the National Clinical Care 

Commission 

AGENCY: Office of Disease Prevention 

and Health Promotion, Office of the 

Assistant Secretary for Health, Office of 

the Secretary, Department of Health and 

Human Services. 

ACTION: Notice. 

SUMMARY: The National Clinical Care 

Commission (the Commission) will 

conduct a virtual meeting on February 

20, 2019. The Commission is charged to 

evaluate and make recommendations to 

the U.S. Department of Health and 

Human Services (HHS) Secretary and 

Congress regarding improvements to the 

coordination and leveraging of federal 

programs related to awareness and 

clinical care for complex metabolic or 

autoimmune diseases that result from 

issues related to insulin that represent a 

significant disease burden in the United 

States, which may include 

complications due to such diseases. 

DATES: The meeting will take place on 

February 20, 2019, from 1:00 p.m. to 

approximately 5:00 p.m. Eastern Time 

(ET). 

ADDRESSES: The meeting will be held 

online via webinar. To register to attend 

the meeting, please visit the registration 

website at https://

events.kauffmaninc.com/events/nccc2/ 

register/?t=24. 

FOR FURTHER INFORMATION CONTACT: 

Clydette Powell, Designated Federal 

Officer, National Clinical Care 

Commission, U.S. Department of Health 

and Human Services, Office of the 

Assistant Secretary for Health, Office of 

Disease Prevention and Health 

Promotion, 1101 Wootton Parkway, 

Suite LL–100, Rockville, MD 20852. 

Email: OHQ@hhs.gov. Phone: 240–453– 

8239. Additional information may be 

obtained at https://health.gov/hcq/ 

national-clinical-care-commission.asp. 

SUPPLEMENTARY INFORMATION: The 

National Clinical Care Commission Act 

(Pub. L. 115–80) requires the HHS 

Secretary to establish the National 

Clinical Care Commission. The 

Commission consists of representatives 

of specific federal agencies and nonfederal individuals and entities who 

represent diverse disciplines and views. 

The Commission will evaluate and 

make recommendations to the HHS 

Secretary and Congress regarding 

improvements to the coordination and 

leveraging of federal programs related to 

awareness and clinical care for complex 

metabolic or autoimmune diseases that 

result from issues related to insulin that 

represent a significant disease burden in 

the United States, which may include 

complications due to such diseases. 

The inaugural meeting of the 

Commission was held on October 31, 

2018, during which non-federal 

Commission members were sworn-in, 

and various federal interagency efforts 

surrounding diabetes program were 

presented. This virtual meeting will 

consist of presentations by the 

remaining federal agencies on the 

Commission which were not covered in 

the inaugural meeting. The final 

meeting agenda will be available prior 

to the meeting at https://health.gov/hcq/ 

national-clinical-care-commission.asp. 

Public Participation at Meeting: The 

Commission invites public comment on 

issues related to the Commission’s 

charge. There will be no opportunity for 

oral comments at this virtual meeting. 

Written comments are welcome 


amozie on DSK3GDR082PROD with NOTICES1
1472 Federal Register / Vol. 84, No. 23 / Monday, February 4, 2019 / Notices 

throughout the process of the 

Commission and may be emailed to 

OHQ@hhs.gov, or by mail to the 

following address: Public Commentary, 

National Clinical Care Commission, 

1101 Wootton Parkway, Suite LL–100, 

Rockville, MD 20852. Written comments 

should not exceed three pages in length. 

To virtually attend the Commission 

meeting, individuals must pre-register at 

the registration website at https://

events.kauffmaninc.com/events/nccc2/ 

register/?t=24. Individuals who need 

special assistance, such as sign language 

interpretation or other reasonable 

accommodations, should indicate the 

special accommodation when 

registering online or by notifying 

Jennifer Gillissen at jennifer.gillissen@

kauffmaninc.com by February 11. 

Authority: The National Clinical Care 

Commission is required under the National 

Clinical Care Commission Act (Pub. L. 115– 

80). The Commission is governed by 

provisions of the Federal Advisory 

Committee Act (FACA), Public Law 92–463, 

as amended (5 U.S.C., App.) which sets forth 

standards for the formation and use of federal 

advisory committees. 

Dated: January 24, 2019. 

Donald Wright, 

Deputy Assistant Secretary for Health. 

[FR Doc. 2019–00360 Filed 2–1–19; 8:45 am] 

BILLING CODE 4150–32–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 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 

Child Health and Human Development Initial 

Review Group; Obstetrics and Maternal-Fetal 

Biology Subcommittee. 

Date: February 22, 2019. 

Time: 8:30 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Residence Inn Bethesda, 7335 

Wisconsin Avenue, Bethesda, MD 20814. 

Contact Person: Peter Zelazowski, Ph.D., 

Scientific Review Officer, National Institutes 

of Health, NICHD, SRB, 6710B Rockledge 

Drive, Bethesda, MD 20892, 301–435–6902, 

PETER.ZELAZOWSKI@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: January 30, 2019. 

Ronald J. Livingston, Jr., 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2019–00892 Filed 2–1–19; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; Notice of Closed 

Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings 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: Microbiology, 

Infectious Diseases and AIDS Initial Review 

Group, Microbiology and Infectious Diseases 

Research Committee, Microbiology and 

Infectious Diseases Research Committee 

(MID). 

Date: June 11–12, 2019. 

Time: 8:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 5601 

Fishers Lane, Rockville, MD 20892 

(Telephone Conference Call). 

Contact Person: Amir E. Zeituni, Ph.D., 

Scientific Review Program, Division of 

Extramural Activities, SRP, RM 3G51, 

National Institutes of Health, NIAID, 5601 

Fishers Lane, MSC 9823, Rockville, MD 

20852–9823, 301–496–2550, amir.zeituni@

nih.gov. 

Name of Committee: Microbiology, 

Infectious Diseases and AIDS Initial Review 

Group, Microbiology and Infectious Diseases 

Research Committee, Microbiology and 

Infectious Diseases Research Committee 

(MID). 

Date: October 17–18, 2019. 

Time: 8:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health 5601 

Fishers Lane, Rockville, MD 20892 

(Telephone Conference Call). 

Contact Person: Amir E. Zeituni, Ph.D., 

Scientific Review Program, Division of 

Extramural Activities, SRP, RM 3G51, 

National Institutes of Health, NIAID, 5601 

Fishers Lane, MSC 9823, Rockville, MD 

20852–9823, 301–496–2550, amir.zeituni@

nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

Microbiology and Infectious Diseases 

Research, National Institutes of Health, HHS) 

Dated: January 29, 2019. 

Natasha M. Copeland, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2019–00832 Filed 2–1–19; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; 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 the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; PAR Panel: 

Molecular and Cellular Causal Aspects of 

Alzheimer’s Disease. 

Date: February 28, 2019. 

Time: 8:00 a.m. to 7:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Holiday Inn & Suites Alexandria— 

Old Town, 625 First Street, Alexandria, VA 

22314. 

Contact Person: Carole L. Jelsema, Ph.D., 

Chief and Scientific Review Officer, Center 

for Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4176, 

MSC 7850, Bethesda, MD 20892, (301) 435– 

1248, jelsemac@csr.nih.gov. 


amozie on DSK3GDR082PROD with NOTICES1