61766 Federal Register / Vol. 82, No. 249 / Friday, December 29, 2017 / Notices 

under control number 0910–0014. The 

information collection described in the 

guidance for industry entitled ‘‘Formal 

Meetings Between the FDA and 

Sponsors or Applicants of PDUFA 

Products’’ is approved by OMB under 

control number 0910–0429. The 

information collection described in the 

guidance for industry entitled ‘‘Formal 

Dispute Resolution: Sponsor Appeals 

Above the Division Level’’ (available at 

https://www.fda.gov/downloads/Drugs/ 

GuidanceComplianceRegulatory

Information/Guidances/ 

UCM343101.pdf) is approved by OMB 

under control number 0910–0430. The 

information collection described in the 

‘‘Evaluation of the Program for 

Enhanced Review Transparency and 

Communication for New Molecular 

Entity New Drug Applications and 

Original Biologics License Applications 

in Prescription Drug User Fee Acts’’ is 

approved by OMB under control 

number 0910–0746. The information 

collection described in the guidance for 

industry entitled ‘‘Expedited Programs 

for Serious Conditions—Drugs and 

Biologics’’ (available at https://

www.fda.gov/downloads/Drugs/ 

GuidanceComplianceRegulatory

Information/Guidances/ 

UCM358301.pdf) is approved by OMB 

under control number 0910–0765. The 

information collection described in the 

guidance for industry entitled ‘‘Formal 

Meetings Between the FDA and 

Biosimilar Biological Product Sponsors 

or Applicants’’ (available at https://

www.fda.gov/downloads/Drugs/ 

GuidanceComplianceRegulatory

Information/Guidances/ 

UCM345649.pdf) is approved by OMB 

under control number 0910–0802. 

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: December 19, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–28139 Filed 12–28–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Meeting of the Advisory Committee on 

Minority Health 

AGENCY: Office of Minority Health, 

Office of the Secretary, Department of 

Health and Human Services. 

ACTION: Notice of meeting. 

SUMMARY: As stipulated by the Federal 

Advisory Committee Act, the 

Department of Health and Human 

Services (HHS) is hereby giving notice 

that the Advisory Committee on 

Minority Health (ACMH) will hold a 

meeting. This meeting will be open to 

the public. Preregistration is required 

for both public attendance and 

comment. Any individual who wishes 

to attend the meetings and/or 

participate in the public comment 

session should email OMH-ACMH@

hhs.gov. Information about the meeting 

is available from the designated contact 

and will be posted on the website for 

the Office of Minority Health (OMH), 

www.minorityhealth.hhs.gov. 

Information about ACMH activities can 

be found on the OMH website under the 

heading About OMH. 

DATES: The meeting will be held on 

Monday, March 26, 2018, from 9:00 a.m. 

to 5:00 p.m. and Tuesday, March 27, 

2018, from 9:00 a.m. to 1:00 p.m. 

ADDRESSES: The meeting will be held at 

the 5600 Fishers Lane Building, Room 

05E29, 5600 Fishers Lane, Rockville, 

Maryland 20857. 

FOR FURTHER INFORMATION CONTACT: Dr. 

Minh Wendt, Designated Federal 

Officer, Advisory Committee on 

Minority Health, Office of Minority 

Health, Department of Health and 

Human Services, Tower Building, 1101 

Wootton Parkway, Suite 600, Rockville, 

Maryland 20852. Phone: 240–453–8222; 

fax: 240–453–8223; email OMH-ACMH@

hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

accordance with Public Law 105–392, 

the ACMH was established to provide 

advice to the Deputy Assistant Secretary 

for Minority Health on improving the 

health of each racial and ethnic 

minority group and on the development 

of goals and specific program activities 

of the OMH. 

The topics to be discussed during this 

meeting will include strategies to 

improve the health of racial and ethnic 

minority populations through the 

development of health policies and 

programs that will help eliminate health 

disparities with an emphasis on serious 

mental illness. The recommendations 

will be given to the Deputy Assistant 

Secretary for Minority Health. 

Public attendance at this meeting is 

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 

designated contact person at least 

fourteen (14) business days prior to the 

meeting. Members of the public will 

have an opportunity to provide 

comments at the meeting. Public 

comments will be limited to three 

minutes per speaker. Individuals who 

would like to submit written statements 

should mail or fax their comments to 

the Office of Minority Health at least 

seven (7) business days prior to the 

meeting. Any members of the public 

who wish to have printed material 

distributed to ACMH committee 

members should submit their materials 

to the Designated Federal Officer, 

ACMH, Tower Building, 1101 Wootton 

Parkway, Suite 600, Rockville, 

Maryland 20852, prior to close of 

business on Monday, March 19, 2018. 

Dated: December 22, 2017. 

Minh Wendt, 

Designated Federal Officer, Advisory 

Committee on Minority Health. 

[FR Doc. 2017–28161 Filed 12–28–17; 8:45 am] 

BILLING CODE 4150–29–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: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; AIDS Research Review 

Committee (AIDSRRC) Independent SEP. 

Date: January 18, 2018. 

Time: 1:00 p.m. to 2:00 p.m. 

Agenda: To review and evaluate grant 

applications. 


ethrower on DSK3G9T082PROD with NOTICES
Federal Register / Vol. 82, No. 249 / Friday, December 29, 2017 / Notices 61767 

Place: National Institutes of Health, 5601 

Fishers Lane, Rockville, MD 20892 

(Telephone Conference Call). 

Contact Person: Robert C. Unfer, Ph.D., 

Scientific Review Officer, Scientific Review 

Program, DEA/NIAID/NIH/DHHS, 5601 

Fishers Lane, Room 3F40 MSC 9823, 

Rockville, MD 20892–9823, 240–669–5035, 

unferrc@nih.gov. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; PHS 2018–1 Topic 54 & 55: 

Adjuvant Discovery & Development for 

Autoimmune Diseases. 

Date: January 31, 2018. 

Time: 11:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: National Institutes of Health, 5601 

Fishers Lane, Rockville, MD 20892 

(Telephone Conference Call). 

Contact Person: Dharmendar Rathore, 

Ph.D., Scientific Review Officer, Scientific 

Review Program, Division of Extramural 

Activities, Room 3G30, National Institutes of 

Health/NIAID, 5601 Fishers Lane, Drive, 

MSC 9823, Bethesda, MD 20892–9823, 240– 

669–5058, rathored@mail.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: December 22, 2017. 

Sylvia L. Neal, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2017–28155 Filed 12–28–17; 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 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: National Institute of 

Neurological Disorders and Stroke, Initial 

Review Group, Neurological Sciences and 

Disorders B. 

Date: February 22, 2018. 

Time: 8:00 a.m. to 3:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: JW Marriott New Orleans, 614 Canal 

Street, New Orleans, LA 70130. 

Contact Person: Birgit Neuhuber, Ph.D., 

Scientific Review Officer, Scientific Review 

Branch, NINDS/NIH/DHHS, Neuroscience 

Center, 6001 Executive Blvd., Suite 3204, 

MSC 9529, Bethesda, MD 20892–9529, 

neuhuber@ninds.nih.gov. 

Name of Committee: National Institutes of 

Neurological Disorders and Stroke, Special 

Emphasis Panel, NSD Member Conflict SEP. 

Date: February 22, 2018. 

Time: 4:00 p.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: JW Marriott New Orleans, 614 Canal 

Street, New Orleans, LA 70130. 

Contact Person: Birgit Neuhuber, Ph.D., 

Scientific Review Officer, Scientific Review 

Branch, NINDS/NIH/DHHS, Neuroscience 

Center, 6001 Executive Blvd., Suite 3204, 

MSC 9529, Bethesda, MD 20892–9529, 

neuhuber@ninds.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: December 22, 2017. 

Sylvia L. Neal, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2017–28157 Filed 12–28–17; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Aging; 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 on 

Aging Initial Review Group; Behavior and 

Social Science of Aging Review Committee 

NIA–S. 

Date: February 1–2, 2018. 

Time: 10:00 a.m. to 3:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Bethesda North Marriott Hotel & 

Conference Center, 5701 Marinelli Road, 

Bethesda, MD 20852. 

Contact Person: Kimberly Firth, Ph.D., 

National Institute on Aging, Gateway 

Building, 7201 Wisconsin Avenue, Suite 

2C212, Bethesda, MD 20892, 301–402–7702, 

kimberly.firth@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.866, Aging Research, 

National Institutes of Health, HHS) 

Dated: December 26, 2017. 

David Clary, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2017–28154 Filed 12–28–17; 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 

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 

Allergy and Infectious Diseases Special 

Emphasis Panel; PHS 2018–1 Topic 55: 

Adjuvant Development for Viral Diseases 

Vaccines. 

Date: January 26, 2018. 

Time: 11:00 a.m. to 4:00 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: National Institutes of Health, 5601 

Fishers Lane, Rockville, MD 20892 

(Telephone Conference Call). 

Contact Person: Dharmendar Rathore, 

Ph.D., Scientific Review Officer, Scientific 

Review Program, Division of Extramural 

Activities, Room 3G30, National Institutes of 

Health/NIAID, 5601 Fishers Lane, Drive, 

MSC 9823, Bethesda, MD 20892–9823, 240– 

669–5058, rathored@mail.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) 


ethrower on DSK3G9T082PROD with NOTICES