Federal Register / Vol. 83, No. 117 / Monday, June 18, 2018 / Notices 28243 

ICH Assembly is responsible for the 

endorsement of draft guidelines and 

adoption of final guidelines. FDA 

publishes ICH guidelines as FDA 

guidances. 

ICH S9 (2010) was a significant 

advance in harmonizing anticancer drug 

development. Implementation of ICH S9 

(2010) has revealed areas that are open 

to broad and divergent interpretation by 

both regulatory authorities and industry. 

For this reason, an Implementation 

Working Group (IWG) was formed in 

October 2014 to provide additional 

clarity about anticancer pharmaceutical 

development. The questions and 

answers developed by the IWG are 

intended to facilitate the 

implementation of ICH S9 (2010), as 

well as to continue progress in the 3Rs 

of Reduction, Refinement, and 

Replacement in the use of animals. 

In the Federal Register of September 

19, 2016 (81 FR 64178), FDA published 

a notice announcing the availability of 

a draft guidance entitled ‘‘S9 

Nonclinical Evaluation for Anticancer 

Pharmaceuticals—Questions and 

Answers.’’ The notice gave interested 

persons an opportunity to submit 

comments by November 18, 2016. 

After consideration of the comments 

received and revisions to the guideline, 

a final draft of the guideline was 

submitted to the ICH Assembly and 

endorsed by the regulatory agencies in 

June 2016. 

The guidance provides 

recommendations on development of 

anticancer pharmaceuticals, including 

small molecule and biotechnologyderived products. The questions and 

answers are intended to provide clarity 

and to facilitate a harmonized approach 

to the implementation of ICH S9 (2010). 

Since the publication of the draft 

questions and answers and receipt of 

public comments, some questions were 

combined for brevity and clarity or were 

deleted as redundant or due to lack of 

harmonization. Several areas of 

particular importance include 

additional clarity around the scope of 

the guidance, additional 

recommendations regarding 

development of antibody-drug 

conjugates, and the need for recovery 

animals in general toxicology studies. 

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 ‘‘S9 Nonclinical 

Evaluation for Anticancer 

Pharmaceuticals—Questions and 

Answers.’’ 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. Electronic Access 

Persons with access to the internet 

may obtain the document at https://

www.regulations.gov, https://

www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm, or https://

www.fda.gov/BiologicsBloodVaccines/ 

GuidanceComplianceRegulatory

Information/Guidances/default.htm. 

Dated: June 12, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–12975 Filed 6–15–18; 8:45 am] 

BILLING CODE 4164–01–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: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; Immunity in the Elderly 

(R01). 

Date: July 9–10, 2018. 

Time: 9:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, LD30, 

5601 Fishers Lane, Rockville, MD 20892. 

Contact Person: Julio Aliberti, Ph.D., 

Scientific Review Officer, Scientific Review 

Program, DEA/NIAID/NIH/DHHS, 5601 

Fishers Lane, MSC–9823, Rockville, MD 

20852, 301–761–7322, alibertijc@

niaid.nih.gov. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; Maintaining Immunity after 

Immunization (U01). 

Date: July 11–12, 2018. 

Time: 8:30 a.m. to 2:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 5601 

Fishers Lane, Rockville, MD 20892. 

Contact Person: Geetanjali Bansal, Ph.D., 

Scientific Review Officer, Scientific Review 

Program, Division of Extramural Activities, 

Room 3G49, National Institutes of Health/ 

NIAID, 5601 Fishers Lane, MSC 9834, 

Bethesda, MD 20892–9834, (240) 669–5073, 

geetanjali.bansal@nih.gov. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; NIAID Investigator Initiated 

Program Project (P01). 

Date: July 11, 2018. 

Time: 1:00 p.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: Raymond R. Schleef, 

Ph.D., Senior Scientific Review Officer, 

Scientific Review Program, Division of 

Extramural Activities, Room 3E61, National 

Institutes of Health/NIAID, 5601 Fishers 

Lane, MSC 9823, Bethesda, MD 20892–9823, 

(240) 669–5019, schleefrr@niaid.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: June 12, 2018. 

Natasha M. Copeland, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2018–12921 Filed 6–15–18; 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 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: Center for Scientific 

Review Special Emphasis Panel; PAR: 

Selected Topics in Transfusion Medicine. 

Date: June 28–29, 2018. 

Time: 10:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 


amozie on DSK3GDR082PROD with NOTICES1
28244 Federal Register / Vol. 83, No. 117 / Monday, June 18, 2018 / Notices 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Katherine M. Malinda, 

Ph.D., Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4140, 

MSC 7814, Bethesda, MD 20892, 301–435– 

0912, Katherine_Malinda@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: AIDS and AIDS Related Research. 

Date: July 10, 2018. 

Time: 10:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Shalanda A. Bynum, 

Ph.D., MPH, Scientific Review Officer, Center 

for Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3206, 

Bethesda, MD 20892, 301–755–4355, 

bynumsa@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Convergent 

Neuroscience: From Genomic Association to 

Causation. 

Date: July 10, 2018. 

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

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Jana Drgonova, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5213, 

Bethesda, MD 20892, 301–827–2549, 

jdrgonova@mail.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Small 

Business: Neuroscience Assay, Diagnostics 

and Animal Model Development. 

Date: July 12–13, 2018. 

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

Agenda: To review and evaluate grant 

applications. 

Place: The Crown Plaza Seattle Hotel, 1113 

6th Ave., Seattle, WA 98101. 

Contact Person: Susan Gillmor, Ph.D., 

Scientific Review Officer, National Institutes 

of Health, Center for Scientific Review, 6701 

Rockledge Drive, Bethesda, MD 20892, 301– 

435–1730, susan.gillmor@nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Center for 

Neuroscience and Regenerative Medicine 

Program. 

Date: July 12, 2018. 

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

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Chittari V. Shivakumar, 

Ph.D., Scientific Review Officer, National 

Institutes of Health, Center for Scientific 

Review, 6701 Rockledge Drive, Bethesda, MD 

20892, 301–408–9098, chittari.shivakumar@

nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; PAR 

Review: Understanding and Modifying 

Temporal Dynamics of Coordinated Neural 

Activity. 

Date: July 12, 2018. 

Time: 11:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Jana Drgonova, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5213, 

Bethesda, MD 20892, 301–827–2549, 

jdrgonova@mail.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: Integrative Neuroscience. 

Date: July 12, 2018. 

Time: 1:00 p.m. to 3:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Telephone Conference Call). 

Contact Person: Jasenka Borzan, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4214, 

MSC 7814, Bethesda, MD 20892–7814, 301– 

435–1787, borzanj@csr.nih.gov. 

Name of Committee: Biology of 

Development and Aging Integrated Review 

Group; International and Cooperative 

Projects—1 Study Section. 

Date: July 13, 2018. 

Time: 10:30 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892. 

Contact Person: Seetha Bhagavan, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5194, 

MSC 7846, Bethesda, MD 20892, (301) 237– 

9838, bhagavas@csr.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: June 12, 2018. 

Natasha M. Copeland, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2018–12920 Filed 6–15–18; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Chemical Facility Anti-Terrorism 

Standards Personnel Surety Program 

AGENCY: National Protection and 

Programs Directorate (NPPD), 

Department of Homeland Security 

(DHS). 

ACTION: 30-Day notice and request for 

comments; revision of information 

collection request: 1670–0029. 

SUMMARY: The DHS NPPD Office of 

Infrastructure Protection (IP), 

Infrastructure Security Compliance 

Division (ISCD) will submit the 

following information collection request 

(ICR) to the Office of Management and 

Budget (OMB) for review and clearance 

in accordance with the Paperwork 

Reduction Act of 1995. NPPD 

previously published this ICR, in the 

Federal Register on December 27, 2017, 

for a 60-day public comment period. 

In this notice NPPD is responding to 

seven commenters that submitted 

comments in response to the 60-day 

notice previously published for this ICR 

and soliciting public comment 

concerning this ICR for an additional 30 

days. 

DATES: Comments are encouraged and 

will be accepted until July 18, 2018. 

ADDRESSES: Interested persons are 

invited to submit written comments on 

the proposed information collection to 

the Office of Information and Regulatory 

Affairs, OMB. Comments should be 

addressed to OMB Desk Officer, 

Department of Homeland Security, 

National Protection and Programs 

Directorate and sent via electronic mail 

to dhsdeskofficer@omb.eop.gov. All 

submissions must include the words 

‘‘Department of Homeland Security’’ 

and the OMB Control Number 1670– 

0029. 

Comments submitted in response to 

this notice may be made available to the 

public through relevant websites. For 

this reason, please do not include in 

your comments information of a 

confidential nature, such as sensitive 

personal information or proprietary 

information. Please note that responses 

to this public comment request 

containing any routine notice about the 

confidentiality of the communication 

will be treated as public comments that 

may be made available to the public 

notwithstanding the inclusion of the 

routine notice. 

Comments that include trade secrets, 

confidential commercial or financial 

information, Chemical-terrorism 

Vulnerability Information (CVI), 

Sensitive Security Information (SSI), or 

Protected Critical Infrastructure 

Information (PCII) should not be 

submitted to the public regulatory 

docket. Please submit such comments 

separately from other comments in 

response to this notice. Comments 

containing trade secrets, confidential 

commercial or financial information, 

CVI, SSI, or PCII should be 

appropriately marked and packaged in 


amozie on DSK3GDR082PROD with NOTICES1