Federal Register / Vol. 81, No. 20 / Monday, February 1, 2016 / Notices 5129 

Leroy A. Richardson, 

Chief, Information Collection Review Office, 

Office of Scientific Integrity, Office of the 

Associate Director for Science, Office of the 

Director, Centers for Disease Control and 

Prevention. 

[FR Doc. 2016–01722 Filed 1–29–16; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2016–N–0001] 

Psychopharmacologic Drugs Advisory 

Committee; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: 

Psychopharmacologic Drugs Advisory 

Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the Agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on March 29, 2016, from 8 a.m. to 

5 p.m. 

Location: FDA White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31 

Conference Center, the Great Room (Rm. 

1503), Silver Spring, MD 20993–0002. 

Answers to commonly asked questions 

including information regarding special 

accommodations due to a disability, 

visitor parking, and transportation may 

be accessed at: http://www.fda.gov/

AdvisoryCommittees/

AboutAdvisoryCommittees/

ucm408555.htm. 

Contact Person: Kalyani Bhatt, Center 

for Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 31, Rm. 2417, 

Silver Spring, MD 20993–0002, 301– 

796–9001, FAX: 301–847–8533, PDAC@

fda.hhs.gov, or FDA Advisory 

Committee Information Line, 1–800– 

741–8138 (301–443–0572 in the 

Washington, DC area). A notice in the 

Federal Register about last minute 

modifications that impact a previously 

announced advisory committee meeting 

cannot always be published quickly 

enough to provide timely notice. 

Therefore, you should always check the 

Agency’s Web site at http://

www.fda.gov/AdvisoryCommittees/

default.htm and scroll down to the 

appropriate advisory committee meeting 

link, or call the advisory committee 

information line to learn about possible 

modifications before coming to the 

meeting. 

Agenda: The committee will discuss 

the specific risk-benefit profile for new 

drug application (NDA) 207318, 

NUPLAZID (pimavanserin) 17 milligram 

(mg) immediate-release, film-coated oral 

tablets, submitted by Acadia 

Pharmaceuticals Inc., for the proposed 

treatment of psychosis associated with 

Parkinson’s disease. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

available at http://www.fda.gov/

AdvisoryCommittees/Calendar/

default.htm. Scroll down to the 

appropriate advisory committee meeting 

link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before March 15, 2016. 

Oral presentations from the public will 

be scheduled between approximately 1 

p.m. and 2 p.m. Those individuals 

interested in making formal oral 

presentations should notify the contact 

person and submit a brief statement of 

the general nature of the evidence or 

arguments they wish to present, the 

names and addresses of proposed 

participants, and an indication of the 

approximate time requested to make 

their presentation on or before March 7, 

2016. Time allotted for each 

presentation may be limited. If the 

number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by March 8, 2016. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

Agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with disabilities. 

If you require accommodations due to a 

disability, please contact Kalyani Bhatt 

at least 7 days in advance of the 

meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

http://www.fda.gov/

AdvisoryCommittees/

AboutAdvisoryCommittees/

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: January 27, 2016. 

Jill Hartzler Warner, 

Associate Commissioner for Special Medical 

Programs. 

[FR Doc. 2016–01752 Filed 1–29–16; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

[Document Identifier: HHS–OS–0990–XXXX– 

60D] 

Agency Information Collection 

Activities; Proposed Collection; Public 

Comment Request 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with section 

3506(c)(2)(A) of the Paperwork 

Reduction Act of 1995, the Office of the 

Secretary (OS), Department of Health 

and Human Services, announces plans 

to submit a new Information Collection 

Request (ICR), described below, to the 

Office of Management and Budget 

(OMB). Prior to submitting the ICR to 

OMB, OS seeks comments from the 

public regarding the burden estimate, 

below, or any other aspect of the ICR. 

DATES: Comments on the ICR must be 

received on or before April 1, 2016. 

ADDRESSES: Submit your comments to 

Information.CollectionClearance@

hhs.gov or by calling (202) 690–6162. 

FOR FURTHER INFORMATION CONTACT: 

Information Collection Clearance staff, 

Information.CollectionClearance@

hhs.gov or (202) 690–6162. 

SUPPLEMENTARY INFORMATION: When 

submitting comments or requesting 

information, please include the 

document identifier HHS–OS–0990– 

XXXX–60D for reference. 

Information Collection Request Title: 

Surgeon General’s Pledge to Stem the 

Opioid Epidemic 

Abstract: The Office of the Surgeon 

General, Office of the Secretary, 

Department of Health and Human 


rmajette on DSK2TPTVN1PROD with NOTICES
5130 Federal Register / Vol. 81, No. 20 / Monday, February 1, 2016 / Notices 

Services (HHS) requests that the Office 

of Management and Budget (OMB) 

approve an information request for the 

Surgeon General’s Pledge to Stem the 

Opioid Epidemic. This information 

request involves collecting information 

from users for this pledge which recruits 

doctors, dentists, nurses, and physician 

assistants to utilize their unique 

position in the community and in their 

practice to take notice of the opioid 

crisis and commit to taking action that 

could save lives. 

Likely Respondents: Physicians, 

dentists, physician assistants, nurses, 

nurse practitioners. 

TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS

Form name Number of 

respondents 

Number of 

responses 

per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

Pledge .............................................................................................................. 10,000 1 0.067 670 

OS specifically requests comments on 

(1) the necessity and utility of the 

proposed information collection for the 

proper performance of the agency’s 

functions, (2) the accuracy of the 

estimated burden, (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected, and (4) the 

use of automated collection techniques 

or other forms of information 

technology to minimize the information 

collection burden. 

Darius Taylor, 

Information Collection Clearance Officer. 

[FR Doc. 2016–01750 Filed 1–29–16; 8:45 am] 

BILLING CODE 4150–28–P 

DEPARTMENT OF THE INTERIOR 

Fish and Wildlife Service 

[FWS–R8–ES–2016–N001; 

FXES11120800000–167–FF08EVEN00] 

Receipt of Application for Renewal of 

Incidental Take Permit for Ohlone Tiger 

Beetle; Low-Effect Habitat 

Conservation Plan for the Santa Cruz 

Gardens Unit 12 Project Site; Soquel, 

Santa Cruz County, California 

AGENCY: Fish and Wildlife Service, 

Interior. 

ACTION: Notice of receipt of permit 

renewal application; request for 

comments. 

SUMMARY: We, the U.S. Fish and 

Wildlife Service (Service), have received 

an application from HPH Properties, 

L.P. (applicant), for a renewal of 

incidental take permit TE189382–1 

under the Endangered Species Act of 

1973, as amended (Act). The applicant 

has requested a renewal that will extend 

permit expiration by 6 years from the 

date the permit is reissued. The 

applicant has agreed to follow all of the 

existing low-effect habitat conservation 

plan (HCP) conditions. If renewed, no 

additional take will be authorized. The 

permit would authorize take of the 

federally endangered Ohlone tiger beetle 

(Cicindela ohlone), incidental to 

otherwise lawful activities associated 

with the Santa Cruz Gardens Unit 12 

residential development. 

DATES: Written comments should be 

received on or before March 2, 2016. 

ADDRESSES: Obtaining Documents: You 

may obtain a copy of the permit renewal 

application and the HCP by writing to 

the Ventura Fish and Wildlife 

Ecological Services Office, Attn: Permit 

number TE189382–1, U.S. Fish and 

Wildlife Service, 2493 Portola Road, 

Suite B, Ventura, CA 93003. In addition, 

we will make the permit renewal 

application and HCP available for 

public inspection by appointment 

during normal business hours at the 

above address. 

Submitting Comments: Please address 

written comments to Steve Henry, Field 

Supervisor, Ventura Fish and Wildlife 

Office, U.S. Fish and Wildlife Service, 

2493 Portola Road, Suite B, Ventura, CA 

93003. Comments may also be sent by 

facsimile to (805) 644–3958. 

FOR FURTHER INFORMATION CONTACT: 

Lena Chang, Fish and Wildlife Biologist, 

Ventura Fish and Wildlife Office, at the 

above address or by calling (805) 644– 

1766. 

SUPPLEMENTARY INFORMATION: We have 

received an application from HPH 

Properties, L.P., for a renewal of 

incidental take permit TE189382–1 for 

the endangered Ohlone tiger beetle 

under the Act. The applicant has 

requested a renewal that will extend the 

permit expiration by 6 years. The 

applicant has agreed to follow all of the 

existing HCP conditions. If the permit is 

renewed, no additional take will be 

authorized. The permit would authorize 

take of the federally endangered Ohlone 

tiger beetle, incidental to otherwise 

lawful activities associated with the 

Santa Cruz Gardens Unit 12 residential 

development. In addition to the Ohlone 

tiger beetle, the HCP includes two 

plants: The federally threatened Santa 

Cruz tarplant (Holocarpha macradenia) 

and Gairdner’s yampah (Perideridia 

gairdneri ssp. gairdneri), classified as a 

Rank 4 rare plant by the California 

Native Plant Society. 

Background 

The Ohlone tiger beetle was listed by 

the U.S. Fish and Wildlife Service as 

endangered on October 3, 2001. Section 

9 of the Act (16 U.S.C. 1531 et seq.) and 

its implementing regulations prohibit 

the ‘‘take’’ of fish or wildlife species 

listed as endangered or threatened. 

‘‘Take’’ is defined under the Act to 

include the following activities: ‘‘[T]o 

harass, harm, pursue, hunt, shoot, 

wound, kill, trap, capture, or collect, or 

to attempt to engage in any such 

conduct’’ (16 U.S.C. 1532); however, 

under section 10(a)(1)(B) of the Act, we 

may issue permits to authorize 

incidental take of listed species. 

‘‘Incidental Take’’ is defined by the Act 

as take that is incidental to, and not the 

purpose of, carrying out of an otherwise 

lawful activity. Regulations governing 

incidental take permits for threatened 

and endangered species are, 

respectively, in the Code of Federal 

Regulations at 50 CFR 17.32 and 17.22. 

Issuance of an incidental take permit 

also must not jeopardize the existence of 

federally listed fish, wildlife, or plant 

species. All species included in the 

incidental take permit would receive 

assurances under our ‘‘No Surprises’’ 

regulations (50 CFR 17.22(b)(5) and 

17.32(b)(5)). 

On July 21, 2014, incidental take 

permit TE189382–0 was transferred 

from the original permittee, PorterLivingston Development, Inc. and 

O’Hara-Balfour LP, to a new permittee, 

HPH Properties, L.P. Subsequently, a 

new permit number, TE189382–1, was 

issued. HPH Properties, L.P. has applied 

for renewal of a permit for the 

incidental take of the endangered 

Ohlone tiger beetle. The potential taking 

would occur incidental to development 

of nine new single-family residences at 

an undeveloped 58.6-acre project site 


rmajette on DSK2TPTVN1PROD with NOTICES