Federal Register / Vol. 80, No. 15 / Friday, January 23, 2015 / Notices 3609 

Section 760(e) (21 U.S.C. 379aa(e) of 

the FD&C Act also requires that 

responsible persons maintain records of 

nonprescription adverse event reports, 

whether or not the event is serious, for 

a period of 6 years. The guidance 

document recommends that 

respondents maintain records of efforts 

to obtain the minimum data elements 

for a report of a serious adverse drug 

event and any follow-up reports. We 

estimate that there are approximately 

20,000 records per year maintained by 

approximately 200 respondents, and 

that it takes approximately 5 hours to 

maintain each record. 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Activity Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

Recordkeeping (21 U.S.C. 379aa(e)(1)) .............................. 200 100 20,000 5 100,000 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Therefore, the estimated annual 

reporting burden for this information is 

25,000 hours and the estimated annual 

recordkeeping burden is 100,000 hours. 

Dated: January 15, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–01111 Filed 1–22–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–N–0001] 

Request for Nominations for Voting 

Members on a Public Advisory 

Committee; Science Board to the Food 

and Drug Administration 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is requesting 

nominations for members to serve on 

the Science Board to the Food and Drug 

Administration, Office of the 

Commissioner, Office of the Chief 

Scientist. FDA seeks to include the 

views of women and men, members of 

all racial and ethnic groups, and 

individuals with and without 

disabilities on its advisory committees 

and, therefore, encourages nominations 

of appropriately qualified candidates 

from these groups. 

DATES: Nominations received on or 

before March 24, 2015 will be given first 

consideration for membership on the 

Science Board to the Food and Drug 

Administration. Nominations received 

after March 24, 2015 will be considered 

for nomination to the committee as later 

vacancies occur. 

ADDRESSES: All nominations for 

membership should be sent 

electronically by logging into the FDA 

Advisory Nomination Portal: http://

www.accessdata.fda.gov/scripts/

FACTRSPortal/FACTRS/index.cfm or by 

mail to Advisory Committee Oversight 

and Management Staff, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 5103, Silver Spring, 

MD 20993–0002. 

FOR FURTHER INFORMATION CONTACT: 

Regarding all nomination questions for 

membership, the primary contact is: 

Martha Monser, Office of the Chief 

Scientist, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 1, Rm. 3309, Silver Spring, 

MD 20993–0002, 301–796–4627, 

martha.monser@fda.hhs.gov. 

Information about becoming a 

member on an FDA advisory committee 

can also be obtained by visiting FDA’s 

Web site by using the following link: 

http://www.fda.gov/

AdvisoryCommittees/default.htm. 

SUPPLEMENTARY INFORMATION: FDA is 

requesting nomination for voting 

members on the Science Board to the 

Food and Drug Administration. 

I. General Description of the Committee 

Duties 

The Science Board shall provide 

advice to the Commissioner and other 

appropriate officials on specific 

complex scientific and technical issues 

important to FDA and its mission, 

including emerging issues within the 

scientific community. Additionally, the 

Science Board will provide advice that 

supports the Agency in keeping pace 

with technical and scientific 

developments, including in regulatory 

science, provide input into the Agency’s 

research agenda, and on upgrading its 

scientific and research facilities and 

training opportunities. It will also 

provide, where requested, expert review 

of Agency sponsored intramural and 

extramural scientific research programs. 

II. Criteria for Voting Members 

The committee consists of a core of 21 

voting members including the chair and 

a co-chair. Members, the chair and the 

co-chair are selected by the 

Commissioner or designee from among 

authorities knowledgeable in the fields 

of: Food science, safety, and nutrition; 

chemistry, pharmacology, translational 

and clinical medicine and research, 

toxicology, biostatistics, medical 

devices, imaging, robotics, cell and 

tissue based products, regenerative 

medicine, public health and 

epidemiology, international health and 

regulation, product safety, product 

manufacturing sciences and quality; and 

other scientific areas relevant to FDA 

regulated products such as systems 

biology, informatics, nanotechnology, 

and combination products. Almost all 

non-Federal members of this committee 

serve as Special Government 

Employees. Members will be invited to 

serve for terms of up to 4 years. 

III. Nomination Procedures 

Any interested person may nominate 

one or more qualified individuals for 

membership on the advisory committee. 

Self-nominations are also accepted. 

Nominations must include a current, 

complete resume or curriculum vitae for 

each nominee, including current 

business address and/or home address, 

telephone number, and email address if 

available. Nominations must also 

specify the advisory committee for 

which the nominee recommended. 

Nominations must also acknowledge 

that the nominee is aware of the 

nomination unless self-nominated. FDA 

will ask potential candidates to provide 

detailed information concerning such 

matters related to financial holdings, 

employment, and research grants and/or 

contracts to permit evaluation of 

possible sources of conflicts of interest. 

This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app. 2) and 21 CFR part 14, 

relating to advisory committees. 


tkelley on DSK3SPTVN1PROD with NOTICES
3610 Federal Register / Vol. 80, No. 15 / Friday, January 23, 2015 / Notices 

Dated: January 15, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–01114 Filed 1–22–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Statement of Organization, Functions 

and Delegations of Authority 

This notice amends Part R of the 

Statement of Organization, Functions 

and Delegations of Authority of the 

Department of Health and Human 

Services (HHS), Health Resources and 

Services Administration (HRSA) (60 FR 

56605, as amended November 6, 1995; 

as last amended at 79 FR 75164–75165 

dated December 17, 2014). 

This notice reflects organizational 

changes in the Health Resources and 

Services Administration (HRSA), 

Healthcare Systems Bureau (HSB). 

Specifically, this notice: (1) Updates the 

functional statement for the Division of 

National Hansen’s Disease Programs 

(RRH). 

Chapter RR—Healthcare Systems 

Bureau 

Section RR—00, Mission 

The Healthcare Systems Bureau (HSB) 

protects the public health and improves 

the health of individuals through an 

array of programs that provide national 

leadership and direction in targeted 

areas. 

Section RR–20, Functions 

Delete the functional statement for the 

Division of National Hansen’s Disease 

Programs (RRH) in its entirety and 

replace with the following: 

Division of National Hansen’s Disease 

Programs (RRH) 

The National Hansen’s Disease 

Programs (NHDP) in accordance with 

regulations of the Public Health Service 

(PHS) Act, Sec. 320 as amended by Sec. 

211, PL105–78); (1) provides care and 

treatment for persons with Hansen’s 

Disease (leprosy), including managing a 

national short-term and outpatient 

health care delivery program providing 

specialized services to persons with 

Hansen’s Disease; (2) conducts and 

promotes the coordination of research 

(including clinical research), 

investigations, demonstrations, and 

studies relating to the causes, diagnosis, 

treatment, control, and prevention of 

Hansen’s disease and other 

mycobacterial diseases and 

complications related to such diseases; 

(3) conducts training in the diagnosis 

and management of Hansen’s disease 

and related complications; (4) provides 

education and training to staff from the 

outpatient Hansen’s Disease Clinics and 

private physicians; (5) operates and 

oversees the National Hansen’s Disease 

Museum and Cemetery; (6) consults on 

the coordination of activities within 

HRSA and HHS, and with other federal 

agencies, state and local governments, 

and other public and private 

organizations involved in Hansen’s 

Disease activities; and (7) manages a 

network of outpatient clinics through 

contracts providing care to persons with 

Hansen’s Disease. 

Section RR–30, Delegations of Authority 

All delegations of authority and redelegations of authority made to HRSA 

officials that were in effect immediately 

prior to this reorganization, and that are 

consistent with this reorganization, 

shall continue in effect pending further 

re-delegation. 

This reorganization is effective upon 

date of signature. 

Dated: January 16, 2015. 

Mary K. Wakefield, 

Administrator. 

[FR Doc. 2015–01131 Filed 1–22–15; 8:45 am] 

BILLING CODE 4165–15–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 (5 U.S.C. App.), 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; NIAID Investigator Initiated 

Program Project Application (P01). 

Date: February 19, 2015. 

Time: 11:00 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 

(Telephone Conference Call). 

Contact Person: Eleazar Cohen, Ph.D., 

Scientific Review Officer, Scientific Review 

Program, Division of Extramural Activities, 

National Institutes of Health, NIAID, 5601 

Fishers Lane, Rockville, MD 20892, 240–669– 

5881, ec17w@nih.gov. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; NIAID Investigator Initiated 

Program Project Applications (P01). 

Date: February 23, 2015. 

Time: 12:00 p.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, Room 

3F100, 5601 Fishers Lane, Rockville, MD 

20892 (Telephone Conference Call). 

Contact Person: Quirijn Vos, Ph.D., 

Scientific Review Officer, Scientific Review 

Program, Division of Extramural Activities, 

DHHS/NIH/NIAID, 5601 Fishers Lane, 

Rockville, MD 20892, 240–669–5059, qvos@

niaid.nih.gov. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; NIAID Investigator Initiated 

Program Project Applications (P01). 

Date: February 26, 2015. 

Time: 11:00 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 

(Telephone Conference Call). 

Contact Person: Eleazar Cohen, Ph.D., 

Scientific Review Officer, Scientific Review 

Program, Division of Extramural Activities, 

National Institutes of Health, NIAID, 5601 

Fishers Lane, Rockville, MD 20892, 240–669– 

5881, ec17w@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 16, 2015. 

David Clary, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2015–01087 Filed 1–22–15; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Diabetes and 

Digestive and Kidney Diseases; Notice 

of Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

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

hereby given of the following meetings. 

The meetings will be closed to the 

public in accordance with the 


tkelley on DSK3SPTVN1PROD with NOTICES