12500 Federal Register / Vol. 80, No. 45 / Monday, March 9, 2015 / Notices 

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 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel, Ancillary Study on 

IBD. 

Date: April 8, 2015. 

Time: 4:30 p.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, Two 

Democracy Plaza, 6707 Democracy 

Boulevard, Bethesda, MD 20892, (Telephone 

Conference Call). 

Contact Person: Maria E. Davila-Bloom, 

Ph.D., Scientific Review Officer, Review 

Branch, DEA, NIDDK, National Institutes of 

Health, Room 758, 6707 Democracy 

Boulevard, Bethesda, MD 20892–5452, (301) 

594–7637, davila-bloomm@

extra.niddk.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.847, Diabetes, 

Endocrinology and Metabolic Research; 

93.848, Digestive Diseases and Nutrition 

Research; 93.849, Kidney Diseases, Urology 

and Hematology Research, National Institutes 

of Health, HHS) 

Dated: March 3, 2015. 

David Clary, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2015–05311 Filed 3–6–15; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Advisory Committee on Infant 

Mortality; Notice of Meeting 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), notice is hereby given 

of the following meeting: 

Name: Advisory Committee on Infant 

Mortality (ACIM). 

Dates and Times: 

March 26, 2015, 8:30 a.m.–5:30 p.m. 

March 27, 2015, 8:30 a.m.–3:30 p.m. 

Place: Hyatt Regency Bethesda, One 

Bethesda Metro Center, 7400 Wisconsin 

Avenue, Bethesda, MD 20814. 

Status: The meeting is open to the 

public with attendance limited to space 

availability. For more details and 

registration, please visit the ACIM Web 

site: http://www.hrsa.gov/

advisorycommittees/mchbadvisory/

InfantMortality/index.html. 

Purpose: The Committee provides 

advice and recommendations to the 

Secretary of Health and Human Services 

on the following: Department of Health 

and Human Services’ programs that 

focus on reducing infant mortality and 

improving the health status of infants 

and pregnant women; and factors 

affecting the continuum of care with 

respect to maternal and child health 

care. The Committee focuses on 

outcomes following childbirth; 

strategies to coordinate myriad federal, 

state, local, and private programs and 

efforts that are designed to deal with the 

health and social problems impacting 

on infant mortality; and the 

implementation of the Healthy Start 

Program and Healthy People 2020 infant 

mortality objectives. 

Agenda: Topics that will be discussed 

include the following: HRSA Update; 

MCHB Update; Healthy Start Program 

Update; Updates from Partnering 

Agencies and Organizations; and, 

ACIM’s recommendations for the HHS 

National Strategy to Address Infant 

Mortality, specifically Strategy 4: 

Increase Health Equity and Reduce 

Disparities by Targeting Social 

Determinants of Health through both 

Investments in High-Risk, UnderResourced Communities and Major 

Initiatives to Address Poverty. Proposed 

agenda items are subject to change as 

priorities dictate. 

Time will be provided for public 

comments limited to 5 minutes each. 

Comments are to be submitted in 

writing no later than 5:00 p.m. (EST) on 

March 19, 2015. 

FOR FURTHER INFORMATION CONTACT: 

Anyone requiring information regarding 

the Committee should contact Michael 

C. Lu, M.D., M.P.H., Executive 

Secretary, ACIM, Health Resources and 

Services Administration, Room 18 W, 

Parklawn Building, 5600 Fishers Lane, 

Rockville, Maryland 20857, telephone: 

(301) 443–2170. 

Individuals who are submitting public 

comments or who have questions 

regarding the meeting and location 

should contact David S. de la Cruz, 

Ph.D., M.P.H., ACIM Designated Federal 

Official, HRSA, Maternal and Child 

Health Bureau, telephone: (301) 443– 

0543, or email: David.delaCruz@

hrsa.hhs.gov. 

Jackie Painter, 

Director, Division of the Executive Secretariat. 

[FR Doc. 2015–05416 Filed 3–6–15; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–0913] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; 513(g) Request for 

Information 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by April 8, 

2015. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0705. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

513(g) Request for Information—(OMB 

Control Number 0910–0705)— 

(Extension) 

Section 513(g) of the Federal Food, 

Drug, and Cosmetic Act (the FD&C Act) 

(21 U.S.C. 360c(g)) provides a means for 

obtaining the Agency’s views about the 

classification and regulatory 

requirements that may be applicable to 

a particular device. Section 513(g) 

provides that, within 60 days of the 

receipt of a written request of any 

person for information respecting the 

class in which a device has been 

classified or the requirements applicable 

to a device under the FD&C Act, the 

Secretary of Health and Human Services 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 80, No. 45 / Monday, March 9, 2015 / Notices 12501 

shall provide such person a written 

statement of the classification (if any) of 

such device and the requirements of the 

FD&C Act applicable to the device. 

The guidance document entitled 

‘‘Guidance for Industry and Food and 

Drug Administration Staff; FDA and 

Industry Procedures for Section 513(g) 

Requests for Information Under the 

Federal Food, Drug, and Cosmetic Act’’ 

establishes procedures for submitting, 

reviewing, and responding to requests 

for information respecting the class in 

which a device has been classified or 

the requirements applicable to a device 

under the FD&C Act that are submitted 

in accordance with section 513(g) of the 

FD&C Act. FDA does not review data 

related to substantial equivalence or 

safety and effectiveness in a 513(g) 

request for information. FDA’s 

responses to 513(g) requests for 

information are not device classification 

decisions and do not constitute FDA 

clearance or approval for marketing. 

Classification decisions and clearance or 

approval for marketing require 

submissions under different sections of 

the FD&C Act. Additionally, the FD&C 

Act, as amended by the FDA 

Amendments Act of 2007 (Public Law 

110–85), requires FDA to collect user 

fees for 513(g) requests for information. 

The guidance document entitled 

‘‘Guidance for Industry and Food and 

Drug Administration Staff; User Fees for 

513(g) Requests for Information’’ assists 

FDA staff and regulated industry by 

describing the user fees associated with 

513(g) requests. The Medical Device 

User Fee Cover Sheet (Form FDA 3601), 

which accompanies the supplemental 

material described in this information 

collection, is approved under OMB 

control number 0910–0511 and expires 

April 30, 2016. 

In the Federal Register of July 22, 

2014 (79 FR 42517), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Center for Devices and Radiological Health 513(g) requests ............. 114 1 114 12 1,368 

Center for Biologics Evaluation and Research 513(g) requests ......... 4 1 4 12 48 

Total .............................................................................................. .................... ........................ .................... .................... 1,416 

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

Respondents to this collection of 

information are mostly device 

manufacturers; however, anyone may 

submit a 513(g) request for information. 

The total number of annual responses is 

based on the average number of 513(g) 

requests received each year by the 

Agency. 

Dated: March 2, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–05358 Filed 3–6–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0166] 

International Cooperation on 

Harmonisation of Technical 

Requirements for Registration of 

Veterinary Medicinal Products; Studies 

To Evaluate the Metabolism and 

Residue Kinetics of Veterinary Drugs 

in Food-Producing Animals: Marker 

Residue Depletion Studies To 

Establish Product Withdrawal Periods; 

Revised Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a revised guidance for 

industry (GFI #207) entitled ‘‘Studies to 

Evaluate the Metabolism and Residue 

Kinetics of Veterinary Drugs in FoodProducing Animals: Marker Residue 

Depletion Studies to Establish Product 

Withdrawal Periods’’ (VICH GL48(R)). 

This revised guidance, which provides 

minor updates to a final guidance on the 

same topic for which a notice of 

availability was published in the 

Federal Register of September 15, 2011 

(2011 guidance), has been developed for 

veterinary use by the International 

Cooperation on Harmonisation of 

Technical Requirements for Registration 

of Veterinary Medicinal Products 

(VICH). This revised VICH guidance is 

intended to provide study design 

recommendations that will facilitate the 

universal acceptance of the generated 

residue depletion data to fulfill the 

national/regional requirements. 

DATES: Submit either electronic or 

written comments on Agency guidances 

at any time. 

ADDRESSES: Submit written requests for 

single copies of the guidance to the 

Communications Staff (HFV–12), Center 

for Veterinary Medicine, Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855. Send one selfaddressed adhesive label to assist that 

office in processing your request. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance 

document. 

Submit electronic comments on the 

revised guidance to http://

www.regulations.gov. Submit written 

comments on the guidance to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, Rm. 1061, Rockville, 

MD 20852. 

FOR FURTHER INFORMATION CONTACT: Julia 

Oriani, Center for Veterinary Medicine 

(HFV–151), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–402–0788, 

julia.oriani@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In recent years, many important 

initiatives have been undertaken by 

regulatory authorities and industry 

associations to promote the 

international harmonization of 

regulatory requirements. FDA has 

participated in efforts to enhance 

harmonization and has expressed its 

commitment to seek scientifically based 

harmonized technical procedures for the 

development of pharmaceutical 

products. One of the goals of 

harmonization is to identify, and then 

reduce, differences in technical 

requirements for drug development 

among regulatory agencies in different 

countries. 

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