Federal Register / Vol. 80, No. 46 / Tuesday, March 10, 2015 / Notices 12643 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Reclassification Petitions for Medical 

Devices—21 CFR 860.123 (OMB Control 

Number 0910–0138)—Extension 

Under sections 513(e) and (f), 514(b), 

515(b), and 520(l) of the Federal Food, 

Drug, and Cosmetic Act (FD&C Act) (21 

U.S.C. 360c(e) and (f), 360d(b), 360e(b), 

and 360j(l)) and part 860 (21 CFR part 

860), subpart C, FDA has responsibility 

to collect data and information 

contained in reclassification petitions. 

The reclassification provisions of the 

FD&C Act allow any person to petition 

for reclassification of a device from any 

of the three classes, i.e., I, II, and III, to 

another class. The reclassification 

content regulation (§ 860.123) requires 

the submission of valid scientific 

evidence demonstrating that the 

proposed reclassification will provide a 

reasonable assurance of safety and 

effectiveness of the device type for its 

indications for use. 

The reclassification procedure 

regulation requires the submission of 

specific data when a manufacturer is 

petitioning for reclassification. This 

includes a ‘‘Supplemental Data Sheet,’’ 

Form FDA 3427, and a ‘‘General Device 

Classification Questionnaire,’’ Form 

FDA 3429. Both forms contain a series 

of questions concerning the safety and 

effectiveness of the device type. 

In the Federal Register of March 25, 

2014 (79 FR 16252), FDA issued a 

proposed rule that would eliminate the 

need for Forms FDA 3427 and FDA 

3429. However, because the proposed 

rule has not been finalized, we continue 

to include the forms in the burden 

estimate for this information collection. 

The reclassification provisions of the 

FD&C Act serve primarily as a vehicle 

for manufacturers to seek 

reclassification from a higher to a lower 

class, thereby reducing the regulatory 

requirements applicable to a particular 

device type, or to seek reclassification 

from a lower to a higher class, thereby 

increasing the regulatory requirements 

applicable to that device type. If 

approved, petitions requesting 

classification from class III to class II or 

class I provide an alternative route to 

market in lieu of premarket approval for 

class III devices. If approved, petitions 

requesting reclassification from class I 

or II, to a different class, may increase 

requirements. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity FDA Form 

Nos. 

Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Supporting data for reclassification petition ........................................................ ........................ 6 1 6 497 2,982 

Supplemental Data Sheet ........................ 3427 6 1 6 1.5 9 

General Device Classification Questionnaire ...................................................... 3429 6 1 6 1.5 9 

Total .................................................. ........................ ........................ ........................ ........................ ........................ 3,000 

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

Based on reclassification petitions 

received in the last 3 years, FDA 

anticipates that six petitions will be 

submitted each year. The time required 

to prepare and submit a reclassification 

petition, including the time needed to 

assemble supporting data, averages 500 

hours per petition. This average is based 

upon estimates by FDA administrative 

and technical staff who: (1) Are familiar 

with the requirements for submission of 

a reclassification petition, (2) have 

consulted and advised manufacturers on 

these requirements, and (3) have 

reviewed the documentation submitted. 

This document refers to previously 

approved collections of information 

found in FDA regulations. These 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). The collections of information in 

21 CFR part 807, subpart E have been 

approved under OMB control number 

0910–0120 and the collections of 

information in 21 CFR part 814, 

subparts A through E have been 

approved under OMB control number 

0910–0231. 

Dated: March 4, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–05506 Filed 3–9–15; 8:45 am] 

BILLING CODE 4164–01–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 (5 U.S.C. App.), 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, 

mstockstill on DSK4VPTVN1PROD with NOTICES

12644 Federal Register / Vol. 80, No. 46 / Tuesday, March 10, 2015 / Notices 

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 Special Emphasis Panel; Member 

Conflict SEP. 

Date: March 26, 2015. 

Time: 11:00 a.m. to 12:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute on Aging, 

Gateway Building, Suite 2C212, 7201 

Wisconsin Avenue, Bethesda, MD 20892, 

(Telephone Conference Call). 

Contact Person: Ramesh Vemuri, Ph.D., 

Chief, Scientific Review Branch, National 

Institute On Aging, National Institutes Of 

Health, 7201 Wisconsin Avenue, Suite 2C– 

212, Bethesda, MD 20892, 301–402–7700, 

rv23r@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.866, Aging Research, 

National Institutes of Health, HHS) 

Dated: March 4, 2015. 

Melanie J. Gray, 

Program Analyst Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2015–05454 Filed 3–9–15; 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 Meeting 

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 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 of 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel; Ancillary R01 

Telephone Review SEP. 

Date: April 3, 2015. 

Time: 1:00 p.m. to 2:00 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: Xiaodu Guo, Md, Ph.D., 

Scientific Review Officer, Review Branch, 

DEA, NIDDK, National Institutes of Health, 

Room 761, 6707 Democracy Boulevard, 

Bethesda, MD 20892–5452, (301) 594–4719, 

guox@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 4, 2015. 

David Clary, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2015–05509 Filed 3–9–15; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Office of the Director, National 

Institutes of Health Notice of Meeting 

Pursuant to section 10(a) of the 

Federal Advisory Committee Act, as 

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

hereby given of a meeting of the Office 

of AIDS Research Advisory Council. 

The meeting will be open to the 

public, with attendance 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 Contact Person listed below 

in advance of the meeting. 

Name of Committee: Office of AIDS 

Research Advisory Council. 

Date: April 16, 2015. 

Time: 8:30 a.m. to 5:00 p.m. 

Agenda: The next meeting of the Office of 

AIDS Research Advisory Council (OARAC) 

will be devoted to presentations and 

discussions on ‘‘Maximizing U.S. Agency 

Partnerships for International HIV/AIDS 

Research.’’ An update will be provided on 

the latest changes made to the federal 

treatment and prevention guidelines by the 

OARAC Working Groups responsible for the 

guidelines. 

Place: National Institutes of Health, 5635 

Fishers Lane Conference Center, Terrace 

Level, Suite T–500, Rockville, MD 20852. 

Contact Person: Amelia Hall, M.A., 

Program Analyst, Office of AIDS Research, 

Office of the Director, NIH, 5601 Fishers 

Lane, Room 2E63, Rockville, MD 20852, 

(240) 669–5462, hallam@mail.nih.gov. 

Any interested person may file written 

comments with the committee by forwarding 

the statement to the Contact Person listed on 

this notice. The statement should include the 

name, address, telephone number and when 

applicable, the business or professional 

affiliation. Information is also available on 

the OAR’s home page: http://

www.oar.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.14, Intramural Research 

Training Award; 93.22, Clinical Research 

Loan Repayment Program for Individuals 

from Disadvantaged Backgrounds; 93.232, 

Loan Repayment Program for Research 

Generally; 93.39, Academic Research 

Enhancement Award; 93.936, NIH Acquired 

Immunodeficiency Syndrome Research Loan 

Repayment Program; 93.187, Undergraduate 

Scholarship Program for Individuals from 

Disadvantaged Backgrounds, National 

Institutes of Health, HHS) 

Dated: March 4, 2015. 

Melanie J. Gray, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2015–05446 Filed 3–9–15; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30 Day–15–14BAA] 

Agency Forms Undergoing Paperwork 

Reduction Act Review 

The Centers for Disease Control and 

Prevention (CDC) has submitted the 

following information collection request 

to the Office of Management and Budget 

(OMB) for review and approval in 

accordance with the Paperwork 

Reduction Act of 1995. The notice for 

the proposed information collection is 

published to obtain comments from the 

public and affected agencies. 

Written comments and suggestions 

from the public and affected agencies 

concerning the proposed collection of 

information are encouraged. Your 

comments should address any of the 

following: (a) Evaluate whether the 

proposed collection of information is 

necessary for the proper performance of 

the functions of the agency, including 

whether the information will have 

practical utility; (b) Evaluate the 

accuracy of the agencies estimate of the 

burden of the proposed collection of 

information, including the validity of 

the methodology and assumptions used; 

(c) Enhance the quality, utility, and 

clarity of the information to be 

collected; (d) Minimize the burden of 

the collection of information on those 

who are to respond, including through 

the use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology, 

e.g., permitting electronic submission of 

responses; and (e) Assess information 

collection costs. 

To request additional information on 

the proposed project or to obtain a copy 

mstockstill on DSK4VPTVN1PROD with NOTICES