Federal Register / Vol. 75, No. 85 / Tuesday, May 4, 2010 / Notices 23781 

Dated: April 28, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–10361 Filed 5–3–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0199] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Administrative 

Procedures for the Clinical Laboratory 

Improvement Amendments of 1988 

Categorization 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

administrative procedures for the 

Clinical Laboratory Improvement 

Amendments of 1988 (CLIA) 

categorization. 

DATES: Submit written or electronic 

comments on the collection of 

information by July 6, 2010. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Daniel Gittleson, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

5156, Daniel.Gittleson@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 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 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. 

Administrative Procedures for CLIA 

Categorization—42 CFR 493.17 (OMB 

Control Number 0910–0607–Extension) 

A guidance document entitled 

‘‘Guidance for Administrative 

Procedures for CLIA Categorization’’ was 

released on May 7, 2008. The document 

describes procedures FDA will use to 

assign the complexity category to a 

device. Typically, FDA assigns 

complexity categorizations to devices at 

the time of clearance or approval of the 

device. In this way, no additional 

burden is incurred by the manufacturer 

since the labeling (including operating 

instructions) is included in the 510(k) or 

PMA. In some cases, however, a 

manufacturer may request CLIA 

categorization even if FDA is not 

simultaneously reviewing a 510(k) or 

PMA. One example is when a 

manufacturer requests that FDA assign 

CLIA categorization to a previously 

cleared device that has changed names 

since the original CLIA categorization. 

Another example is when a device is 

exempt from premarket review. In such 

cases, the guidance recommends that 

manufacturers provide FDA with a copy 

of the package insert for the device and 

a cover letter indicating why the 

manufacturer is requesting a 

categorization (e.g. name change, 

exempt from 510(k) review). The 

guidance recommends that in the 

correspondence to FDA the 

manufacturer should identify the 

product code and classification as well 

as reference to the original 510(k) when 

this is available. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

CFR 

Section 

No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Responses Total Hours Total Operating & Maintenance Costs 

42 CFR 493.17 60 15 900 1 hr 900 hr $46,800 

1There are no capital costs associated with this collection of information. 

The number of respondents is 

approximately 60. On average, each 

respondent will request categorizations 

(independent of a 510(k) or PMA) 15 

times per year. The cost, not including 

personnel, is estimated at $52 per hour 

(52 x 900) totaling $46,800. This 

includes the cost of copying and mailing 

copies of package inserts and a cover 

letter, which includes a statement of the 

reason for the request and reference to 

the original 510(k) numbers, including 

regulation numbers and product codes. 

The burden hours are based on FDA 

familiarity with the types of 

documentation typically included in a 

sponsor’s categorization requests, and 

costs for basic office supplies (e.g. 

paper). The costs have been updated 

based on the Bureau of Labor Statistics 

estimates of inflation. 

mstockstill on DSKH9S0YB1PROD with NOTICES

23782 Federal Register / Vol. 75, No. 85 / Tuesday, May 4, 2010 / Notices 

Dated: April 28, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–10358 Filed 5–3–10; 8:45 am] 

BILLING CODE 4160–01–S 

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 

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; Bariatric Surgery 

and Kidney Function. 

Date: June 8, 2010. 

Time: 2 p.m. to 4 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: D.G. Patel, PhD, Scientific 

Review Officer, Review Branch, DEA, 

NIDDK, National Institutes of Health, Room 

756, 6707 Democracy Boulevard, Bethesda, 

MD 20892–5452, (301) 594–7682, 

pateldg@niddk.nih.gov. 

Name of Committee: National Institute of 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel; Collaborative 

Interdisciplinary. 

Date: June 11, 2010. 

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

Agenda: To review and evaluate grant 

applications and/or proposals. 

Place: National Institutes of Health, Two 

Democracy Plaza, 6707 Democracy 

Boulevard, Bethesda, MD 20892 (Telephone 

Conference Call). 

Contact Person: D.G. Patel, PhD, Scientific 

Review Officer, Review Branch, DEA, 

NIDDK, National Institutes of Health, Room 

756, 6707 Democracy Boulevard, Bethesda, 

MD 20892–5452, (301) 594–7682, 

pateldg@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: April 27, 2010. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–10268 Filed 5–3–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0001] 

Drug Safety and Risk Management 

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: Drug Safety and 

Risk Management 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 September 14, 2010, from 8 a.m. 

to 5 p.m. 

Location: The Marriott Inn and 

Conference Center, University of 

Maryland and University College 

(UMUC), The Ballrooms, 3501 

University Blvd. East, Adelphi, MD. The 

conference center telephone number is 

301–985–7300. 

Contact Person: Elaine Ferguson, email: elaine.ferguson@fda.hhs.gov 

(contact information through June 8, 

2010, Elaine Ferguson c/o Melanie 

Whelan, Food and Drug Administration, 

10903 New Hampshire Ave., WO51– 

6100, Silver Spring, MD 20993–0002, 

telephone: 301–827–7001, FAX: 301– 

847–8742), (contact information 

beginning June 9, 2010: Elaine Ferguson 

c/o Christine Shipe, Food and Drug 

Administration, 10903 New Hampshire 

Ave., WO31–2419, Silver Spring, MD 

20993–0002, telephone: 301–0796– 

9001, FAX: 301–847–8532), or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area), code 

3014512535. Please call the Information 

Line for up-to-date information on this 

meeting. 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 and call the appropriate advisory 

committee hot line/phone line to learn 

about possible modifications before 

coming to the meeting. 

Agenda: On September 14, 2010, the 

committee will discuss the abuse 

potential of the drug dextromethorphan 

and the public health benefits and risks 

of dextromethorphan use as a cough 

suppressant in prescription and 

nonprescription drug products. The 

Department of Health and Human 

Services received a request from the 

Drug Enforcement Administration for a 

scientific and medical evaluation and 

scheduling recommendation for 

dextromethorphan in response to the 

increased incidence of abuse, especially 

among adolescents. 

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 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 August 30, 2010. 

Oral presentations from the public will 

be scheduled between approximately 1 

p.m. to 2 p.m. Those desiring to make 

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 August 20, 2010. 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 August 23, 2010. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

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