52244 Federal Register / Vol. 74, No. 195 / Friday, October 9, 2009 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0118] 

Guidances for Industry and Food and 

Drug Administration Staff; Class II 

Special Controls Guidance 

Documents: Respiratory Viral Panel 

Multiplex Nucleic Acid Assay; and 

Testing for Human Metapneumovirus 

Using Nucleic Acid Assays; and 

Testing for Detection and 

Differentiation of Influenza A Virus 

Subtypes Using Multiplex Nucleic Acid 

Assays; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the special controls 

guidance document entitled ‘‘Class II 

Special Controls Guidance Document: 

Respiratory Viral Panel Multiplex 

Nucleic Acid Assay,’’ and two 

companion special controls guidance 

documents entitled ‘‘Class II Special 

Controls Guidance Document: Testing 

for Human Metapneumovirus (hMPV) 

Using Nucleic Acid Assays’’ and ‘‘Class 

II Special Controls Guidance Document: 

Testing for Detection and Differentiation 

of Influenza A Virus Subtypes Using 

Multiplex Nucleic Acid Assays.’’ These 

guidance documents describe a means 

by which respiratory viral panel 

multiplex nucleic acid assays may 

comply with the requirement of special 

controls for class II devices. The 

guidance documents include 

recommendations for performance 

evaluation, labeling, and measures to 

address the effects of ancillary reagents 

(specific reagents required under 

instructions for use of the assay but not 

provided) on safety and effectiveness of 

the device. Elsewhere in this issue of 

the Federal Register, FDA is publishing 

a final rule codifying the classification 

of the respiratory viral panel multiplex 

nucleic acid assay into class II (special 

controls), and establishing these 

guidance documents as the special 

controls for those devices. 

DATES: Submit written or electronic 

comments on the guidances at any time. 

General comments on agency guidance 

documents are welcome at any time. 

ADDRESSES: Submit written requests for 

single copies of the guidance documents 

entitled ‘‘Class II Special Controls 

Guidance Document: Respiratory Viral 

Panel Multiplex Nucleic Acid Assay,’’ 

‘‘Class II Special Controls Guidance 

Document: Testing for Human 

Metapneumovirus (hMPV) Using 

Nucleic Acid Assays,’’ or ‘‘Class II 

Special Controls Guidance Document: 

Testing for Detection and Differentiation 

of Influenza A Virus Subtypes Using 

Multiplex Nucleic Acid Assay’’ to the 

Division of Small Manufacturers, 

International, and Consumer Assistance, 

Center for Devices and Radiological 

Health, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 66, 

rm. 4613, Silver Spring, MD 20993. 

Send one self-addressed adhesive label 

to assist that office in processing your 

request, or fax your request to 301–847– 

8149. See the SUPPLEMENTARY

INFORMATION section for information on 

electronic access to the guidance. 

Submit written comments concerning 

these guidances to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

Submit electronic comments to http:// 

www.regulations.gov. Identify 

comments with the docket number 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Zivana Tezak, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, rm. 5550, Silver Spring, 

MD 20993, 301–796–6204. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Elsewhere in this issue of the Federal 

Register, FDA is publishing a final rule 

codifying the classification of the 

respiratory viral panel multiplex nucleic 

acid assay into class II (special controls) 

under section 513(f)(2) of the Federal 

Food, Drug, and Cosmetic Act (the act) 

(21 U.S.C. 360c(f)(2)), and establishing 

these guidance documents as the special 

controls for respiratory viral panel 

multiplex nucleic acid assay devices 

classified under that regulation. Section 

513(f)(2) of the act provides that any 

person who submits a premarket 

notification under section 510(k) of the 

act (21 U.S.C. 360(k)) for a device that 

has not previously been classified may, 

within 30 days after receiving an order 

classifying the device in class III under 

section 513(f)(1), request FDA to classify 

the device under the criteria set forth in 

section 513(a)(1). FDA shall, within 60 

days of receiving such a request, classify 

the device by written order. This 

classification shall be the initial 

classification of the device. Within 30 

days after the issuance of an order 

classifying the device, FDA must 

publish a notice in the Federal Register 

announcing such classification. 

Under this authority, on January 3, 

2008, FDA by order classified into class 

II, subject to these special control 

guidance documents, the Luminex 

Molecular Diagnostics, Inc., xTAGTM

RVP (Respiratory Viral Panel). 

II. Significance of Special Controls 

Guidance Documents 

FDA believes that adherence to the 

recommendations described in these 

guidance documents, in addition to the 

general controls, will provide 

reasonable assurance of the safety and 

effectiveness of respiratory viral panel 

multiplex nucleic acid assays classified 

under § 866.3080. In order to be 

classified as a class II device under 

§ 866.3080, an RVP device must comply 

with the requirement of special controls; 

manufacturers must address the issues 

requiring special controls as identified 

in the guidance documents, either by 

following the recommendations in the 

guidance documents or by some other 

means that provides equivalent 

assurances of safety and effectiveness. 

III. Electronic Access 

Persons interested in obtaining a copy 

of any of the guidance documents may 

do so by using the Internet. To receive 

‘‘Class II Special Controls Guidance 

Document: Respiratory Viral Panel 

Multiplex Nucleic Acid Assay,’’ 

(document number 1669); ‘‘Class II 

Special Controls Guidance Document: 

Testing for Human Metapneumovirus 

(hMPV) Using Nucleic Acid Assays,’’ 

(document number 1673); or ‘‘Class II 

Special Controls Guidance Document: 

Testing for Detection and Differentiation 

of Influenza A Virus Subtypes Using 

Multiplex Nucleic Acid Assays,’’ 

(document number 1672); you may 

either send an e-mail request to 

dsmica@fda.hhs.gov to receive an 

electronic copy of the document, or 

send a fax request to 301–847–8149 to 

receive a hard copy. Please use the 

document numbers shown in 

parentheses in the previous sentence to 

identify the guidance you are 

requesting. 

CDRH maintains an entry on the 

Internet for easy access to information 

including text, graphics, and files that 

may be downloaded to a personal 

computer with Internet access. Updated 

on a regular basis, the CDRH home page 

includes device safety alerts, Federal 

Register reprints, information on 

premarket submissions (including lists 

of approved applications and 

manufacturers’ addresses), small 

manufacturer’s assistance, information 

on video conferencing and electronic 

submissions, Mammography Matters, 

and other device-oriented information. 

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Federal Register / Vol. 74, No. 195 / Friday, October 9, 2009 / Notices 52245 

The CDRH Web site may be accessed at 

http://www.fda.gov/MedicalDevices/ 

default.htm. A search capability for all 

CDRH guidance documents is available 

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

DeviceRegulationandGuidance/ 

GuidanceDocuments/default.htm. 

Guidance documents are also available 

on the Division of Dockets Management 

Internet site at http:// 

www.regulations.gov. 

IV. Paperwork Reduction Act of 1995 

Elsewhere in this issue of the Federal 

Register, FDA is publishing a final rule 

establishing as special controls for the 

respiratory viral panel multiplex nucleic 

acid assay the three guidance 

documents that are the subject of this 

notice. The preamble to that rule 

addresses the application of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501–3520) to the information 

collection provisions referenced in these 

guidance documents. 

V. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified with the 

docket number found in brackets in the 

heading of this document. Revised 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Dated: October 1, 2009. 

Jeffrey Shuren, 

Acting Director, Center for Devices and 

Radiological Health. 

[FR Doc. E9–24431 Filed 10–8–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; 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: Center for Scientific 

Review Special Emphasis Panel; Molecular, 

Cellular and Developmental Neurobiological 

Small Business. 

Date: November 16–17, 2009. 

Time: 8 a.m. to 6 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892. 

(Virtual Meeting) 

Contact Person: Eugene Carstea, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5199, 

MSC 7846, Bethesda, MD 20892, (301) 435– 

0634. 

Name of Committee: AIDS and Related 

Research Integrated Review Group; 

Behavioral and Social Consequences of HIV/ 

AIDS Study Section. 

Date: November 16–17, 2009. 

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

Agenda: To review and evaluate grant 

applications. 

Place: Palomar Hotel, 2121 P Street, NW., 

Washington, DC 20037. 

Contact Person: Mark P. Rubert, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5218, 

MSC 7852, Bethesda, MD 20892, 301–435– 

1775, rubertm@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Small 

Business: Developmental Biology and Aging. 

Date: November 16, 2009. 

Time: 8 a.m. to 6 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Ritz-Carlton Hotel, 1150 22nd Street, 

NW., Washington, DC 20037. 

Contact Person: Joseph G. Rudolph, PhD, 

Chief and Scientific Review Officer, Center 

for Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5186, 

MSC 7844, Bethesda, MD 20892, 301–435– 

2212, josephru@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; RFA–OD– 

09–008 BRDG–SPAN and RFA–OD–09–009 

Catalyst ARRA Review Panel #1. 

Date: November 16, 2009. 

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

Agenda: To review and evaluate grant 

applications. 

Place: Hotel Monaco, 700 F Street, NW., 

Washington, DC 20001. 

Contact Person: David Balasundaram, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5189, 

MSC 7840, Bethesda, MD 20892, 301–435– 

1022, balasundaramd@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Infectious 

Diseases and Microbiology Fellowships. 

Date: November 16–17, 2009. 

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

Agenda: To review and evaluate grant 

applications. 

Place: Beacon Hotel and Corporate 

Quarters, 1615 Rhode Island Avenue, NW., 

Washington, DC 20036. 

Contact Person: Alexander D. Politis, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3210, 

MSC 7808, Bethesda, MD 20892, (301) 435– 

1150, politisa@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: Musculoskeletal Rehabilitation. 

Date: November 16, 2009. 

Time: 11 a.m. to 1 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892. 

(Telephone Conference Call) 

Contact Person: Aftab A. Ansari, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4108, 

MSC 7814, Bethesda, MD 20892, 301–594– 

6376, ansaria@csr.nih.gov. 

Name of Committee: AIDS and Related 

Research Integrated Review Group; AIDS 

Clinical Studies and Epidemiology Study 

Section. 

Date: November 17–18, 2009. 

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

Agenda: To review and evaluate grant 

applications. 

Place: The Fairmont Washington, DC, 2401 

M Street, NW., Washington, DC 20037. 

Contact Person: Hilary D. Sigmon, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5222, 

MSC 7852, Bethesda, MD 20892, (301) 594– 

6377, sigmonh@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; RFA–OD– 

09–008 BRDG–SPAN and RFA–OD–09–009, 

Catalyst ARRA Review Panel #5. 

Date: November 17, 2009. 

Time: 8 a.m. to 6 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Bethesda North Marriott Hotel & 

Conference Center, 5701 Marinelli Road, 

Bethesda, MD 20852. 

Contact Person: Mary Custer, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4148, 

MSC 7850, Bethesda, MD 20892, (301) 435– 

1164, custerm@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Orthopedic 

and Skeletal Biology SBIR/STTR. 

Date: November 17, 2009. 

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

Agenda: To review and evaluate grant 

applications. 

Place: Courtyard by Marriott 

Washingtonian Center, 204 Boardwalk Place, 

Gaithersburg, MD 20878. 

Contact Person: Kan Ma, PhD, Scientific 

Review Officer, National Institute of 

Arthritis, Musculoskeletal Scientific Review 

Branch, One Democracy Plaza Suite 800, 

Bethesda, MD 20892–4872, 301–451–4838, 

mak2@mail.nih.gov. 

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