Federal Register / Vol. 74, No. 198 / Thursday, October 15, 2009 / Notices 52969 

DEPARTMENT OF HEALTH AND 

HUMAN SERIVCES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0664] 

Advancing Clinical Development of 

Molecular and Other Diagnostic Tests 

for Respiratory Tract Infections; Notice 

of Public Workshop 

AGENCY: Food and Drug Administration. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

public workshop, co-sponsored with the 

Infectious Diseases Society of America 

(IDSA), regarding scientific issues in the 

development of molecular and other 

tests for the diagnosis of respiratory 

infections, entitled ‘‘Advancing Clinical 

Development of Molecular and Other 

Diagnostic Tests for Respiratory Tract 

Infections.’’ The purpose of the public 

workshop is to provide an opportunity 

to share information and perspectives 

with health care providers, academia, 

and industry on various aspects of 

diagnostic test development for 

respiratory infections. Topics for 

discussion will include the role of 

emerging diagnostic tests in promoting 

appropriate use of antibiotics by 

physicians, the use of novel diagnostic 

tests in the study of new drugs for 

respiratory infections, and the possible 

contribution of biomarkers in the 

approach to treatment of respiratory 

infections. 

Date and Time: The public workshop 

will be held on November 12, 2009, 

from 8 a.m. to 6 p.m. and on November 

13, 2009, from 8 a.m. to 4:30 p.m. 

Location: The public workshop will 

be held at the Hilton Washington DC 

North/Gaithersburg, The Ballrooms, 620 

Perry Pkwy., Gaithersburg, MD 20877. 

Seating is limited and available only on 

a first-come, first-served basis. 

Contact Person: Christine Kellerman, 

Center for Devices and Radiological 

Health, Food and Drug Administration, 

Office of In Vitro Diagnostic Devices, 

10903 New Hampshire Ave., Building 

66, rm. 5677, Silver Spring, MD 20993– 

0002, 301–796–5711. 

Registration: To register 

electronically, e-mail registration 

information (including: Name, title, firm 

name, address, telephone, and fax 

numbers) to Respdiagmtg@fda.hhs.gov 

by November 8, 2009. Persons without 

access to the Internet can call 301–796– 

5711 to register. Registration is free for 

the public workshop. Interested parties 

are encouraged to register early because 

space is limited. Seating will be 

available on a first-come, first-served 

basis. Persons needing a sign language 

interpreter or other special 

accommodations should notify 

Christine Kellerman (see Contact 

Person) at least 7 days in advance. 

Additional information is also available 

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

NewsEvents/WorkshopsConferences/ 

ucm181140.htm. 

SUPPLEMENTARY INFORMATION: 

I. Background 

New diagnostic technologies offer 

opportunities to guide the appropriate 

clinical use of anti-infective agents, 

facilitate the study of new anti-infective 

agents, and aid in tracking the spread of 

infectious diseases. To explore issues 

regarding the development and 

adoption of emerging diagnostic tests, 

FDA is announcing a public workshop, 

co-sponsored with IDSA to address 

scientific issues in the development of 

in vitro diagnostic tests for respiratory 

infections. 

II. Topics for Discussion at the Public 

Workshop 

Topics to be discussed at the 

workshop include: 

• Principles of clinical trial design 

and their application to studies of new 

diagnostics, or studies where new 

diagnostics and new drugs are 

investigated simultaneously; 

• Test characteristics for emerging 

tests that would promote clinical 

adoption and improve antibiotic 

stewardship; 

• Principles for including specific 

viral or bacterial pathogens in multiplex 

diagnostic test panels; 

• Discussion of approaches to 

developing a new molecular method 

when there is no ‘‘gold standard’’ 

reference method; and 

• The use of biomarkers in respiratory 

infections. 

The input from this public workshop 

will help in developing topics for 

further discussion. The agency 

encourages individuals, patient 

advocates, industry, consumer groups, 

health care professionals, researchers, 

and other interested persons to attend 

this public workshop. 

Transcripts: Transcripts of the public 

workshop may be requested in writing 

from the Freedom of Information Office 

(HFI–35), Food and Drug 

Administration, 5600 Fishers Lane, rm. 

6–30, Rockville, MD 20857, 

approximately 20 working days after the 

public workshop at a cost of 10 cents 

per page. A link to the transcripts will 

also be available on the Internet at 

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

NewsEvents/WorkshopsConferences/ 

default.htm approximately 45 days after 

the workshop. 

Dated: October 7, 2009. 

Jeffrey Shuren, 

Acting Director, Center for Devices and 

Radiological Health. 

[FR Doc. E9–24828 Filed 10–14–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

[USCG–2009–0362] 

Collection of Information Under 

Review by Office of Management and 

Budget: OMB Control Numbers: 1625– 

0014, 1625–0038, and 1625–0069 

AGENCY: Coast Guard, DHS. 

ACTION: Thirty-day notice requesting 

comments. 

SUMMARY: In compliance with the 

Paperwork Reduction Act of 1995, this 

request for comments announces that 

the U.S. Coast Guard is forwarding three 

Information Collection Requests (ICRs), 

abstracted below, to the Office of 

Information and Regulatory Affairs 

(OIRA), Office of Management and 

Budget (OMB) requesting an extension 

of its approval for the following 

collections of information: (1) 1625– 

0014, Request for Designation and 

Exemption of Oceanographic Research 

Vessels; (2) 1625–0038, Plan Approval 

and Records for Tank, Passenger, Cargo 

and Miscellaneous Vessels, Mobile 

Offshore Drilling Units, Nautical School 

Vessels and Oceanographic Research 

Vessels—46 CFR Subchapters D, H, I, 

I–A, R and U; and (3) 1625–0069, Ballast 

Water Management for Vessels with 

Ballast Tanks Entering U.S. Waters. 

Review and comments by OIRA ensure 

we only impose paperwork burdens 

commensurate with our performance of 

duties. 

DATES: Please submit comments on or 

before November 16, 2009. 

ADDRESSES: You may submit comments 

identified by Coast Guard docket 

number [USCG–2009–0362] to the 

Docket Management Facility (DMF) at 

the U.S. Department of Transportation 

(DOT) or to OIRA. To avoid duplication, 

please submit your comments by only 

one of the following means: 

(1) Electronic submission. (a) To Coast 

Guard docket at http:// 

www.regulation.gov. (b) To OIRA by email via: oira_submission@omb.eop.gov. 

(2) Mail or Hand delivery. (a) DMF 

(M–30), DOT, West Building Ground 

Floor, Room W12–140, 1200 New Jersey 

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52970 Federal Register / Vol. 74, No. 198 / Thursday, October 15, 2009 / Notices 

Avenue, SE., Washington, DC 20590– 

0001. Hand deliver between the hours of 

9 a.m. and 5 p.m., Monday through 

Friday, except Federal holidays. The 

telephone number is 202–366–9329. (b) 

To OIRA, 725 17th Street, NW., 

Washington, DC 20503, attention Desk 

Officer for the Coast Guard. 

(3) Fax. (a) To DMF, 202–493–2251. 

(b) To OIRA at 202–395–5806. To 

ensure your comments are received in a 

timely manner, mark the fax, attention 

Desk Officer for the Coast Guard. 

The DMF maintains the public docket 

for this Notice. Comments and material 

received from the public, as well as 

documents mentioned in this Notice as 

being available in the docket, will 

become part of the docket and will be 

available for inspection or copying at 

Room W12–140 on the West Building 

Ground Floor, 1200 New Jersey Avenue, 

SE., Washington, DC, between 9 a.m. 

and 5 p.m., Monday through Friday, 

except Federal holidays. You may also 

find the docket on the Internet at http:// 

www.regulations.gov. 

Copies of the ICRs are available 

through the docket on the Internet at 

http://www.regulations.gov. 

Additionally, copies are available from: 

Commandant (CG–611), Attn: 

Paperwork Reduction Act Manager, U.S. 

Coast Guard, 2100 2nd St., SW., Stop 

7101, Washington, DC 20593–7101. 

FOR FURTHER INFORMATION: Contact Mr. 

Arthur Requina, Office of Information 

Management, telephone 202–475–3523 

or fax 202–475–3929, for questions on 

these documents. Contact Ms. Renee V. 

Wright, Program Manager, Docket 

Operations, 202–366–9826, for 

questions on the docket. 

SUPPLEMENTARY INFORMATION: 

The Coast Guard invites comments on 

whether these ICRs should be granted 

based on it being necessary for the 

proper performance of Departmental 

functions. In particular, the Coast Guard 

would appreciate comments addressing: 

(1) The practical utility of the 

collections; (2) the accuracy of the 

estimated burden of the collections; (3) 

ways to enhance the quality, utility, and 

clarity of information subject to the 

collections; and (4) ways to minimize 

the burden of collections on 

respondents, including the use of 

automated collection techniques or 

other forms of information technology. 

Comments to Coast Guard or OIRA 

must contain the OMB Control Number 

of the ICR. They must also contain the 

docket number of this request, [USCG 

2009–0362]. For your comments to 

OIRA to be considered, it is best if they 

are received on or before November 16, 

2009. 

Public participation and request for 

comments: We encourage you to 

respond to this request by submitting 

comments and related materials. We 

will post all comments received, 

without change, to http:// 

www.regulations.gov. They will include 

any personal information you provide. 

We have an agreement with DOT to use 

their DMF. Please see the ‘‘Privacy Act’’ 

paragraph below. 

Submitting comments: If you submit a 

comment, please include the docket 

number [USCG–2009–0362], indicate 

the specific section of the document to 

which each comment applies, providing 

a reason for each comment. We 

recommend you include your name, 

mailing address, an e-mail address, or 

other contact information in the body of 

your document so that we can contact 

you if we have questions regarding your 

submission. You may submit comments 

and material by electronic means, mail, 

fax, or delivery to the DMF at the 

address under ADDRESSES; but please 

submit them by only one means. If you 

submit them by mail or delivery, submit 

them in an unbound format, no larger 

than 81⁄2 by 11 inches, suitable for 

copying and electronic filing. If you 

submit them by mail and would like to 

know that they reached the Facility, 

please enclose a stamped, self-addressed 

postcard or envelope. In response to 

your comments, we may revise the ICR 

or decide not to seek an extension of 

approval for this collection. The Coast 

Guard and OIRA will consider all 

comments and material received during 

the comment period. 

Viewing comments and documents: 

Go to http://www.regulations.gov to 

view documents mentioned in this 

Notice as being available in the docket. 

Click on the ‘‘read comments’’ box, 

which will then become highlighted in 

blue. In the ‘‘Keyword’’ box insert 

‘‘USCG–2009–0362’’ and click 

‘‘Search.’’ Click the ‘‘Open Docket 

Folder’’ in the ‘‘Actions’’ column. You 

may also visit the DMF in room W12– 

140 on the West Building Ground Floor, 

1200 New Jersey Avenue, SE., 

Washington, DC, between 9 a.m. and 5 

p.m., Monday through Friday, except 

Federal holidays. 

Privacy Act: Anyone can search the 

electronic form of all comments 

received in dockets by the name of the 

individual submitting the comment (or 

signing the comment, if submitted on 

behalf of an association, business, labor 

union, etc.). You may review the 

Privacy Act statement regarding our 

public dockets in the January 17, 2008 

issue of the Federal Register (73 FR 

3316). 

Previous Request for Comments 

This request provides a 30-day 

comment period required by OIRA. The 

Coast Guard has published the 60-day 

notice (74 FR 26875, June 4, 2009) 

required by 44 U.S.C. 3506(c)(2). That 

Notice elicited no comments. 

Information Collection Request 

1. Title: Request for Designation and 

Exemption of Oceanographic Research 

Vessels. 

OMB Control Number: 1625–0014. 

Type of Request: Revision of a 

currently approved collection. 

Respondents: Owners/operators of 

vessels. 

Abstract: This information is 

necessary to ensure a vessel qualifies for 

the designation. 

Forms: None. 

Burden Estimate: The estimated 

burden has decreased from 51 hours to 

35 hours a year. 

2. Title: Plan Approval and Records 

for Tank, Passenger, Cargo and 

Miscellaneous Vessels, Mobile Offshore 

Drilling Units, Nautical School Vessels 

and Oceanographic Research Vessels— 

46 CFR Subchapters D, H, I, I–A, R and 

U. 

OMB Control Number: 1625–0038. 

Type of Request: Revision of a 

currently approved collection. 

Respondents: Shipyards, designers, 

and manufacturers of certain vessels. 

Abstract: Under 46 U.S.C. 3301 and 

3306, the Coast Guard is responsible for 

enforcing regulations promoting safety 

of life and property in marine 

transportation. The Coast Guard uses 

this information to ensure a vessel 

meets the applicable standards for 

construction, arrangement, and 

equipment. 

Forms: None. 

Burden Estimate: The estimated 

burden has decreased from 13,790 hours 

to 2,970 hours a year. 

3. Title: Ballast Water Management for 

Vessels with Ballast Tanks Entering U.S. 

Waters. 

OMB Control Number: 1625–0069. 

Type of Request: Revision of a 

currently approved collection. 

Respondents: Owners and operators 

of certain vessels. 

Abstract: The information is needed 

to ensure compliance with requirements 

in 33 CFR Part 151, Subparts C and D. 

The information will also be used for 

research and periodic reporting to 

Congress. 

Forms: CG–5662. 

Burden Estimate: The estimated 

burden has decreased from 60,769 hours 

to 60,727 hours a year. 

Authority: The Paperwork Reduction Act 

of 1995; 44 U.S.C. Chapter 35, as amended. 

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Federal Register / Vol. 74, No. 198 / Thursday, October 15, 2009 / Notices 52971 

Dated: October 7, 2009. 

M.B. Lytle, 

Captain, U.S. Coast Guard, Acting Assistant 

Commandant for Command, Control, 

Communications, Computers and 

Information Technology. 

[FR Doc. E9–24742 Filed 10–14–09; 8:45 am] 

BILLING CODE 4910–15–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

[Docket No. USCG–2009–0934] 

National Boating Safety Advisory 

Council 

AGENCY: Coast Guard, DHS. 

ACTION: Committee management; notice 

of meeting. 

SUMMARY: The National Boating Safety 

Advisory Council (NBSAC) and its 

subcommittees will meet on October 31 

and November 1 and 2, 2009, in 

Arlington, VA. The meetings will be 

open to the public. 

DATES: NBSAC will meet October 31, 

2009, from 9 a.m. to 12 p.m. and on 

November 2, 2009, from 9 a.m. to 5 p.m. 

The Boats and Associated Equipment 

Subcommittee will meet on October 31, 

from 1:30 p.m. to 2:45 p.m. The 

Prevention Through People 

Subcommittee will meet on October 31, 

2009, from 3 p.m. to 5 p.m., and the 

Recreational Boating Safety Strategic 

Planning Subcommittee will meet on 

November 1, 2009 from 9 a.m. to 5 p.m. 

Please note that the meetings may 

conclude early if the Council has 

completed its business. 

All written materials, comments, and 

requests to make oral presentations at 

the meetings should reach Mr. Jeff 

Ludwig by October 26, 2009, via one of 

the methods described in ADDRESSES. 

Requests to have a copy of your material 

distributed to each member of the 

Council prior to the meeting should 

reach Mr. Ludwig by October 26, 2009. 

ADDRESSES: The meeting will be held at 

the Holiday Inn Arlington, 4610 N 

Fairfax Drive, Arlington, VA 22203. 

Please send written material, 

comments, and requests to make oral 

presentations to Mr. Jeff Ludwig by one 

of the submission methods described 

below. All materials, comments, and 

requests must be identified by docket 

number USCG–2009–0934. 

Submission Methods: Please use only 

one of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• E-mail: jeffrey.a.ludwig@uscg.mil. 

Include the docket number (USCG– 

2009–0934) in the subject line of the 

message. 

• Fax: (202) 372–1932. 

• Mail: Mr. Jeff Ludwig, COMDT 

(CG–54221), 2100 2nd Street, SW., Stop 

7581, Washington, DC 20593. 

Instructions: All submissions received 

must include the words ‘‘U.S. Coast 

Guard’’ and docket number USCG– 

2009–0934. All submissions received 

will be posted without alteration at 

http://www.regulations.gov, including 

any personal information provided. 

Anyone can search the electronic form 

of comments received into any of our 

dockets by the name of the individual 

submitting the comment (or signing the 

comment, if submitted on behalf of an 

association, business, labor union, etc.) 

You may review a Privacy Act notice 

regarding our public dockets in the 

January 17, 2008 issue of the Federal 

Register (73 FR 3316). 

Docket: For access to the docket to 

read background documents or 

submissions received by the NBSAC, go 

to http://www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: Mr. 

Jeff Ludwig, COMDT (CG–54221), 2100 

2nd Street, SW., Stop 7581, Washington, 

DC 20593; (202) 372–1061; 

Jeffrey.a.ludwig@uscg.mil. 

SUPPLEMENTARY INFORMATION: Notice of 

this meeting is given under the Federal 

Advisory Committee Act, 5 U.S.C. App. 

(Pub. L. 92–463). NBSAC was 

established by the Federal Boat Safety 

Act of 1971. That law requires the 

Secretary of Homeland Security, and the 

Commandant of the Coast Guard by 

delegation, to consult with NBSAC in 

prescribing Federal regulations, and on 

other major matters regarding boating 

safety. See 46 U.S.C. 4302(c) and 

13110(c). 

NBSAC will meet for the purpose of 

discussing issues related to recreational 

boating safety. 

A. Tentative Agendas of Meetings 

National Boating Safety Advisory 

Council (NBSAC): 

Saturday, October 31, 2009: 

(1) Remarks—Mr. James P. Muldoon, 

NBSAC Chairman; 

(2) Chief, Office of Auxiliary and 

Boating Safety Update on NBSAC 

Resolutions and Recreational Boating 

Safety Program report. 

(3) Executive Secretary’s report. 

(4) Chairman’s session. 

(5) TSAC Liaison’s report. 

(6) NAVSAC Liaison’s report. 

(7) National Association of State 

Boating Law Administrators report. 

(8) Boats and Associated Equipment 

Subcommittee meeting. 

Sunday, November 1, 2009: 

(9) Prevention through People 

Subcommittee meeting. 

(10) Recreational Boating Safety 

Strategic Planning Subcommittee 

meeting. 

Monday, November 2, 2009: 

(11) Prevention through People 

Subcommittee report. 

(12) Boats and Associated Equipment 

Subcommittee report. 

(13) Recreational Boating Safety 

Strategic Planning Subcommittee report. 

A more detailed agenda can be found 

at: http://homeport.uscg.mil/NBSAC, 

after October 26, 2009. 

B. NBSAC Subcommittees 

Prevention Through People 

Subcommittee: Discuss current 

regulatory projects, grants, contracts, 

and new issues affecting the prevention 

of boating accidents through outreach 

and education of boaters. 

Boats and Associated Equipment 

Subcommittee: Discuss current 

regulatory projects, grants, contracts, 

and new issues affecting boats and 

associated equipment. 

Recreational Boating Safety Strategic 

Planning Subcommittee: Discuss current 

status of the strategic planning process 

and any new issues or factors that could 

impact, or contribute to, the 

development of the strategic plan for the 

recreational boating safety program. 

C. Meeting Procedure 

This meeting is open to the public. At 

the discretion of the Chair, members of 

the public may make oral presentations 

during the meeting. If you would like to 

make an oral presentation at the 

meeting, please notify Mr. Jeff Ludwig 

as described in the ADDRESSES section 

above. If you would like a copy of your 

material distributed to each member of 

the Council in advance of the meeting, 

please submit thirty (30) of copies to Mr. 

Jeff Ludwig by October 26, 2009. 

Please note that the meeting may 

conclude early if all business is 

finished. 

D. Information on Services for 

Individuals With Disabilities 

For information on facilities or 

services for individuals with disabilities 

or to request special assistance at the 

meeting, contact Mr. Jeff Ludwig as 

described in the ADDRESSES section 

above as soon as possible. 

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