Federal Register / Vol. 77, No. 80 / Wednesday, April 25, 2012 / Notices 24719 

pertinent scientific information on this 

device will improve the quality of this 

comparative effectiveness review. 

AHRQ is requesting this scientific 

information and conducting this 

comparative effectiveness review 

pursuant to Section 1013 of the 

Medicare Prescription Drug, 

Improvement, and Modernization Act of 

2003, Public Law 108–173. 

DATES: Submission Deadline on or 

before May 25, 2012. 

ADDRESSES: 

Online submissions: http://effective

healthcare.AHRQ.gov/index.cfm/ 

submit-scientific-information-packets/. 

Please select the study for which you 

are submitting information from the list 

of current studies and complete the 

form to upload your documents. 

Email submissions: ehcsrc@ohsu.edu 

(please do not send zipped files—they 

are automatically deleted for security 

reasons). 

Print submissions: Robin Paynter, 

Oregon Health and Science University, 

Oregon Evidence-based Practice Center, 

3181 SW Sam Jackson Park Road, Mail 

Code: BICC, Portland, OR 97239–3098. 

FOR FURTHER INFORMATION CONTACT: 

Robin Paynter, Research Librarian, 

Telephone: 503–494–0147 or Email: 

ehcsrc@ohsu.edu. 

SUPPLEMENTARY INFORMATION: In 

accordance with Section 1013 of the 

Medicare Prescription Drug, 

Improvement, and Modernization Act of 

2003, Public Law 108–173, the Agency 

for Healthcare Research and Quality has 

commissioned the Effective Health Care 

(EHC) Program Evidence-based Practice 

Centers to complete a comparative 

effectiveness review of the evidence for 

chronic venous ulcer treatment 

modalities. 

The EHC Program is dedicated to 

identifying as many studies as possible 

that are relevant to the questions for 

each of its reviews. In order to do so, we 

are supplementing the usual manual 

and electronic database searches of the 

literature by systematically requesting 

information (e.g., details of studies 

conducted) from medical device 

industry stakeholders through public 

information requests, including via the 

Federal Register and direct postal and/ 

or online solicitations. We are looking 

for studies that report on chronic 

venous ulcer treatments, including 

those that describe adverse events, as 

specified in the key questions detailed 

below. The entire research protocol, 

including the key questions, is also 

available online at: http://www.effective

healthcare.AHRQ.gov/index.cfm/ 

search-for-guides-reviews-and-reports/

?productid=995&pageaction=

displayproduct#4886 

This notice is a request for industry 

stakeholders to submit the following: 

• A current product label, if 

applicable (preferably an electronic PDF 

file). 

• Information identifying published 

randomized controlled trials and 

observational studies relevant to the 

clinical outcomes. Please provide both a 

list of citations and reprints if possible. 

• Information identifying 

unpublished randomized controlled 

trials and observational studies relevant 

to the clinical outcomes. If possible, 

please provide a summary that includes 

the following elements: Study number, 

study period, design, methodology, 

indication and diagnosis, proper use 

instructions, inclusion and exclusion 

criteria, primary and secondary 

outcomes, baseline characteristics, 

number of patients screened/eligible/ 

enrolled/lost to withdrawn/follow-up/ 

analyzed, and effectiveness/efficacy and 

safety results. 

• Registered ClinicalTrials.gov 

studies. Please provide a list including 

the ClinicalTrials.gov identifier, 

condition, and intervention. 

Your contribution is very beneficial to 

this program. AHRQ is not requesting 

and will not consider marketing 

material, health economics information, 

or information on other indications. 

This is a voluntary request for 

information, and all costs for complying 

with this request must be borne by the 

submitter. In addition to your scientific 

information please submit an index 

document outlining the relevant 

information in each file along with a 

statement regarding whether or not the 

submission comprises all of the 

complete information available. 

Please Note: The contents of all 

submissions, regardless of format, will be 

available to the public upon request unless 

prohibited by law. 

The draft of this review will be posted on 

AHRQ’s EHC program Web site and available 

for public comment for a period of 4 weeks. 

If you would like to be notified when the 

draft is posted, please sign up for the email 

list at: http://effectivehealthcare.AHRQ.gov/

index.cfm/join-the-email-list1/. 

The Key Questions 

Question 1 

For patients with chronic venous leg 

ulcers, what are the benefits and harms 

of using dressings that regulate wound 

moisture with or without active 

chemical, enzymatic, biologic, or 

antimicrobial components in 

conjunction with compression systems 

when compared with using solely 

compression systems? 

Question 2 

a. For patients with chronic venous 

leg ulcers that do not have clinical signs 

of cellulitis that are being treated with 

compression systems, what are the 

benefits and harms of using systemic 

antibiotics when compared with using 

solely compression systems? 

b. For patients with chronic venous 

leg ulcers that do not have clinical signs 

of cellulitis that are being treated with 

dressings that regulate wound moisture 

with or without active chemical, 

enzymatic, biologic, or antimicrobial 

components, what are the benefits and 

harms of using systemic antibiotics 

when compared with using dressings 

alone? 

Question 3 

a. For patients with chronic venous 

leg ulcers, what are the benefits and 

harms of surgical procedures aimed at 

the underlying venous abnormalities 

when compared with using solely 

compression systems? 

b. For patients with chronic venous 

leg ulcers, what are the comparative 

benefits and harms of different surgical 

procedures for a given type of venous 

reflux and obstruction? 

Dated: April 12, 2012. 

Carolyn M. Clancy, 

AHRQ, Director. 

[FR Doc. 2012–9820 Filed 4–24–12; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Disease, Disability, and Injury 

Prevention and Control Special 

Emphasis Panel (SEP): Secondary 

Review 

The meeting announced below 

concerns Grants for Injury Control 

Research Centers, Funding Opportunity 

Announcement (FOA) CE12–001, 

secondary review. 

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

the Federal Advisory Committee Act 

(Pub. L. 92–463), the Centers for Disease 

Control and Prevention (CDC) 

announces the aforementioned SEP: 

Time and Date: 1 p.m.–3 p.m., May 31, 

2012 (Closed). 

Place: Teleconference. 

Status: The meeting will be closed to the 

public in accordance with provisions set 

forth in Section 552b(c) (4) and (6), Title 5 

U.S.C., and the Determination of the Director, 

Management Analysis and Services Office, 

CDC, pursuant to Public Law 92–463. 

Matters To Be Discussed: The meeting will 

include the secondary review and discussion 


pmangrum on DSK3VPTVN1PROD with NOTICES
24720 Federal Register / Vol. 77, No. 80 / Wednesday, April 25, 2012 / Notices 

of competitive applications following initial 

review of applications received in response 

to ‘‘FOA CE12–001, Grants for Injury Control 

Research Centers (R49).’’ 

Contact Person for More Information: 

Christine Morrison, Ph.D., Director, 

Extramural Research Program Office, 

National Center for Injury Prevention and 

Control, CDC, 4770 Buford Highway, NE., 

Mailstop F63, Atlanta, Georgia 30341–3724, 

Telephone (770) 488–4233. 

The Director, Management Analysis and 

Services Office, has been delegated the 

authority to sign Federal Register notices 

pertaining to announcements of meetings and 

other committee management activities, for 

both the Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Dated: April 18, 2012. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. 2012–9935 Filed 4–24–12; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Board of Scientific Counselors, 

National Center for Environmental 

Health/Agency for Toxic Substances 

and Disease Registry (BSC, NCEH/ 

ATSDR) 

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

the Federal Advisory Committee Act 

(Pub. L. 92–463), the Centers for Disease 

Control and Prevention (CDC), 

announces the following meeting of the 

aforementioned committee: 

Times and Dates: 8:30 a.m.–4:30 p.m., May 

17, 2012. 8:30 a.m.–12:15 p.m., May 18, 2012. 

Place: CDC, 4770 Buford Highway, Atlanta, 

Georgia 30341. 

Status: Open to the public, limited only by 

the space available. The meeting room 

accommodates approximately 75 people. 

Purpose: The Secretary, Department of 

Health and Human Services (HHS) and by 

delegation, the Director, CDC and 

Administrator, NCEH/ATSDR, are authorized 

under Section 301 (42 U.S.C. 241) and 

Section 311 (42 U.S.C. 243) of the Public 

Health Service Act, as amended, to: (1) 

Conduct, encourage, cooperate with, and 

assist other appropriate public authorities, 

scientific institutions, and scientists in the 

conduct of research, investigations, 

experiments, demonstrations, and studies 

relating to the causes, diagnosis, treatment, 

control, and prevention of physical and 

mental diseases and other impairments; (2) 

assist states and their political subdivisions 

in the prevention of infectious diseases and 

other preventable conditions and in the 

promotion of health and well being; and (3) 

train state and local personnel in health 

work. The BSC, NCEH/ATSDR provides 

advice and guidance to the Secretary, HHS; 

the Director, CDC and Administrator, 

ATSDR; and the Director, NCEH/ATSDR, 

regarding program goals, objectives, 

strategies, and priorities in fulfillment of the 

agency’s mission to protect and promote 

people’s health. The board provides advice 

and guidance that will assist NCEH/ATSDR 

in ensuring scientific quality, timeliness, 

utility, and dissemination of results. The 

board also provides guidance to help NCEH/ 

ATSDR work more efficiently and effectively 

with its various constituents and to fulfill its 

mission in protecting America’s health. 

Matters to be Discussed: The agenda items 

for the BSC Meeting on May 17–18, 2012 will 

include NCEH/ATSDR Office of the Director 

updates: ATSDR and NCEH Reorganization; 

update on the Nutritional Biomarker Report: 

Transfat analysis; ATSDR Science 

Symposium recommendations; presentation 

on Environmental Health Exposure 

Investigations; update on the Advisory 

Committee on Childhood Lead Poisoning 

Prevention; and updates by the BSC Federal 

Experts. 

Agenda items are subject to change as 

priorities dictate. 

Supplementary Information: The public 

comment period is scheduled on Thursday, 

May 17, 2012 from 3 p.m. until 3:15 p.m., 

and Friday, May 18, 2012 from 10:45 a.m. 

until 11 a.m. 

Contact Person for More Information: 

Sandra Malcom, Committee Management 

Specialist, NCEH/ATSDR, 4770 Buford 

Highway, Mail Stop F–61, Chamblee, Georgia 

30345; telephone (770) 488–0575, Fax: (770) 

488–3377; email: smalcom@cdc.gov. The 

deadline for notification of attendance is May 

11, 2012. 

The Director, Management Analysis and 

Services Office, has been delegated the 

authority to sign Federal Register notices 

pertaining to announcements of meetings and 

other committee management activities for 

both the Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Dated: April 18, 2012. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. 2012–9925 Filed 4–24–12; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Disease, Disability, and Injury 

Prevention and Control Special 

Emphasis Panel (SEP): Initial Review 

The meeting announced below 

concerns Conducting Operational 

Research to Measure or Mitigate 

Morbidity and Mortality of Populations 

Affected by Humanitarian Emergencies, 

Funding Opportunity Announcement 

(FOA) GH12–007, initial review. 

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

the Federal Advisory Committee Act 

(Pub. L. 92–463), the Centers for Disease 

Control and Prevention (CDC) 

announces the aforementioned meeting: 

DATES: Time and Date: 1 p.m.–4 p.m., 

June 20, 2012 (Closed). 

PLACE: Teleconference. 

STATUS: The meeting will be closed to 

the public in accordance with 

provisions set forth in Section 

552b(c)(4) and (6), Title 5 U.S.C., and 

the Determination of the Director, 

Management Analysis and Services 

Office, CDC, pursuant to Public Law 92– 

463. 

MATTERS TO BE DISCUSSED: The meeting 

will include the initial review, 

discussion, and evaluation of 

applications received in response to 

‘‘Conducting Operational Research to 

Measure or Mitigate Morbidity and 

Mortality of Populations Affected by 

Humanitarian Emergencies, FOA GH12– 

007.’’ 

CONTACT PERSON FOR MORE INFORMATION: 

Diana Bartlett, Scientific Review Officer, 

Office of the Associate Director for 

Science, Office of Science Quality, CDC, 

1600 Clifton Road NE., Mailstop D–72, 

Atlanta, Georgia 30033, Telephone (404) 

639–4938. 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

management activities, for both the 

Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Dated: April 25, 2012. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. 2012–9924 Filed 4–24–12; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0827] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Revisions to 

Labeling Requirements for Blood and 

Blood Components, Including Source 

Plasma 

AGENCY: Food and Drug Administration, 

HHS. 


pmangrum on DSK3VPTVN1PROD with NOTICES