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
Federal Register / Vol. 77, No. 80 / Wednesday, April 25, 2012 / Notices 24721 

1OCRA Student Rate applies to those individuals 

enrolled full time in a Regulatory or Quality related 

academic program at an accredited institution. 

Proof of enrollment is required. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by May 25, 

2012. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or emailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–New and 

title ‘‘Revisions to Labeling 

Requirements for Blood and Blood 

Components, Including Source Plasma.’’ 

Also include the FDA docket number 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: ≤Ila 

S. Mizrachi, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

7726, Ila.Mizrachi@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Revisions to Labeling Requirements for 

Blood and Blood Components, 

Including Source Plasma—(OMB 

Control Number 0910–NEW) 

FDA is finalizing the labeling 

requirements for blood or blood 

components intended for use in 

transfusion or for further manufacture 

under the provisions of the Public 

Health Service Act (PHS Act) (42 U.S.C. 

262–264), and the drugs, devices, and 

general administrative provisions of the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) (21 U.S.C. 321, 331, 351– 

353, 355, 360, 360j, 371, and 374). 

Under these provisions of the PHS Act 

and the FD&C Act, we have the 

authority to issue and enforce 

regulations designed to ensure that 

biological products are safe, pure, 

potent, and properly labeled, and to 

prevent the introduction, transmission, 

and spread of communicable disease. 

Under this rulemaking, FDA is 

consolidating the regulations related to 

labeling blood and blood components. 

Regulations for labeling of blood and 

blood components will be consolidated 

into § 606.121 (Container label) (21 CFR 

606.121) and § 606.122 (Circular of 

information) (21 CFR 606.122). This 

notice solicits comments on the 

information collection associated with 

§ 606.121(c)(11), which requires that if 

the product is intended for further 

manufacturing use, a statement listing 

the results of all the tests for 

communicable disease agents required 

under § 610.40 (21 CFR 610.40) for 

which the donation has been tested and 

found negative must be on the container 

label; except that the label for Source 

Plasma is not required to list the 

negative results of serological syphilis 

testing under § 610.40(i) and 21 CFR 

640.65(b). In addition, this notice also 

solicits comments on the information 

collection associated with 

§ 606.121(e)(2)(i), which requires that 

the product labels of certain red blood 

cells must include the type of additive 

solution with which the product was 

prepared. 

The Agency believes the rule 

amendments and the information 

collection provisions under 

§ 606.121(c)(11) and (e)(2)(i) in the final 

rule are part of usual and customary 

business practice and do not create any 

new burden for respondent. 

The collection of information 

requirements under §§ 606.121 and 

606.122 are approved under OMB 

control number 0910–0116 and those in 

21 CFR 640.70 have been approved 

under OMB control number 0910–0338. 

Under 5 CFR 1320.3(b)(2), the time, 

effort, and financial resources necessary 

to comply with a collection of 

information are excluded from the 

burden estimate if the reporting, 

recordkeeping, or disclosure activities 

needed to comply are usual and 

customary because they would occur in 

the normal course of activities. 

In the Federal Register of December 

30, 2011 (76 FR 82300), FDA published 

a 60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

Dated: April 19, 2012. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2012–9894 Filed 4–24–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0001] 

The 15th Annual Food and Drug 

Administration—Orange County 

Regulatory Affairs Educational 

Conference in Irvine, CA; ‘‘Sustainable 

Regulatory Practices’’ 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of conference. 

The Food and Drug Administration 

(FDA) is announcing the following 

conference: The 15th Annual 

Educational Conference cosponsored 

with the Orange County Regulatory 

Affairs Discussion Group (OCRA). The 

conference is intended to provide the 

drug, device, biologics, and dietary 

supplement industries with an 

opportunity to interact with FDA 

reviewers and compliance officers from 

the Centers and District Offices, as well 

as other industry experts. The main 

focus of this interactive conference will 

be product approval, compliance, and 

risk management in the three medical 

product areas. Industry speakers, 

interactive Q & A, and workshop 

sessions will also be included to assure 

open exchange and dialogue on the 

relevant regulatory issues. 

Date and Time: The conference will 

be held on June 6 and 7, 2012, from 7:30 

a.m. to 5 p.m. 

Location: The conference will be held 

at the Irvine Marriott, 18000 Von 

Karman Ave., Irvine, CA 92612. 

Contact: Linda Hartley, Food and 

Drug Administration, 19701 Fairchild, 

Irvine, CA 92612, 949–608–4413, Fax: 

949–608–4417, or OCRA, Attention to 

Detail, 5319 University Dr., suite 641, 

Irvine, CA 92612, 949–387–9046, Fax: 

949–266–8461, Web site: www.ocradg.org. (FDA has verified the Web site 

address, but FDA is not responsible for 

any subsequent changes to the Web site 

after this document publishes in the 

Federal Register). 

Registration and Meeting Information: 

See OCRA Web site, www.ocra-dg.org. 

Contact Attention to Detail, 949–387– 

9046. 

Before May 8, 2012, registration fees 

are as follows: $675 for members, $725 

for non-members and $475 for FDA/ 

Government/Students.1 After May 8, 

2012, fees will be $725 for members, 

$775 for non-members, and $475 for 


pmangrum on DSK3VPTVN1PROD with NOTICES