21784 Federal Register / Vol. 77, No. 70 / Wednesday, April 11, 2012 / Notices 

Validation of Aseptic Preparations for 

Positron Emission Tomography (PET) 

Drugs.’’ Most PET drugs are designed for 

parenteral administration and are 

produced by aseptic processing. The 

goal of aseptic processing is to make a 

product that is free of microorganisms 

and toxic microbial byproducts, such as 

bacterial endotoxins. The media fill is 

the performance of an aseptic 

manufacturing procedure using a sterile 

microbiological growth medium in 

place of the drug solution to test 

whether the aseptic procedures are 

adequate to prevent contamination 

during actual drug production. This 

guidance takes the form of questions 

and answers written specifically to help 

manufacturers comply with the 

Agency’s current good manufacturing 

practices for PET drugs (21 CFR part 

212) regarding media fills. 

A draft guidance of the same title was 

announced in the Federal Register on 

September 30, 2011 (76 FR 60847), and 

Docket No. FDA 2011–D–0691 was open 

for comments until December 29, 2011. 

We received comments from industry 

and professional societies. We have 

carefully considered, and where 

appropriate, we have made corrections, 

added information, or clarified the 

information in this guidance in response 

to the comments or on our own 

initiative. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the Agency’s 

current thinking on media fills and 

process simulations for PET drugs. It 

does not create or confer any rights for 

or on any person and does not operate 

to bind FDA or the public. An 

alternative approach may be used if 

such approach satisfies the 

requirements of the applicable statutes 

and regulations. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. Identify comments with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

III. Paperwork Reduction Act of 1995 

This guidance refers to previously 

approved collections of information 

found in FDA regulations. These 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). The collections of information in 

21 CFR part 212 have been approved 

under OMB control number 0910–0667. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/

Guidances/default.htm or http:// 

www.regulations.gov. 

Dated: April 6, 2012. 

David Dorsey, 

Acting Associate Commissioner for Policy and 

Planning. 

[FR Doc. 2012–8702 Filed 4–10–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No FDA–2012–N–0001] 

Science Board to the Food and Drug 

Administration; 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: Science Board to 

the Food and Drug Administration 

(Science Board). 

General Function of the Committee: 

The Science Board provides advice 

primarily to the Commissioner of Food 

and Drugs and other appropriate 

officials on specific complex and 

technical issues, as well as emerging 

issues within the scientific community 

in industry and academia. Additionally, 

the Science Board provides advice to 

the Agency on keeping pace with 

technical and scientific evolutions in 

the fields of regulatory science, on 

formulating an appropriate research 

agenda, and on upgrading its scientific 

and research facilities to keep pace with 

these changes. It will also provide the 

means for critical review of Agencysponsored intramural and extramural 

scientific research programs. 

Date and Time: The meeting will be 

held on May 2, 2012, from 9 a.m. to 4 

p.m. 

Location: FDA White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31 

Conference Center, the Great Room (rm. 

1503), Silver Spring, MD 20993. For 

those unable to attend in person, the 

meeting will also be Web cast. The link 

for the Web cast is available at 

https://collaboration.fda.gov/ 

scienceboard/. Information regarding 

special accommodations due to a 

disability, visitor parking, and 

transportation may be accessed at: 

http://www.fda.gov/ 

AdvisoryCommittees/default.htm; under 

the heading ‘‘Resources for You,’’ click 

on ‘‘Public Meetings at the FDA White 

Oak Campus.’’ Please note that visitors 

to the White Oak Campus must enter 

through Building 1. 

CONTACT PERSON FOR MORE INFORMATION: 

Martha Monser, Office of the 

Commissioner, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, rm. 4286, Silver Spring, 

MD 20993, 301–796–4627, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area). 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: The Science Board will be 

provided with an overview of 

Georgetown University’s proposed 

programs under the Centers for 

Excellence in Regulatory Science and 

Innovation (CERSI) initiative. In 

addition, the Board will also hear about 

CERSI activities resulting from the 

Memorandum of Understanding 

between the National Center for 

Toxicological Research and the state of 

Arkansas. The Board will also be 

provided with an overview of ongoing 

genomic efforts at FDA as well as an 

update on Foods activities and an 

update regarding Scientific Computing 

efforts. 

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. 


wreier-aviles on DSK5TPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 70 / Wednesday, April 11, 2012 / Notices 21785 

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 April 25, 2012. Oral 

presentations from the public will be 

scheduled between approximately 1 

p.m. and 2 p.m. Those individuals 

interested in making 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 April 17, 

2012. 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 April 18, 2012. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Martha 

Monser at least 7 days in advance of the 

meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

http://www.fda.gov/ 

AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: April 5, 2012. 

David Dorsey, 

Acting Associate Commissioner for Policy and 

Planning. 

[FR Doc. 2012–8701 Filed 4–10–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0001] 

Medical Countermeasures Initiative 

Regulatory Science Symposium 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of meeting. 

The Food and Drug Administration 

(FDA) is announcing the following 

meeting: Medical Countermeasures 

Initiative Regulatory Science 

Symposium. The symposium is 

intended to provide a forum for the 

exchange of ideas for medical 

countermeasure development, highlight 

work on regulatory science as it applies 

to the development and advancement of 

medical countermeasures, facilitate 

innovative directions, and inform 

stakeholders on medical 

countermeasure-related scientific 

progress and accomplishments. 

Date and Time: This symposium will 

be held on Tuesday, June 5 and 

Wednesday, June 6, 2012, from 8 a.m. to 

5:30 p.m. Persons interested in 

attending the symposium in person or 

viewing via Web cast must register by 

Tuesday, May 29, 2012, at 5 p.m. EST. 

Location: The symposium will be 

held at the FDA White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31, 

rm. 1503, Silver Spring, MD 20993– 

0002. 

Contact: Rakesh Raghuwanshi, Office 

of Counterterrorism and Emerging 

Threats, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 32, 

rm. 4283, 301–796–4769, FAX: 301– 

847–8615, email: Rakesh.Raghuwanshi 

@fda.hhs.gov. 

Registration: If you wish to attend the 

symposium or view via Web cast, you 

must register at http://www.fda.gov/ 

medicalcountermeasures by Tuesday, 

May 29, 2012, at 5 p.m. EST. When 

registering, you must provide the 

following information: (1) Your name, 

(2) title, (3) company or organization (if 

applicable), (4) mailing address, (5) 

phone number, and (6) email address. 

There is no fee to register for the 

symposium and registration will be on 

a first-come, first-served basis. Early 

registration is recommended because 

seating is limited. If you need special 

accommodations due to a disability, 

please enter pertinent information in the 

‘‘Notes’’ section of the electronic 

registration form when you register. 

Dated: April 6, 2012. 

David Dorsey, 

Acting Associate Commissioner for Policy and 

Planning. 

[FR Doc. 2012–8695 Filed 4–10–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB Review; 

Comment Request: Prevalence, 

Incidence, Epidemiology and 

Molecular Variants of HIV in Blood 

Donors in Brazil 

Summary: Under the provisions of 

Section 3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the National 

Heart, Lung, and Blood Institute 

(NHLBI), the National Institutes of 

Health (NIH) has submitted to the Office 

of Management and Budget (OMB) a 

request for review and approval of the 

information collection listed below. 

This proposed information collection 

was previously published in the Federal 

Register on January 13, 2012, page 2072, 

and allowed 60 days for public 

comment. No public comments were 

received. The purpose of this notice is 

to allow an additional 30 days for public 

comment. The National Institutes of 

Health may not conduct or sponsor, and 

the respondent is not required to 

respond to, an information collection 

that has been extended, revised, or 

implemented on or after October 1, 

1995, unless it displays a currently valid 

OMB control number. 

Proposed Collection: Title: 

Prevalence, Incidence, Epidemiology 

and Molecular Variants of HIV in Blood 

Donors in Brazil. Type of Information 

Collection Request: Reinstatement 

(OMB No. 0925–0597). Need and Use of 

Information Collection: Establishing and 

monitoring viral prevalence and 

incidence rates, and identifying 

behavioral risk behaviors for HIV 

infection among donors are critical steps 

to assessing and reducing risk of HIV 

transmission through blood transfusion. 

Detecting donors with recently acquired 

HIV infection is particularly critical as 

it enables characterization of the viral 

subtypes currently transmitted within 

the screened population. In addition to 

characterizing genotypes of recently 

infected donors for purposes of blood 

safety, molecular surveillance of 

incident HIV infections in blood donors 

serves important public health roles by 

identifying new HIV infections for antiretroviral treatment, and enabling 

documentation of the rates of primary 


wreier-aviles on DSK5TPTVN1PROD with NOTICES