1062 Federal Register / Vol. 75, No. 5 / Friday, January 8, 2010 / Notices 

data on the number of manufacturers 

that would be covered by the draft 

guidance, we estimate that 

approximately 70 manufacturers will 

develop an Emergency Plan as 

recommended by the draft guidance 

(i.e., 1 Plan per manufacturer to include 

all manufacturing facilities, sites, and 

drug products), and that each Plan will 

take approximately 500 hours to 

develop, maintain, and update. 

The draft guidance also encourages 

manufacturers to include a procedure in 

their Plan for notifying CDER when the 

Plan is activated and when returning to 

normal operations. The draft guidance 

recommends that these notifications 

occur within 1 day of a Plan’s activation 

and within 1 day of a Plan’s 

deactivation. The draft guidance 

specifies the information that should be 

included in these notifications, such as 

which drug products will be 

manufactured under altered procedures, 

which products will have 

manufacturing temporarily delayed, and 

any anticipated or potential drug 

shortages. We expect that approximately 

two notifications (for purposes of this 

analysis, we consider an activation and 

a deactivation notification to equal one 

notification) will be sent to CDER by 

approximately two manufacturers each 

year, and that each notification will take 

approximately 16 hours to prepare and 

submit. 

This draft guidance also refers to 

previously approved collections of 

information found in FDA regulations. 

Under the draft guidance, if a 

manufacturer obtains information after 

releasing a MNP under its Plan leading 

to suspicion that the product might be 

defective, CDER should be contacted 

immediately 

(drugshortages@fda.hhs.gov) in 

adherence to existing recall reporting 

regulations (21 CFR 7.40) (OMB control 

number 0910–0249) or defect reporting 

requirements for drug application 

products (21 CFR 314.81(b)(1)) and 

therapeutic biological products 

regulated by CDER (21 CFR 600.14) 

(OMB control numbers 0910–0001 and 

0910–0458, respectively). 

The following collections of 

information found in FDA current good 

manufacturing practice (CGMP) 

regulations in part 211 (21 CFR part 

211) are approved under OMB control 

number 0190–0139. The draft guidance 

encourages manufacturers to maintain 

records, in accordance with the CGMP 

requirements (see, e.g., § 211.180), that 

support decisions to carry out changes 

to approved procedures for 

manufacturing and release of products 

under the Plan. The draft guidance 

states: A Plan should be developed, 

written, reviewed, and approved within 

the site’s change control quality system 

in accordance with the requirements in 

§§ 211.100(a) and 211.160(a); execution 

of the Plan should be documented in 

accordance with the requirements 

described in § 211.100(b); and standard 

operating procedures should be 

reviewed and revised or supplementary 

procedures developed and approved to 

enable execution of the Plan. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Number of 

Respondents 

Number of Responses 

per Respondent Total Responses Hours per Response Total Hours 

Notify FDA of Plan activation and 

deactivation 2 1 2 16 32 

Total 32 

1There are no capital costs or operating and maintenance costs associated with this information collection. 

TABLE 2.—ESTIMATED RECORDKEEPING BURDEN1

Number of 

Recordkeepers 

Number of Records 

per Recordkeeping Total Records Hours per Record Total Hours 

Develop initial Plan 70 1 70 500 35,000 

Total 35,000 

1There are no capital costs or operating and maintenance costs associated with this information collection. 

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: January 4, 2010. 

David Dorsey, 

Acting Deputy Commissioner for Policy, 

Planning and Budget. 

[FR Doc. 2010–87 Filed 1–7–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Board of Scientific Counselors, 

National Center for Injury Prevention 

and Control, (BSC, NCIPC) 

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: 

Time and Date: 8:30 a.m.–5:30 p.m., 

January 22, 2010. 

Place: CDC, 4770 Buford Hwy., NE., 

Building 106, First Floor, Rooms 1B, Atlanta, 

Georgia 30341. 

Status: Open: 8:30 a.m.–11:30 a.m., January 

22, 2010. Closed: 11:30 a.m.–5:30 p.m., 

January 22, 2010. 

Purpose: The board makes 

recommendations regarding policies, 

strategies, objectives, and priorities, and 

reviews progress toward injury prevention 

goals and provides evidence in injury 

prevention-related research and programs. 

The board provides advice on the appropriate 

balance of intramural and extramural 

research, and provides advice on the 

structure, progress and performance of 

intramural programs. The Board of Scientific 

Counselors is also designed to provide 

guidance on extramural scientific program 

matters, including the: (1) Review of 

extramural research concepts for funding 


pwalker on DSK8KYBLC1PROD with NOTICES
Federal Register / Vol. 75, No. 5 / Friday, January 8, 2010 / Notices 1063 

opportunity announcements; (2) conduct of 

Secondary Peer Review of extramural 

research grants, cooperative agreements, and 

contracts applications received in response to 

the funding opportunity announcements as it 

relates to the Center’s programmatic balance 

and mission; (3) submission of secondary 

review recommendations to the Center 

Director of applications to be considered for 

funding support; (4) review of research 

portfolios; and (5) review of program 

proposals. The board shall provide guidance 

on the National Center of Injury Prevention 

and Control’s programs and research 

activities by conducting scientific peer 

review of intramural research and programs 

within the National Center for Injury 

Prevention and Control; by ensuring 

adherence to Office of Management and 

Budget requirements for intramural peer 

review; and by monitoring the overall 

direction, focus, and success of the National 

Center for Injury Prevention and Control. 

Matters to be Discussed: As this meeting of 

the Board of Scientific Counselors, the board 

will be discussing the upcoming portfolio 

topics, activities promoting the Injury 

Research Agenda, and other scientific 

matters. 

Agenda items are subject to change as 

priorities dictate. 

Contact Person for More Information: Dr. 

Gwendolyn Cattledge, PhD, MSEH, Deputy 

Associate Director for Science and the 

Designated Federal Officer for the Board of 

Scientific Counselors, NCIPC, CDC, 4770 

Buford Highway, NE., Mailstop F–63, 

Atlanta, Georgia 30341, Telephone (770) 

488–1430. 

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 CDC and the Agency for Toxic 

Substances and Disease Registry. 

Gary J. Johnson, 

Acting Director, Management Analysis and 

Services Office, Centers for Disease Control 

and Prevention. 

[FR Doc. 2010–22 Filed 1–7–10; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Clinical Laboratory Improvement 

Advisory Committee (CLIAC) 

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 committee 

meeting: 

Times and Dates: 

8:30 a.m.–5 p.m., February 9, 2010. 

8:30 a.m.–3 p.m., February 10, 2010. 

Place: CDC, 1600 Clifton Road, NE., 

Tom Harkin Global Communications 

Center, Building 19, Room 232, 

Auditorium B, Atlanta, Georgia 30333. 

Online Registration Required: In order 

to expedite the security clearance 

process at the CDC Roybal Campus 

located on Clifton Road, all CLIAC 

attendees are required to register for the 

meeting online at least 14 days in 

advance at http://wwwn.cdc.gov/cliac/ 

default.aspx by clicking the ‘‘Register for 

a Meeting’’ link and completing all 

forms according to the instructions 

given. Please complete all the required 

fields before submitting your 

registration and submit no later than 

January 26, 2010. 

Status: Open to the public, limited 

only by the space available. The meeting 

room accommodates approximately 100 

people. 

Purpose: This Committee is charged 

with providing scientific and technical 

advice and guidance to the Secretary of 

Health and Human Services, the 

Assistant Secretary for Health, and the 

Director, CDC, regarding the need for, 

and the nature of, revisions to the 

standards under which clinical 

laboratories are regulated; the impact on 

medical and laboratory practice of 

proposed revisions to the standards; and 

the modification of the standards to 

accommodate technological advances. 

Matters To Be Discussed: The agenda 

will include updates from the CDC, the 

Centers for Medicare & Medicaid 

Services, and the Food and Drug 

Administration; a report from the CLIAC 

Biochemical Genetic Testing Workgroup 

and discussion of the Workgroup’s 

proposals related to good laboratory 

practices for biochemical genetic 

testing; and presentations and 

discussions related to electronic health 

records and electronic transmission of 

laboratory information. 

Agenda items are subject to change as 

priorities dictate. 

Providing Oral or Written Comments: 

It is the policy of CLIAC to accept 

written public comments and provide a 

brief period for oral public comments 

whenever possible. 

Oral Comments: In general, each 

individual or group requesting to make 

an oral presentation will be limited to 

a total time of five minutes (unless 

otherwise indicated). Speakers must 

also submit their comments in writing 

for inclusion in the meeting’s Summary 

Report. To assure adequate time is 

scheduled for public comments, 

individuals or groups planning to make 

an oral presentation should, when 

possible, notify the contact person 

below at least one week prior to the 

meeting date. 

Written Comments: For individuals or 

groups unable to attend the meeting, 

CLIAC accepts written comments until 

the date of the meeting (unless 

otherwise stated). However, the 

comments should be received at least 

one week prior to the meeting date so 

that the comments may be made 

available to the Committee for their 

consideration and public distribution. 

Written comments, one hard copy with 

original signature, should be provided 

to the contact person below. Written 

comments will be included in the 

meeting’s Summary Report. 

Contact Person for Additional 

Information: Nancy Anderson, Chief, 

Laboratory Practice Standards Branch, 

Division of Laboratory Systems, 

National Center for Preparedness, 

Detection, and Control of Infectious 

Diseases, CDC, 1600 Clifton Road, NE., 

Mailstop F–11, Atlanta, Georgia 30333; 

telephone (404) 498–2741; fax (404) 

498–2219; or via e-mail at 

Nancy.Anderson@cdc.hhs.gov. 

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 CDC and the 

Agency for Toxic Substances and 

Disease Registry. 

Dated: December 30, 2009. 

Gary J. Johnson, 

Acting Director, Management Analysis and 

Services Office, Centers for Disease Control 

and Prevention. 

[FR Doc. 2010–100 Filed 1–7–10; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Dental & 

Craniofacial Research; Notice of 

Closed Meeting 

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 meeting. 

The meeting 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. 


pwalker on DSK8KYBLC1PROD with NOTICES