1790 Federal Register / Vol. 75, No. 8 / Wednesday, January 13, 2010 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60Day–10–0217] 

Proposed Data Collections Submitted 

for Public Comment and 

Recommendations 

In compliance with the requirement 

of Section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995 for 

opportunity for public comment on 

proposed data collection projects, the 

Centers for Disease Control and 

Prevention (CDC) will publish periodic 

summaries of proposed projects. To 

request more information on the 

proposed projects or to obtain a copy of 

the data collection plans and 

instruments, call 404–639–5960 and 

send comments to Maryam I. Daneshvar, 

CDC Acting Reports Clearance Officer, 

1600 Clifton Road, MS–D74, Atlanta, 

GA 30333 or send an e-mail to 

omb@cdc.gov. 

Comments are invited on: (a) Whether 

the proposed collection of information 

is necessary for the proper performance 

of the functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. Written comments should 

be received within 60 days of this 

notice. 

Proposed Project 

Vital Statistics Training Application, 

(OMB No. 0920–0217 exp. 7/31/2010)— 

Extension—National Center for Health 

Statistics (NCHS), Centers for Disease 

Control and Prevention (CDC). 

Background and Brief Description 

In the United States, legal authority 

for the registration of vital events, i.e., 

births, deaths, marriages, divorces, fetal 

deaths, and induced terminations of 

pregnancy, resides individually with the 

States (as well as cities in the case of 

New York City and Washington, DC) 

and Puerto Rico, the Virgin Islands, 

Guam, American Samoa, and the 

Commonwealth of the Northern Mariana 

Islands. These governmental entities are 

the full legal proprietors of vital records 

and the information contained therein. 

As a result of this State authority, the 

collection of registration-based vital 

statistics at the national level, referred 

to as the U.S. National Vital Statistics 

System (NVSS), depends on a 

cooperative relationship between the 

States and the Federal government. This 

data collection, authorized by 42 U.S.C. 

242k, has been carried out by NCHS 

since it was created in 1960. 

NCHS assists in achieving the 

comparability needed for combining 

data from all States into national 

statistics, by conducting a training 

program for State and local vital 

statistics staff to assist in developing 

expertise in all aspects of vital 

registration and vital statistics. The 

training offered under this program 

includes courses for registration staff, 

statisticians, and coding specialists, all 

designed to bring about a high degree of 

uniformity and quality in the data 

provided by the States. This training 

program is authorized by 42 U.S.C. 

242b, section 304(a). In order to offer the 

types of training that would be most 

useful to vital registration staff 

members, NCHS requests information 

from State and local vital registration 

officials about their projected needs for 

training. NCHS also asks individual 

candidates for training to submit an 

application form containing name, 

address, occupation, work experience, 

education, and previous training. These 

data enable NCHS to determine those 

individuals whose needs can best be 

met through the available training 

resources. NCHS is requesting 3 years of 

OMB clearance for this project. 

There is no cost to respondents in 

providing these data. 

ESTIMATED ANNUALIZED BURDEN HOURS

Respondents Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

State, local, and Territory Registration Officials .............................................. 57 1 20/60 19 

Training applicants ........................................................................................... 100 1 15/60 25 

Total .......................................................................................................... 44 

Dated: January 7, 2010. 

Maryam I. Daneshvar, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. 2010–510 Filed 1–12–10; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0605] 

Draft Guidance for Institutional Review 

Boards, Clinical Investigators, and 

Sponsors: IRB Continuing Review 

After Clinical Investigation Approval; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance entitled, 

‘‘Guidance for IRBs, Clinical 

Investigators, and Sponsors: IRB 

Continuing Review After Clinical 

Investigation Approval.’’ The draft 

guidance announced in this notice is 

intended to assist institutional review 

boards (IRBs) in carrying out their 

continuing review responsibility by 

providing recommendations regarding 

the criteria, process, and frequency of 

continuing review to assure the 

protection of the rights and welfare of 

subjects in clinical investigations. The 

draft guidance should also help clinical 

investigators and sponsors better 

understand their responsibilities related 

to continuing review. 


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Federal Register / Vol. 75, No. 8 / Wednesday, January 13, 2010 / Notices 1791 

DATES: Although comments on any 

guidance can be submitted at any time 

(see 21 CFR 10.115(g)(5)), to ensure that 

the agency considers a comment on this 

draft guidance before it begins work on 

the final version of the guidance, 

written or electronic comments on the 

draft guidance should be submitted by 

March 15, 2010. Submit written 

comments on the draft guidance to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. Submit electronic comments 

to http://www.regulations.gov. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the draft guidance 

document. 

ADDRESSES: Submit written requests for 

single copies of this draft guidance to 

the Division of Drug Information, Center 

for Drug Evaluation and Research 

(CDER), Food and Drug Administration, 

10903 New Hampshire Ave., White Oak 

(WO) Bldg. 51, rm. 2201, Silver Spring, 

MD 20993–0002 (1–888–463–6332 or 

301–796–3400); or the Office of 

Communication, Outreach and 

Development (HFM–40), Center for 

Biologics Evaluation and Research 

(CBER), Food and Drug Administration, 

1401 Rockville Pike, suite 200N, 

Rockville, MD 20852–1448 (1–800–835– 

4709 or 301–827–1800); or the Division 

of Small Manufacturers, International, 

and Consumer Assistance, Center for 

Devices and Radiological Health 

(CDRH), Food and Drug Administration, 

10903 New Hampshire Ave. (WO Bldg. 

66, rm. 4622), Silver Spring, MD 20993 

(1–800–638–2041 or 301–796–7100). 

Send one self-addressed adhesive label 

to assist the office in processing your 

requests. 

FOR FURTHER INFORMATION CONTACT: Sara 

Goldkind, Office of Good Clinical 

Practice (HF–34), Food and Drug 

Administration, 5600 Fishers Lane, rm. 

16–85, Rockville, MD 20857, 301–827– 

3340. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance entitled, ‘‘Guidance for 

IRBs, Clinical Investigators, and 

Sponsors: IRB Continuing Review After 

Clinical Investigation Approval.’’ This 

guidance is intended to assist IRBs in 

carrying out their continuing review 

responsibility under 21 CFR 56.108(a) 

and 56.109(f) by providing 

recommendations regarding the criteria, 

process, and frequency of continuing 

review to assure the protection of the 

rights and welfare of subjects in clinical 

investigations. The draft guidance 

should also help clinical investigators 

and sponsors better understand their 

responsibilities related to continuing 

review. When finalized, this guidance 

will supersede the Information Sheet, 

‘‘Continuing Review After Study 

Approval’’ (September 1998, Office of 

Health Affairs, Food and Drug 

Administration). 

To enhance human subject protection 

and reduce regulatory burden, the 

Department of Health and Human 

Services, Office for Human Research 

Protections (OHRP) and FDA have been 

actively working to harmonize the 

agencies’ regulatory requirements and 

guidance for human subject research. 

This draft guidance document was 

developed as part of these efforts. 

FDA is issuing this as a draft guidance 

because it has been substantially revised 

in response to numerous questions 

about the continuing review process 

from the IRB and research communities. 

Changes include more detailed 

discussion about what should be 

submitted to assist the IRB in 

conducting continuing review, 

discussion of the circumstances in 

which expedited review procedures 

may be used for continuing review, and 

guidance about how continuing review 

dates should be determined. 

This draft guidance is part of the 

Information Sheet Guidance Initiative, 

announced in the Federal Register of 

February 3, 2006 (71 FR 5861), which 

describes FDA’s intention to update the 

process for developing, issuing, and 

making available guidances intended for 

IRBs, clinical investigators, and 

sponsors. Known as ‘‘Information 

Sheets,’’ these guidances have provided 

recommendations to IRBs, clinical 

investigators, and sponsors to help them 

fulfill their responsibilities to protect 

human subjects who participate in 

research regulated by the FDA. The 

Information Sheet Guidance Initiative is 

intended to ensure that the Information 

Sheets are updated, consistent with the 

FDA’s good guidance practices (GGPs). 

As part of the initiative, which will be 

ongoing, the agency plans to rescind 

Information Sheets that are obsolete, 

revise and reissue guidances that 

address current issues, and develop new 

guidance documents as needed. 

The draft guidance is being issued 

consistent with FDA’s GGPs regulation 

(21 CFR 10.115). The draft guidance, 

when finalized, will represent FDA’s 

current thinking on this topic. 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. The Paperwork Reduction Act of 

1995 

This draft guidance includes 

information collection provisions that 

are subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act (PRA) of 

1995 (44 U.S.C. 3501–3520) (PRA). The 

collections of information referenced in 

this guidance that are related to IRB 

recordkeeping requirements under 21 

CFR 56.115, which include the 

requirements for records of continuing 

review, have been approved under OMB 

Control No. 0910–0130; the collections 

of information in part 312 (21 CFR part 

312) have been approved under OMB 

control number 0910–0014; and the 

collections of information in part 812 

(21 CFR part 812) have been approved 

under OMB control number 0910–0078. 

In accordance with the PRA, prior to 

publication of any final guidance 

document, FDA intends to solicit public 

comment, and obtain OMB approval for 

any information collections 

recommended in this guidance that are 

new or that would represent material 

modifications to these previously 

approved collections of information 

found in FDA regulations. 

III. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this draft guidance. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified 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. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at http:// 

www.regulations.gov, or http:// 

www.fda.gov/ScienceResearch/ 

SpecialTopics/RunningClinicalTrials/ 

ProposedRegulationsand

DraftGuidances/default.htm 

Dated: January 7, 2010. 

David Dorsey, 

Acting Deputy Commissioner for Policy, 

Planning and Budget. 

[FR Doc. 2010–426 Filed 1–12–10; 8:45 am] 

BILLING CODE 4160–01–S 


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