Federal Register / Vol. 74, No. 37 / Thursday, February 26, 2009 / Notices 8799 

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS

Data collection mode Number of 

respondents 

Number of 

responses per 

respondent 

Hours per 

response 

Total burden 

hours 

Screening form ................................................................................ 124 1 3/60 6 

Self-administered questionnaire ...................................................... 84 1 6/60 8 

Focus group with parents of children <8 years of age (4 groups of 

8 participants) ............................................................................... 32 1 1.5 48 

Focus group with adults (4 groups of 8 participants) ...................... 32 1 1.5 48 

Semi-structured interviews with adolescents (13 to 20 years of 

age) .............................................................................................. 20 1 30/60 10 

Semi-structured interviews with primary care physicians ................ 20 1 20/60 7 

Semi-structured interviews with pharmacists .................................. 20 1 20/60 7 

Total .......................................................................................... 332 ............................ ............................ 134 

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN

Data collection mode Number of 

respondents 

Total burden 

hours 

Average hourly 

wage rate* Total cost burden 

Screening form ................................................................................ 124 6 $10.30 $62 

Self-administered questionnaire ...................................................... 84 8 10.30 82 

Focus groups with parents of children <8 years of age (4 groups 

of 8 participants) .......................................................................... 32 48 10.30 494 

Focus groups with adults (4 groups of 8 participants) .................... 32 48 10.30 494 

Semi-structured interviews with adolescents (13 to 20 years of 

age) .............................................................................................. 20 10 10.30 103 

Semi-structured interviews with primary care physicians ................ 20 7 61.10 428 

Semi-structured interviews with pharmacists .................................. 20 7 48.22 338 

Total .......................................................................................... 332 134 ............................ 2,001 

* Patient average hourly wage based on the average per capita income of $21,435 (computed into an hourly wage rate of $10.30) in Harris 

County, Texas where the study will take place. Provider hourly wage based on the following estimates from National Compensation Survey: Occupational wages in the United States 2006, U.S. Department of Labor, Bureau of Labor Statistics: Primary care physician = $61.10/hour; pharmacist = $48.22/hour. 

Estimates of Annualized Cost to the 

Government 

Exhibit 3 shows the estimated cost to 

the Federal Government for this six 

month project. 

The total cost is $164,440. This 

amount includes all direct and indirect 

costs of the design, data collection, 

analysis, and reporting phase of the 

study. 

EXHIBIT 3—ESTIMATED COST

Cost component Total cost 

Project Development ................ $13,250 

Data Collection Activities .......... 61,699 

Data Processing and Analysis 14,080 

Publication of Results ............... 750 

Project Management ................ 17,000 

Overhead .................................. 57,661 

Total ................................... 164,440 

Request for Comments 

In accordance with the above-cited 

Paperwork Reduction Act legislation, 

comments on AHRQ’s information 

collection are requested with regard to 

any of the following: (a) Whether the 

proposed collection of information is 

necessary for the proper performance of 

AHRQ health care research, quality 

improvement and information 

dissemination functions, including 

whether the information will have 

practical utility; (b) the accuracy of 

AHRQ’s estimate of burden (including 

hours and costs) of the proposed 

collection(s) 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 upon the 

respondents, including the use of 

automated collection techniques or 

other forms of information technology. 

Comments submitted in response to 

this notice will be summarized and 

included in the Agency’s subsequent 

request for OMB approval of the 

proposed information collection. All 

comments will become a matter of 

public record. 

Dated: February 17, 2009. 

Carolyn M. Clancy, 

Director. 

[FR Doc. E9–3959 Filed 2–25–09; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0631] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Medical Device 

Recall Authority 

AGENCY: Food and Drug Administration, 

HHS. 

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 March 30, 

2009. 

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, 

8800 Federal Register / Vol. 74, No. 37 / Thursday, February 26, 2009 / Notices 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–6974, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0432. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Denver Presley, Jr., Office of Information 

Management (HFA–710), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–3793. 

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. 

Medical Device Recall Authority—21 

CFR Part 810 (OMB Control Number 

0910–0432)—Extension 

This collection of information 

implements section 518(e) of the 

Federal Food, Drug, and Cosmetic Act 

(the act) (21 U.S.C. 360h) and part 810 

(21 CFR part 810) for the medical device 

recall authority provisions. Section 

518(e) of the act provides FDA with the 

authority to issue an order requiring an 

appropriate person, including 

manufacturers, importers, distributors, 

and retailers of a device, if FDA finds 

that there is reasonable probability that 

the device intended for human use 

would cause serious adverse health 

consequences or death to: (1) 

Immediately cease distribution of such 

device, (2) immediately notify health 

professionals and device-user facilities 

of the order, and (3) instruct such 

professionals and facilities to cease use 

of such device. 

Further, the provisions under section 

518 (e) of the act sets out a three- step 

procedure for issuance of a mandatory 

device recall order which are: (1) If 

there is a reasonable probability that a 

device intended for human use would 

cause serious, adverse health 

consequences or death, FDA may issue 

a cease distribution and notification 

order requiring the appropriate person 

to immediately: (a) Cease distribution of 

the device, (b) notify health 

professionals and device user facilities 

of the order, and (c) instruct those 

professionals and facilities to cease use 

of the device, (2) FDA will provide the 

person named in the cease distribution 

and notification order with the 

opportunity for an informal hearing on 

whether the order should be modified, 

vacated, or amended to require a 

mandatory recall of the device and, (3) 

after providing the opportunity for an 

informal hearing, FDA may issue a 

mandatory recall order if the agency 

determines that such an order is 

necessary. 

The information collected under the 

recall authority provisions will be used 

by FDA to: (1) Ensure that all devices 

entering the market are safe and 

effective, (2) accurately and 

immediately detect serious problems 

with medical devices, and (3) remove 

dangerous and defective devices from 

the market. 

In the Federal Register of December 

19, 2008 (73 FR 77719), FDA published 

a 60-day notice requesting public 

comment on the information collection 

provisions. No comments were received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

810.10(d) 2 1 2 8 16 

810.11(a) 1 1 1 8 8 

810.12(a-b) 1 1 1 8 8 

810.14 2 1 2 16 32 

810.15(a-c) 2 1 2 12 24 

810.15(d) 2 1 2 4 8 

810.15(e) 10 1 10 1 10 

810.16(a-b) 2 12 24 40 960 

810.17(a) 2 1 2 8 16 

Total 1,082 

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

TABLE 2.—ESTIMATED ANNUAL RECODKEEPING BURDEN1

21 CFR Section No. of 

Recordkeepers 

Annual Frequency 

per Recordkeeping 

Total Annual 

Records 

Hours per 

Record Total Hours 

810.15(b) 2 1 1 8 8 

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

Federal Register / Vol. 74, No. 37 / Thursday, February 26, 2009 / Notices 8801 

Explanation for Burden Estimates: 

The burden estimates for tables I and 

II of this document are based on FDA’s 

experience with voluntary recalls under 

part 810 of the regulations. FDA expects 

no more than two mandatory recalls per 

year, as most recalls are done 

voluntarily. Since the last time this 

collection of information was submitted 

to OMB for renewal/approval, there 

have been no mandatory recalls. 

Dated: February 18, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–4137 Filed 2–25–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of the following 

meetings. 

The meetings 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. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel Oral and 

Dental: Small Business. 

Date: March 5–6, 2009. 

Time: 9 a.m. to 12 a.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892. 

(Virtual Meeting). 

Contact Person: Tamizchelvi Thyagarajan, 

PhD, Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4016K, 

MSC 7814, Bethesda, MD 20892, 301–451– 

1327, tthyagar@csr.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, Pathogens 

and their Vectors. 

Date: March 12, 2009. 

Time: 10 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892. 

(Virtual Meeting). 

Contact Person: Richard G. Kostriken, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3192, 

MSC 7808, Bethesda, MD 20892, 301–402– 

4454, kostrikr@csr.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel Quick Trials 

on Imaging and Image-guided Intervention. 

Date: March 12, 2009. 

Time: 11 a.m. to 3 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892. 

(Virtual Meeting). 

Contact Person: John Firrell, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5213, 

MSC 7854, Bethesda, MD 20892, 301–435– 

2598, firrellj@csr.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, Infectious 

Agent Detection/Diagnosis, Food Safety, 

Sterilization/Disinfection and 

Bioremediation. 

Date: March 13, 2009. 

Time: 8 a.m. to 6 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Doubletree Guest Suites Santa 

Monica, 1707 Fourth Street, Santa Monica, 

CA 90401. 

Contact Person: Fouad A. El-Zaatari, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3206, 

MSC 7808, Bethesda, MD 20814–9692, (301) 

435–1149, elzaataf@csr.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, Specials of 

Genes, Genomes, and Genetics. 

Date: March 13, 2009. 

Time: 1 p.m. to 3 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892. 

(Telephone Conference Call). 

Contact Person: Michael A. Marino, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 2216, 

MSC 7890, Bethesda, MD 20892, (301) 435– 

0601, marinomi@csr.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, BTSS 

Member Conflict. 

Date: March 16, 2009. 

Time: 2 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892. 

(Virtual Meeting). 

Contact Person: Roberto J. Matus, MD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5108, 

MSC 7854, Bethesda, MD 20892, (301) 435– 

2204, matusr@csr.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, Member 

Conflict: Immune Mechanisms. 

Date: March 19, 2009. 

Time: 1 p.m. to 4 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892. 

(Telephone Conference Call). 

Contact Person: Jian, Wang, PhD, Scientific 

Review Officer, Center for Scientific Review, 

National Institutes of Health, 6701 Rockledge 

Drive, Room 4095D, MSC 7812, Bethesda, 

MD 20892, (301) 435–2778, 

wangjia@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, Health of 

the Population SBIR–2. 

Date: March 23, 2009. 

Time: 12 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892. 

(Virtual Meeting). 

Contact Person: Karin F. Helmers, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3148, 

MSC 7770, Bethesda, MD 20892, 301–435– 

1017, helmersk@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel Data 

Ontologies and Sharing Data and Tools. 

Date: March 24–25, 2009. 

Time: 8 a.m. to 4:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892. 

(Virtual Meeting). 

Contact Person: Alexander Gubin, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Rm 5144, MSC 

7812, Bethesda, MD 20892, 301–435–2902, 

gubina@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, Small 

Business: Digestive Sciences. 

Date: March 24–25, 2009. 

Time: 8 a.m. to 6 p.m.