Federal Register / Vol. 75, No. 189 / Thursday, September 30, 2010 / Notices 60463 

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN

Form name Number of 

hospitals 

Total burden 

hours 

Average hourly wage rate* Total cost burden 

Focus groups at intervention sites .................................................................. 6 36 $57.38 $2,066 

Focus groups at control sites .......................................................................... 5 23 57.38 1,320 

ASP Questionnaire .......................................................................................... 11 180 64.73 11,651 

Total .......................................................................................................... 22 239 n/a 15,037 

* The hourly wage for the focus 

groups is based upon the mean of the 

average wages for physicians ($79.33), 

pharmacists ($50.13), and medical and 

health services managers ($42.67). The 

hourly wage for the surveys is based 

upon the average wages for physicians 

($79.33) and pharmacists ($50.13). 

These data come from the May 2008 

National Occupational Employment and 

Wage Estimates, United States,—U.S. 

Bureau of Labor Statistics Division of 

Occupational Employment Statistics, 

May 2008, National Occupational 

Employment and Wage Estimates, 

http://www.bls.gov/oes/2008/may/ 

oes_nat.htmb#11-0000. 

Estimated Annual Costs to the Federal 

Government 

Exhibit 3 shows the annualized and 

total cost to the federal government for 

this two year research project. Project 

Management includes activities related 

to coordination between BUSPH staff, 

contracted staff at MMC and GNYIIA, 

and monthly phone calls with the task 

order officer. Project development 

covers steps taken to revise the research 

plan and begin implementation. The 

total cost is estimated to be $999,995. 

EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST TO THE GOVERNMENT

Cost component Annualized 

cost Total cost 

Project Management ................................................................................................................................................ $28,315 $56,629 

Project Development ............................................................................................................................................... 84,944 169,400 

Data Collection and Analysis ................................................................................................................................... 169,888 339,776 

Technical Assistance and Consultation ................................................................................................................... 60,750 121,500 

Confirmatory lab testing ........................................................................................................................................... 20,000 40,000 

Travel ....................................................................................................................................................................... 7,500 15,000 

Project Supplies and materials ................................................................................................................................ 2,450 4,900 

Overhead ................................................................................................................................................................. 126,395 252,790 

Total .................................................................................................................................................................. 499,998 999,995 

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 healthcare research and 

healthcare 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: September 17, 2010. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 2010–24423 Filed 9–29–10; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0374] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Petition to Request 

an Exemption From 100 Percent 

Identity Testing of Dietary Ingredients: 

Current Good Manufacturing Practice 

in Manufacturing, Packaging, Labeling, 

or Holding Operations for Dietary 

Supplements 

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 November 

1, 2010. 

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 0910–0608. 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, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

3793. 

SUPPLEMENTARY INFORMATION: In 

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

has submitted the following proposed 

mstockstill on DSKH9S0YB1PROD with NOTICES6

60464 Federal Register / Vol. 75, No. 189 / Thursday, September 30, 2010 / Notices 

collection of information to OMB for 

review and clearance. 

Petition to Request an Exemption From 

100 Percent Identity Testing of Dietary 

Ingredients: Current Good 

Manufacturing Practice in 

Manufacturing, Packaging, Labeling, or 

Holding Operations for Dietary 

Supplements—(OMB Control Number 

0910–0608)—Extension 

On October 25, 1994, the Dietary 

Supplement Health and Education Act 

(DSHEA) (Public Law 103–417) was 

signed into law. DSHEA, among other 

things, amended the Federal Food, 

Drug, and Cosmetic Act (the FD&C Act) 

by adding section 402(g) of the FD&C 

Act (21 U.S.C. 342(g)). Section 402(g)(2) 

of the FD&C Act provides, in part, that 

the Secretary of Health and Human 

Services (the Secretary) may, by 

regulation, prescribe good 

manufacturing practices for dietary 

supplements. Section 402(g)(1) of the 

FD&C Act states that a dietary 

supplement is adulterated if ‘‘it has been 

prepared, packed, or held under 

conditions that do not meet current 

good manufacturing practice 

regulations.’’ Under section 701(a) of the 

FD&C Act (21 U.S.C. 371(a)), FDA may 

issue regulations necessary for the 

efficient enforcement of the FD&C Act. 

FDA published a final rule on June 

25, 2007 (72 FR 34752) (the final rule) 

that established, in part 111 (21 CFR 

part 111), the minimum Current Good 

Manufacturing Practice (CGMP) 

necessary for activities related to 

manufacturing, packaging, labeling, or 

holding dietary supplements to ensure 

the quality of the dietary supplement. 

On June 25, 2007 (72 FR 34959), FDA 

also published an Interim Final Rule 

(the IFR) establishing a procedure for a 

petition to request an exemption from 

100 percent identity testing of dietary 

ingredients. The IFR redesignated 

§ 111.75(a)(1) of the CGMP final rule as 

§ 111.75(a)(1)(i) and set forth a 

procedure for submission of a petition 

to FDA in a new § 111.75(a)(1)(ii), under 

which manufacturers may request an 

exemption from the requirements set 

forth in § 111.75(a)(1)(i) when the 

dietary ingredient is obtained from one 

or more suppliers identified in the 

petition. The regulation clarifies that 

FDA is willing to consider, on a case-bycase basis, a manufacturer’s conclusion, 

supported by appropriate data and 

information in the petition submission, 

that it has developed a system that it 

would implement as a sound, consistent 

means of establishing, with no material 

diminution of assurance compared to 

the assurance provided by 100 percent 

identity testing, the identity of the 

dietary ingredient before use. 

Section 111.75(a)(1) of the CGMP final 

rule reflects FDA’s determination that 

manufacturers that test or examine 100 

percent of the incoming dietary 

ingredients for identity can be assured 

of the identity of the ingredient. 

However, FDA recognizes that it may be 

possible for a manufacturer to 

demonstrate, through various methods 

and processes in use over time for its 

particular operation, that a system of 

less than 100 percent identity testing 

would result in no material diminution 

of assurance of the identity of the 

dietary ingredient as compared to the 

assurance provided by 100 percent 

identity testing. To provide an 

opportunity for a manufacturer to make 

such a showing and reduce the 

frequency of identity testing of 

components that are dietary ingredients 

from 100 percent to some lower 

frequency, FDA added to § 111.75(a)(1), 

an exemption from the requirement of 

100 percent identity testing when a 

manufacturer petitions the agency for 

such an exemption to 100 percent 

identity testing under § 10.30 and the 

agency grants such exemption. Such a 

procedure would be consistent with 

FDA’s stated goal, as described in the 

CGMP final rule, of providing flexibility 

in the CGMP requirements. Section 

111.75(a)(1)(ii) sets forth the 

information a manufacturer is required 

to submit in such a petition. The 

regulation also contains a requirement 

to ensure that the manufacturer keeps 

the FDA’s response to a petition 

submitted under § 111.75(a)(1)(ii) as a 

record under § 111.95. The collection of 

information in § 111.95 has been 

approved under OMB control number 

0910–0606. 

Description of Respondents: The 

respondents to this collection of 

information are firms in the dietary 

supplement industry, including dietary 

supplement manufacturers, packagers 

and re-packagers, holders, labelers and 

re-labelers, distributors, warehouses, 

exporters, importers, large businesses, 

and small businesses. 

In the Federal Register of July 20, 

2010 (75 FR 42095) FDA published a 60- 

day notice requesting public comment 

on the proposed collection of 

information. No comments were 

received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section Number of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

111.75(a)(1)(ii) 1 1 1 8 8 

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

In the last 3 years, FDA has not 

received any new petitions to request an 

exemption from 100 percent identity 

testing of dietary ingredients; therefore, 

the agency estimates that one or fewer 

petitions will be submitted annually. 

Although FDA has not received any new 

petitions to request an exemption from 

100 percent identity testing of dietary 

ingredients in the last 3 years, it 

believes that these information 

collection provisions should be 

extended to provide for the potential 

future need of a firm in the dietary 

supplement industry to petition for an 

exemption from 100 percent identity 

testing of dietary ingredients. Based on 

our experience with petition processes, 

we estimate that the assembly of 

information in support of the petition 

required by § 111.75(a)(1)(ii) will take 8 

hours. 

Dated: September 27, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–24642 Filed 9–29–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Notice of Meeting 

In accordance with section 10(d) of 

the Federal Advisory Committee Act (5 

U.S.C., Appendix 2), announcement is 

made of a Health Care Policy and 

Research Special Emphasis Panel (SEP) 

meeting. 

A Special Emphasis Panel is a group 

of experts in fields related to health care 

mstockstill on DSKH9S0YB1PROD with NOTICES6