Federal Register / Vol. 74, No. 55 / Tuesday, March 24, 2009 / Notices 12365 

Microbial Food Safety Hazards for Fresh 

Fruits and Vegetables,’’ available at 

http://www.cfsan.fda.gov/~dms/ 

prodguid.html. The guidance addresses 

microbial food safety hazards and good 

agricultural and good management 

practices common to the growing, 

harvesting, washing, sorting, packing, 

and transporting of most fruits and 

vegetables sold to consumers in an 

unprocessed or minimally processed 

(raw) form. 

There is evidence that growers have 

not fully implemented the GAPs to 

reduce production risks, despite 

intensive GAPS training programs. FDA 

is planning to conduct a study to 

determine growers’ decision-making 

processes with regard to understanding 

and implementing GAPs on the farm, to 

more fully understand the barriers and 

constraints associated with GAPs 

implementation. 

The project will use ‘‘mental 

modeling,’’ a qualitative research 

method wherein the decision-making 

processes of a group of respondents 

(described below) concerning the 

implementation of GAPs on the farm are 

modeled and compared to a model 

based on expert knowledge and 

experience in the implementation of 

GAPs. The information will be collected 

via a telephone interview concerning 

the factors that influence the 

perceptions and motivations related to 

the implementation of GAPs. A 

comparison between expert and 

consumer models based on the collected 

information may identify 

‘‘consequential knowledge gaps’’ that 

can be redressed through information 

campaigns designed by FDA. 

Description of respondents: 

Respondents will be farmers or 

growers, GAPs trainers, and retail buyer 

and/or grower association 

representatives. 

In the Federal Register of July 1, 2008 

(73 FR 37464), FDA published a 60-day 

notice requesting public comment on 

the proposed information collection. 

FDA received one letter in response to 

the notice, containing one or more 

comments. One comment recommended 

that FDA increase the sample size and 

ensure that key subsets of the produce 

industry are surveyed. FDA responds 

that the proposed study is qualitative in 

nature. FDA does not intend the results 

of this study to be a quantitative 

estimate of the prevalence of the use of 

GAPs across the produce industry. The 

proposed sample size is sufficient to 

enable FDA to construct mental models 

of the barriers and constraints related to 

GAPs implementation. FDA agrees with 

the recommendation to ensure key 

subsets of the industry are included in 

the study. 

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 

Screener 80 1 80 0.02 2 

Pre-tests/ Cognitive Interviews 9 1 9 .75 6.75 

Farmers/ Growers 24 1 24 .75 18 

GAPs Trainers 24 1 24 .75 18 

Retail Buyers/ Growers Association Representatives 12 1 12 .75 9 

Total 53.75 

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

In the 60-day notice published on July 

1, 2008, FDA estimated the total burden 

hours to be 51.75. FDA has made 

changes to its burden estimate, reflected 

in table 1 of this document. FDA added 

a screener and listed the participants 

separately in the table. The new total 

burden hours are estimated to be 53.75 

and are described in the following 

paragraphs. 

Approximately 80 respondents will be 

screened. We estimate that it will take 

a respondent 1.2 minutes (0.02 hours) to 

complete the screening questions, for a 

total of 1.6 hours (rounded to 2). FDA 

will conduct 9 pretests; we estimate that 

it will take respondents 45 minutes 

(0.75 hours) to complete the pretest, for 

a total of 6.75 hours. Sixty respondents 

will complete the interview. We 

estimate that it will take respondents 45 

minutes (0.75 hours) to complete the 

entire interview, for a total of 45 hours. 

Thus, the total estimated burden is 

53.75 hours. FDA’s burden estimate is 

based on prior experience with mental 

models research that is similar to this 

proposed study. 

The study will involve approximately 

60 respondents, including 24 farmers or 

growers of fruits and vegetables, 24 

GAPs trainers, and 12 retail buyer or 

grower association representatives. FDA 

estimates that each respondent will take 

45 minutes (0.75 hours) to complete the 

interview for the study (60 respondents 

x 0.75 hours = 45 hours). 

Thus, the total annual burden for this 

one-time collection of information is 

53.75 hours (2 hours + 6.75 hours + 45 

hours = 53.75 hours). These estimates 

are based on FDA’s experience with 

consumer research. 

Dated: March 17, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–6393 Filed 3–23–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0664] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Prescription Drug 

Marketing Act of 1987 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

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12366 Federal Register / Vol. 74, No. 55 / Tuesday, March 24, 2009 / Notices 

opportunity for public comment on the 

proposed collection of certain 

information by the agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the reporting and recordkeeping 

requirements contained in the 

regulations implementing the 

Prescription Drug Marketing Act of 1987 

(PDMA) (Public Law 100–293). 

DATES: Submit written or electronic 

comments on the collection of 

information by May 26, 2009. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. Submit written 

comments on the collection of 

information to the Dockets Management 

Branch (HFA 305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Berbakos, Office of 

Information Management (HFA–710), 

Food and Drug Administration, 5600 

Fishers Lane, Rockville, MD 20857, 

301–796–3792. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Prescription Drug Marketing Act of 

1987; Administrative Procedures, 

Policies, and Requirements; 21 CFR 

Part 203 (OMB Control Number 0910– 

0435)—Extension 

FDA is requesting OMB approval 

under the Paperwork Reduction Act (44 

USC 3501–3520) for the reporting and 

recordkeeping requirements contained 

in the regulations implementing the 

PDMA. PDMA was intended to ensure 

that drug products purchased by 

consumers are safe and effective and to 

avoid an unacceptable risk that 

counterfeit, adulterated, misbranded, 

subpotent, or expired drugs are sold. 

PDMA was enacted by Congress 

because there were insufficient 

safeguards in the drug distribution 

system to prevent the introduction and 

retail sale of substandard, ineffective, or 

counterfeit drugs, and that a wholesale 

drug diversion submarket had 

developed that prevented effective 

control over the true sources of drugs. 

Congress found that large amounts of 

drugs had been reimported into the 

United States as U.S. goods returned 

causing a health and safety risk to U.S. 

consumers because the drugs may 

become subpotent or adulterated during 

foreign handling and shipping. Congress 

also found that a ready market for 

prescription drug reimports had been 

the catalyst for a continuing series of 

frauds against U.S. manufacturers and 

had provided the cover for the 

importation of foreign counterfeit drugs. 

Congress also determined that the 

system of providing drug samples to 

physicians through manufacturers’ 

representatives had resulted in the sale 

to consumers of misbranded, expired, 

and adulterated pharmaceuticals.The 

bulk resale of below-wholesale priced 

prescription drugs by health care 

entities for ultimate sale at retail also 

helped to fuel the diversion market and 

was an unfair form of competition to 

wholesalers and retailers who had to 

pay otherwise prevailing market prices. 

FDA is requesting OMB approval for 

the following reporting and 

recordkeeping requirements: 

REPORTING REQUIREMENTS 

21 CFR 203.11 Applications for reimportation to provide emergency medical care. 

21 CFR 203.30(a)(1) and (b) Drug sample requests (drug samples distributed by mail or common carrier). 

21 CFR 203.30(a)(3),(a)(4) and (c) Drug sample receipts (receipts for drug samples distributed by mail or common carrier). 

21 CFR 203.31(a)(1) and (b) Drug sample requests (drug samples distributed by means other than the mail or a common carrier). 

21 CFR 203.31(a)(3),(a)(4) and (c) Drug sample receipts (drug samples distributed by means other than the mail or a common carrier). 

21 CFR 203.37(a) Investigation of falsification of drug sample records. 

21 CFR 203.37(b) Investigation of a significant loss or known theft of drug samples. 

21 CFR 203.37(c) Notification that a representative has been convicted of certain offenses involving drug samples. 

21 CFR 203.37(d) Notification of the individual responsible for responding to a request for information about drug samples. 

21 CFR 203.39(g) Preparation by a charitable institution of a reconciliation report for donated drug samples. 

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Federal Register / Vol. 74, No. 55 / Tuesday, March 24, 2009 / Notices 12367 

RECORDKEEPING REQUIREMENTS 

21 CFR 203.23(a) and (b) Credit memo for returned drugs. 

21 CFR 203.23(c) Documentation of proper storage, handling, and shipping conditions for returned drugs. 

21 CFR 203.30(a)(2) 

and 21 CFR 203.31(a)(2) 

Verification that a practitioner requesting a drug sample is licensed or authorized by the appropriate 

State authority to prescribe the product. 

21 CFR 203.31(d)(1) and (d)(2) Contents of the inventory record and reconciliation report required for drug samples distributed by 

representatives. 

21 CFR 203.31(d)(4) Investigation of apparent discrepancies and significant losses revealed through the reconciliation report. 

21 CFR 203.31(e) Lists of manufacturers’ and distributors’ representatives. 

21 CFR 203.34 Written policies and procedures describing administrative systems. 

21 CFR 203.37(a) Report of investigation of falsification of drug sample records. 

21 CFR 203.37(b) Report of investigation of significant loss or known theft of drug samples. 

21 CFR 203.38(b) Records of drug sample distribution identifying lot or control numbers of samples distributed. (The information collection in 21 CFR 203.38(b) is already approved under OMB Control Number 0910– 

0139). 

21 CFR 203.39(d) Records of drug samples destroyed or returned by a charitable institution. 

21 CFR 203.39(e) Record of drug samples donated to a charitable institution. 

21 CFR 203.39(f) Records of donation and distribution or other disposition of donated drug samples. 

21 CFR 203.39(g) Inventory and reconciliation of drug samples donated to charitable institutions. 

21 CFR 203.50(a) Drug origin statement. 

21 CFR 203.50(b) Retention of drug origin statement for 3 years. 

21 CFR 203.50(d) List of authorized distributors of record. 

The reporting and recordkeeping 

requirements are intended to help 

achieve the following goals: 

(1) To ban the reimportation of 

prescription drugs produced in the U.S., 

except when reimported by the 

manufacturer or under FDA 

authorization for emergency medical 

care; 

(2) To ban the sale, purchase, or trade, 

or the offer to sell, purchase, or trade, 

of any prescription drug sample; 

(3) To limit the distribution of drug 

samples to practitioners licensed or 

authorized to prescribe such drugs or to 

pharmacies of hospitals or other health 

care entities at the request of a licensed 

or authorized practitioner; 

(4) To require licensed or authorized 

practitioners to request prescription 

drug samples in writing; 

(5) To mandate storage, handling, and 

recordkeeping requirements for 

prescription drug samples; 

(6) To prohibit, with certain 

exceptions, the sale, purchase, or trade 

of, or the offer to sell, purchase, or trade, 

prescription drugs that were purchased 

by hospitals or other health care 

entities, or which were donated or 

supplied at a reduced price to a 

charitable organization; 

(7) To require unauthorized wholesale 

distributors to provide, prior to the 

wholesale distribution of a prescription 

drug to another wholesale distributor or 

retail pharmacy, a statement identifying 

each prior sale, purchase, or trade of the 

drug. 

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 

203.11 1 1 1 .5 0.5 

203.30(a)(1) and (b) 61,961 12 743,532 .06 44,612 

203.30(a)(3), (a)(4) and (c) 61,961 12 743,532 .06 44,612 

203.31(a)(1) and (b) 232,355 135 31,367,925 .04 1,254,717 

203.31(a)(3), (a)(4) and (c) 232,355 135 31,367,925 .03 941,038 

203.37(a) 50 4 200 .25 50 

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12368 Federal Register / Vol. 74, No. 55 / Tuesday, March 24, 2009 / Notices 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued 

21 CFR Section No. of 

Respondents 

Annual 

Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

203.37(b) 50 40 2,000 .25 500 

203.37(c) 1 1 1 1 1 

203.37(d) 50 1 50 .08 4 

203.39(g) 1 1 1 1 1 

Total 2,285,535.50 

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

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of 

Recordkeepers 

Annual Frequency 

per 

Recordkeeping 

Total Annual 

Records 

Hours per 

Record Total Hours 

203.23(a) and (b) 31,676 5 158,380 .25 39,595 

203.23(c) 31,676 5 158,380 .08 12,670 

203.30(a)(2) and 203.31(a)(2) 2,208 100 220,800 .50 110,400 

203.31(d)(1) and (d)(2) 2,208 1 2,208 40 88,320 

203.31(d)(4) 442 1 442 24 10,608 

203.31(e) 2,208 1 2,208 1 2,208 

203.34 90 1 90 40 3,600 

203.37(a) 50 4 200 6 1,200 

203.37(b) 50 40 2,000 6 12,000 

203.39(d) 65 1 65 1 65 

203.39(e) 3,221 1 3,221 .50 1,610 

203.39(f) 3,221 1 3,221 8 25,768 

203.39(g) 3,221 1 3,221 8 25,768 

203.50(a) 0 0 0 0 0 

203.50(b) 0 0 0 0 0 

203.50(d) 0 0 0 0 0 

Total 324,092 

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

Dated: March 17, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–6394 Filed 3–23–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; Notice of Closed 

Meeting 

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 

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. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel. Vaccine Design PO1. 

Date: April 16, 2009. 

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