45216 Federal Register / Vol. 74, No. 168 / Tuesday, September 1, 2009 / Notices 

complete a brief quantitative interview 

after HIV referral or HIV testing is 

offered to them. HIV-seropositive 

injection-drug-using syringe customers 

who are identified during HIV testing 

will be immediately linked to social and 

medical services. Ten of the 12 ESAP 

Pharmacies will provide referrals to 

local HIV testing sites for their injectiondrug-using syringe customers. At these 

ten pharmacies, 40 adult pharmacy staff 

will be surveyed on pharmacy staff 

attitudes and behaviors regarding HIV 

testing and referral. 

The remaining two ESAP pharmacies 

will pilot test the feasibility of offering 

and performing HIV counseling and 

testing in the pharmacy for injectiondrug-using syringe customers. At these 

two pharmacies, 8 adult (age ≥18 yrs) 

pharmacy staff members will be 

surveyed on pharmacy staff attitudes 

and behaviors regarding HIV testing and 

referral. At the 12 pharmacies, 12 

pharmacy staff members (one from each 

pharmacy) will be surveyed monthly to 

track study progress and obstacles to 

completing the study. Twelve pharmacy 

staff members (one from each pharmacy) 

will complete a daily syringe sales and 

referral log. 

There is no cost to the injection drug 

using customers who provide 

information to this study other than 

their time. The total estimated annual 

burden hours are 496 hours. 

ESTIMATE OF ANNUALIZED BURDEN TABLE

Respondent Form name No. of 

respondents 

No. of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Pharmacist ...................................................... Pharmacy telephone screening and enrollment form.8 1 10/60 

Pharmacist and Pharmacy Technician ........... Pharmacy staff baseline survey ..................... 48 1 20/60 

Pharmacist and Pharmacy Technician ........... Pharmacy staff six monthly survey ................ 48 2 20/60 

Pharmacist and Pharmacy Technician ........... Pharmacy staff exit survey ............................. 48 1 20/60 

Pharmacist ...................................................... Pharmacy staff monthly survey ...................... 12 10 10/60 

Pharmacy Technician ..................................... Syringe sales and referral log ........................ 12 300 5/60 

Syringe-customer study participant ................ Pharmlink Participant Baseline Survey .......... 221 1 30/60 

Dated: August 26, 2009. 

Marilyn S. Radke, 

Reports Clearance Officer, Centers for Disease 

Control and Prevention. 

[FR Doc. E9–21037 Filed 8–31–09; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0131] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

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 

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 October 1, 

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, 

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 0910–0435. Also 

include the FDA 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, 

Elizabeth.Berbakos@fda.hhs.gov. 

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. 

Prescription Drug Marketing Act of 

1987; 21 CFR Part 203 (OMB Control 

Number 0910–0435)—Extension 

FDA is requesting OMB approval 

under the Paperwork Reduction Act (44 

U.S.C. 3501–3520) for the reporting and 

recordkeeping requirements contained 

in the regulations implementing the 

Prescription Drug Marketing Act of 1987 

(PDMA) (Public Law 100–293). 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: 

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Federal Register / Vol. 74, No. 168 / Tuesday, September 1, 2009 / Notices 45217 

TABLE 1.—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. 

TABLE 2.—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 

United States, 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; 

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45218 Federal Register / Vol. 74, No. 168 / Tuesday, September 1, 2009 / Notices 

(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. 

In the Federal Register of March 24, 

2009 (74 FR 12365), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. We received one comment. 

Comment Summary: The comment 

pertained to the recordkeeping 

requirements in § 203.50(a) and (b) (21 

CFR 203.50(a) and (b)). 

The comment concluded that FDA’s 

estimate of ‘‘0’’ recordkeeping hours for 

these regulations in table 2 of the March 

24, 2009, notice was in error. In 

summary, the comment contended: (1) 

Pedigrees must be passed by 

nonauthorized distributors of record 

prior to each wholesale distribution; (2) 

all wholesale distributors that provide 

or receive pedigrees after December 1, 

2006, must retain copies of the 

pedigrees for 3 years; and (3) those 

records must include names and 

addresses of all parties to the 

transaction and the date of the 

transactions. 

The comment offered no estimates for 

the recordkeeping provisions in 

§ 203.50(a) and (b). The comment 

explained that it is unable to suggest 

estimates for the burden hours because 

most of its members ‘‘have likely 

received a designation of ‘ADR’ status 

by most drug manufacturers for most of 

the prescription drug products that they 

purchase, and they provide pedigrees 

only on a limited basis.’’ Thus, the 

comment said, there are a large number 

of distributors that are not members of 

its organization but are subject to the 

pedigree requirements and, therefore, 

the burden hours that its members alone 

accrue would not be reflective of the 

entire population of distributors that are 

affected, and would likely be a minority 

of the total burden hours that all 

distributors experience. 

The comment recommended that FDA 

‘‘conduct a PRA review and estimate of 

the paperwork burden for healthcare 

distributors to comply with these 

regulations.’’ 

FDA Response: FDA appreciates the 

comment and, as requested, we plan to 

conduct research to obtain estimates for 

the burden hours that may be currently 

incurred by distributors to comply with 

the recordkeeping provisions in 

§ 203.50. We are requesting that 

interested persons submit to the docket 

(identified in brackets in the heading of 

this document) data on the burden 

hours currently incurred by distributors 

to comply with the recordkeeping 

provisions in § 203.50. In response to 

the comment, we are also adding to the 

Estimated Annual Recordkeeping 

Burden (table 4 of this document) 

recordkeeping estimates for § 203.50. 

We used these estimates in previous 

Federal Register notices based on 

information we received at that time, 

and no comments were received on 

these burden hours. If our research 

results in new data that differs from 

these estimates, we will amend the 

approval for OMB control number 

0910–0435 to include revised estimates 

for these provisions. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 3.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours2

203.11 1 1 1 .5 1 

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 

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 Reporting Burden Hours 2,285,536 

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

2Estimates are not exact due to rounding. 

TABLE 4.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of 

Respondents 

Annual Frequency 

per Recordkeeping 

Total Annual 

Responses 

Hours per 

Response Total Hours2

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

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

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Federal Register / Vol. 74, No. 168 / Tuesday, September 1, 2009 / Notices 45219 

TABLE 4.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1—Continued 

21 CFR Section No. of 

Respondents 

Annual Frequency 

per Recordkeeping 

Total Annual 

Responses 

Hours per 

Response Total Hours2

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) 125 100 12,500 .17 2,125 

203.50(b) 125 100 12,500 .50 6,250 

203.50(d) 691 1 691 2 .0 1,382 

Total Recordkeeping Burden Hours 332,769 

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

2Estimates are not exact due to rounding. 

Dated: August 25, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–21026 Filed 8–31–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0406] 

Agency Emergency Processing Under 

Office of Management and Budget 

Review; Tobacco Product 

Establishment Registration and 

Submission of Certain Health 

Information 

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 emergency processing under 

the Paperwork Reduction Act of 1995 

(the PRA). The proposed collection of 

information concerns the submission of 

tobacco product establishment 

registration and submission of certain 

health information, including ingredient 

listing and health related documents, as 

required by The Family Smoking 

Prevention and Tobacco Control Act 

(FSPTCA). 

DATES: Fax written comments on the 

collection of information by September 

16, 2009. FDA is requesting approval of 

this emergency processing by September 

16, 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, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–6974. All comments should be 

identified with the title, ‘‘Tobacco 

Product Establishment Registration and 

Submission of Certain Health 

Information.’’ Also include the docket 

number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Jonna Capezzuto, Office of Information 

Management (HFA–250), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–3794, email: 

Jonnalynn.Capezzuto@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: FDA has 

requested emergency processing of this 

proposed collection of information 

under section 3507(j) of the PRA (44 

U.S.C. 3507(j)) and 5 CFR 1320.13. On 

June 22, 2009, the President signed 

FSPTCA into law (Public Law 111–31). 

Section 101 of FSPTCA amends the 

Federal Food, Drug, and Cosmetic Act 

(the act) by adding, among other things, 

new sections 904 (21 U.S.C. 394) and 

905 (21 U.S.C. 395). Section 905 

requires the annual registration of any 

‘‘establishment in any State engaged in 

the manufacture, preparation, 

compounding, or processing of a 

tobacco product or tobacco products.’’ 

Section 905 also requires this 

registration be completed by December 

31 of each year. To allow adequate time 

for establishment owners and operators 

to complete the registration process, and 

to match similar provisions applicable 

to other FDA regulated products, FDA 

plans to begin accepting establishment 

registrations on October 1, 2009. 

Section 904(a)(1) of the act requires 

each tobacco product manufacturer or 

importer, or agent thereof to submit a 

listing of all ingredients, including 

tobacco, substances, compounds, and 

additives that are, as of such date, added 

by the manufacturer to the tobacco, 

paper, filter, or other part of each 

tobacco product by brand and by 

quantity in each brand and subbrand. 

Section 904(a)(4) requires each tobacco 

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