Federal Register / Vol. 80, No. 39 / Friday, February 27, 2015 / Notices 10697 

comments and suggestions submitted 

within 60 days of this publication. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2015–04138 Filed 2–26–15; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Comment Request 

Title: Annual Report on Households 

Assisted by the Low Income Home 

Energy Assistance (LIHEAP). 

OMB No. 0970–0060. 

Description: This report is an annual 

activity required by statute (42 U.S.C. 

8629) and Federal regulations (45 CFR 

96.92) for the Low Income Home Energy 

Assistance Program (LIHEAP). 

Submission of the completed report is 

one requirement for LIHEAP grantees 

applying for Federal LIHEAP block 

grant funds. 

States, the District of Columbia, and 

the Commonwealth of Puerto Rico are 

required to report statistics for the 

previous Federal fiscal year on: 

• Assisted and applicant households, 

by type of LIHEAP assistance; 

• Assisted and applicant households, 

by type of LIHEAP assistance and 

poverty level; 

• Assisted households receiving only 

utility payment assistance; 

• Assisted households, regardless of 

the type(s) of LIHEAAP assistance; 

• Assisted households, by type of 

LIHEAP assistance, having at least one 

vulnerable member broken out; by a 

person at least 60 years or younger, 

disabled person, or a child five years 

older of younger; 

• Assisted households, by type of 

LIHEAP assistance, with least one 

member age 2 years or under; 

• Assisted households, by type of 

LIHEAP assistance, with at least one 

member ages 3 years through 5 years; 

and 

• Assisted households, regardless of 

the type(s) of LIHEAP assistance, having 

at least one member 60 years or older, 

disabled, or five years old or younger. 

Insular areas (other than the 

Commonwealth of Puerto Rico) and 

Indian Tribal Grantees are required to 

submit data only on the number of 

households receiving heating, cooling, 

energy crisis, and/or weatherization 

benefits. 

The information is being collected for 

the Department’s annual LIHEAP Report 

to Congress. The data also provides 

information about the need for LIHEAP 

funds. Finally, the data are used in the 

calculation of LIHEAP performance 

measures under the Government 

Performance and Results Act of 1993. 

The data elements will allow the 

accuracy of measuring LIHEAP targeting 

performance and LIHEAP cost 

efficiency. 

Respondents: State Governments, 

Tribal Governments, Insular Areas, the 

District of Columbia, and the 

Commonwealth of Puerto Rico. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

Assisted Household Report-Long Form .......................................................... 52 1 25 1,300 

Assisted Household Report-Short Form .......................................................... 155 1 1 155 

Applicant Household Report ............................................................................ 52 1 13 676 

Estimated Total Annual Burden Hours ..................................................... ........................ ........................ ........................ 2,131 

In compliance with the requirements 

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

Paperwork Reduction Act of 1995, the 

Administration for Children and 

Families is soliciting public comment 

on the specific aspects of the 

information collection described above. 

Copies of the proposed collection of 

information can be obtained and 

comments may be forwarded by writing 

to the Administration for Children and 

Families, Office of Planning, Research 

and Evaluation, 370 L’Enfant 

Promenade SW., Washington, DC 20447, 

Attn: ACF Reports Clearance Officer. 

Email address: infocollection@

acf.hhs.gov. All requests should be 

identified by the title of the information 

collection. 

The Department specifically requests 

comments 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) 

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. 

Consideration will be given to 

comments and suggestions submitted 

within 60 days of this publication. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2015–04141 Filed 2–26–15; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0279] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Prescription Drug 

Marketing Act of 1987; Administrative 

Procedures, Policies, and 

Requirements 

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, 

2015. 

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10698 Federal Register / Vol. 80, No. 39 / Friday, February 27, 2015 / Notices 

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 0910–0435. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002, 

PRAStaff@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; Administrative Procedures, 

Policies, and Requirements—21 CFR 

Part 203—(OMB Control No. 0910– 

0435)—(Extension) 

FDA is requesting OMB approval 

under the PRA (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). 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 existing reporting and 

recordkeeping requirements: 

TABLE 1—REPORTING REQUIREMENTS

21 CFR section Requirement 

203.11 ............................................. Applications for re-importation to provide emergency medical care. 

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

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

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

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

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

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

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

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

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

TABLE 2—RECORDKEEPING REQUIREMENTS

21 CFR section Requirement 

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

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

203.30(a)(2) and 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. 

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

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

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

203.34 ............................................. Written policies and procedures describing administrative systems. 

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

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

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). 

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

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

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

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

203.50(a) ......................................... Drug origin statement. 

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

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

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Federal Register / Vol. 80, No. 39 / Friday, February 27, 2015 / Notices 10699 

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; (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; and 

(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 November 

14, 2014 (79 FR 68273), 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 BURDEN 1

21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

respondents 

Average burden 

per response Total hours 

203.11 Re-importation ................................................. 1 1 1 .50 (30 minutes) ..... 1 

203.30(a)(1) and (b) Drug sample requests ............... 61,961 12 743,532 .06 (4 minutes) ...... 44,612 

203.30(a)(3), (a)(4), (c) Drug sample receipts ............ 61,961 12 743,532 .06 (4 minutes) ....... 44,612 

203.31(a)(1) and (b) Drug sample requests ............... 232,355 135 31,367,925 .04 (2 minutes) ....... 1,254,717 

203.31(a)(3), (a)(4), (c) Drug sample receipts ............ 232,355 135 31,367,925 .03 (2 minutes) ....... 941,038 

203.37(a) Falsification of records ................................ 50 4 200 .25 (15 minutes) ..... 50 

203.37(b) Loss or theft of samples ............................. 50 40 2,000 .25 (15 minutes) ..... 500 

203.37(c) Convictions .................................................. 1 1 1 1 ............................. 1 

203.37(d) Contact person ............................................ 50 1 50 .08 (5 minutes) ...... 4 

203.39(g) Reconciliation report ................................... 1 1 1 1 ............................. 1 

Total ...................................................................... ........................ ........................ ........................ ................................ 2,285,536 

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

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR section Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average burden per 

recordkeeping Total hours 

203.23(a) and (b) Returned drugs .............................. 31,676 5 158,380 .25 (15 minutes) ..... 39,595 

203.23(c) Returned drugs documentation ................... 31,676 5 158,380 .08 (5 minutes) ...... 12,670 

203.30(a)(2) and 203.31(a)(2) Practitioner verification 2,208 100 220,800 .50 (30 minutes) ..... 110,400 

203.31(d)(1) and (d)(2) Inventory record and reconciliation report.2,208 1 2,208 40 ........................... 88,320 

203.31(d)(4) Investigation of discrepancies and 

losses.

442 1 442 24 ........................... 10,608 

203.31(e) Representatives lists ................................... 2,208 1 2,208 1 ............................. 2,208 

203.34 Administrative systems .................................... 90 1 90 40 ........................... 3,600 

203.37(a) Falsification of drug sample records ........... 50 4 200 6 ............................. 1,200 

203.37(b) Loss or theft of drug samples ..................... 50 40 2,000 6 ............................. 12,000 

203.39(d) Destroyed or returned drug samples .......... 65 1 65 1 ............................. 65 

203.39(e) Donated drug samples ................................ 3,221 1 3,221 .50 (30 minutes) ..... 1,611 

203.39(f) Distribution of donated drug samples .......... 3,221 1 3,221 8 ............................. 25,768 

203.39(g) Drug samples donated to charitable institutions.3,221 1 3,221 8 ............................. 25,768 

203.50(a) Drug origin statement ................................. 125 100 12,500 .17 (10 minutes) ..... 2,125 

203.50(b) Drug origin statement retention .................. 125 100 12,500 .50 (30 minutes) ..... 6,250 

203.50(d) Authorized distributors of record ................. 691 1 691 2 ............................. 1,382 

Total ...................................................................... ........................ ........................ ........................ ................................ 343,570 

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

Dated: February 23, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–04131 Filed 2–26–15; 8:45 am] 

BILLING CODE 4164–01–P 

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