Federal Register / Vol. 79, No. 220 / Friday, November 14, 2014 / Notices 68273 

beneficiaries and to educate 

beneficiaries about the process. If a prior 

authorization request is not affirmed, 

and the claim is still submitted by the 

provider/supplier, the claim will be 

denied in full, but beneficiaries will 

continue to have all applicable 

administrative appeal rights. 

Only one prior authorization request 

per beneficiary per designated time 

period can be provisionally affirmed. If 

the initial provider/supplier cannot 

complete the total number of prior 

authorized transports (for example, the 

initial ambulance company closes or no 

longer services that area), the initial 

request is cancelled. In this situation, a 

subsequent prior authorization request 

may be submitted for the same 

beneficiary and must include the 

required documentation in the 

submission. If multiple ambulance 

providers/suppliers are providing 

transports to the beneficiary during the 

same or overlapping time period, the 

prior authorization decision will only 

cover the provider/supplier indicated in 

the provisionally affirmed prior 

authorization request. Any provider/

supplier submitting claims for repetitive 

scheduled nonemergent ambulance 

transports for which no prior 

authorization request is recorded will be 

subject to 100 percent prepayment 

medical review of those claims. 

Additional information is available on 

the CMS Web site at http://go.cms.gov/ 

PAAmbulance. 

III. Collection of Information 

Requirements 

Section 1115A(d)(3) of the Act, as 

added by section 3021 of the Affordable 

Care Act, states that chapter 35 of title 

44, United States Code (the Paperwork 

Reduction Act of 1995), shall not apply 

to the testing and evaluation of models 

or expansion of such models under this 

section. Consequently, this document 

need not be reviewed by the Office of 

Management and Budget under the 

authority of the Paperwork Reduction 

Act of 1995 (44 U.S.C. 35). 

Authority: Section 1115A of the Social 

Security Act. 

Dated: October 8, 2014. 

Marilyn Tavenner, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2014–26987 Filed 11–13–14; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0279] 

Agency Information Collection 

Activities; Proposed Collection; 

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 an 

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 information collection in the 

regulations on the Prescription Drug 

Marketing Act of 1987; Administrative 

Procedures, Policies, and Requirements. 

DATES: Submit either electronic or 

written comments on the collection of 

information by January 13, 2015. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to: http://

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (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: 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: 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 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 

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68274 Federal Register / Vol. 79, No. 220 / Friday, November 14, 2014 / Notices 

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. 

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; (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 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 

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Federal Register / Vol. 79, No. 220 / Friday, November 14, 2014 / Notices 68275 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued 

21 CFR section Number of 

respondents 

Number of 

responses 

per 

respondent 

Total annual 

respondents 

Average burden 

per response Total hours 

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 2000 .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 record-keeping 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 ................................ 1200 

203.37(b) Loss or theft of drug samples ................. 50 40 2000 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: November 7, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–26917 Filed 11–13–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–N–0878] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Premarket 

Notification for a New Dietary 

Ingredient 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

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 procedure by which a manufacturer 

or distributor of a new dietary 

ingredient or of a dietary supplement 

containing a new dietary ingredient is to 

submit to FDA information upon which 

it has based its conclusion that a dietary 

supplement containing the new dietary 

ingredient will reasonably be expected 

to be safe. The notice also invites 

comments on two new forms FDA is 

developing to allow manufacturers and 

distributors to submit this information 

electronically via FDA’s Unified 

Registration and Listing System 

(FURLS). 

DATES: Submit either electronic or 

written comments on the collection of 

information by January 13, 2015. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http://

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

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