78874 Federal Register / Vol. 79, No. 250 / Wednesday, December 31, 2014 / Notices 

revenue in 2013. Virbac Corp. is well 

suited to acquire the Sentinel products 

because of its current presence in the 

companion animal health business, and 

because it already has experience with 

canine heartworm products. Although 

Virbac currently sells canine heartworm 

products, their sales are relatively small 

and, because they do not contain an 

active ingredient to treat fleas, their 

competitive interaction with the 

Sentinel products is limited. 

The Order requires Eli Lilly to divest 

all of its respective rights and interests 

in the Sentinel products no later than 

ten days after the consummation of the 

Proposed Acquisition or on the date on 

which the Order becomes final, 

whichever is earlier. The divestiture 

includes all regulatory approvals, brand 

names, marketing materials, and 

confidential business information, 

including customer information, related 

to the Sentinel products, and other 

assets associated with producing, 

marketing and selling the Sentinel 

products. To ensure the divestiture is 

successful, the Order requires Eli Lilly 

and Novartis to secure all third-party 

consents and waivers required to permit 

Virbac to conduct business with the 

Sentinel products. The Order also 

requires Eli Lilly to divest supply chain 

assets related to the Sentinel products. 

These assets include certain rights and 

intellectual property for the active 

pharmaceutical ingredients in the 

Sentinel products. Additionally, Eli 

Lilly and Virbac must complete a 

technical transfer of manufacturing from 

Novartis to Virbac. The Order calls for 

an interim supply agreement of the 

Sentinel products for up to four years 

while Eli Lilly and Virbac complete the 

technical transfer. 

The Commission has agreed to 

appoint an Interim Monitor to ensure 

that Eli Lilly and Novartis comply with 

all of their obligations pursuant to the 

Consent Agreement and to keep the 

Commission informed about the status 

of the transfer of the rights and assets to 

Virbac. 

The Commission’s goal in evaluating 

possible purchasers of divested rights 

and assets is to maintain the 

competitive environment that existed 

prior to the Proposed Acquisition. If the 

Commission determines that Virbac is 

not an acceptable acquirer of the 

divested rights and assets, or that the 

manner of the divestitures is not 

acceptable, the parties must unwind the 

sale of rights and assets to Virbac and 

divest them to a Commission-approved 

acquirer within six months of the date 

the Order becomes final. In that 

circumstance, the Commission may 

appoint a trustee to divest the rights and 

assets if the parties fail to divest them 

as required. 

The purpose of this analysis is to 

facilitate public comment on the 

proposed Consent Agreement, and it is 

not intended to constitute an official 

interpretation of the proposed Order or 

to modify its terms in any way. 

By direction of the Commission. 

Janice Podoll Frankle, 

Acting Secretary. 

[FR Doc. 2014–30686 Filed 12–30–14; 8:45 am] 

BILLING CODE 6750–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–D–2254] 

The Drug Supply Chain Security Act 

Implementation: Product Tracing 

Requirements—Compliance Policy; 

Guidance for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance for industry 

entitled ‘‘DSCSA Implementation: 

Product Tracing Requirements— 

Compliance Policy.’’ This guidance 

announces FDA’s intention with regard 

to enforcement of certain product 

tracing requirements of the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act), as added by the Drug Supply 

Chain Security Act (DSCSA). FDA does 

not intend to enforce these requirements 

against manufacturers, wholesale 

distributors, and repackagers who do 

not, prior to May 1, 2015, provide or 

capture the transaction information, 

transaction history, and transaction 

statement required by the FD&C Act 

(product tracing information) for 

transaction of certain human, finished 

prescription drugs that are covered in 

the statute. 

DATES: Effective December 31, 2014. For 

information about enforcement dates, 

please see the SUPPLEMENTARY

INFORMATION section. 

ADDRESSES: All responses to this notice 

should be identified with Docket No. 

FDA–2014–D–2254 and directed to the 

office listed in the FOR FURTHER

INFORMATION CONTACT section of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Office of Compliance, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993–0002, 301–796–3100, 

drugtrackandtrace@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘DSCSA Implementation: Product 

Tracing Requirements—Compliance 

Policy.’’ This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

This guidance has been implemented 

without prior public comment because 

the Agency has determined that prior 

public participation is not feasible or 

appropriate. (§ 10.115(g)(2)). This 

guidance document provides 

information pertaining to statutory 

requirements that will take effect on 

January 1, 2015, regarding the 

provisions to provide and capture 

product tracing information under 

section 582(b)(1), (c)(1), and (e)(1) of the 

FD&C Act (21 U.S.C. 360eee–1(b)(1), 

(c)(1), and (e)(1)). It is important that 

FDA provide this information before 

that date. Although this guidance 

document is immediately in effect, it 

remains subject to comment in 

accordance with the Agency’s good 

guidance practices. (§ 10.115(g)(3)). 

On November 27, 2013, the DSCSA 

(Title II of Pub. L. 113–54) was signed 

into law. Section 202 of the DSCSA 

added sections 581 and 582 to the FD&C 

Act, which set forth new definitions and 

requirements for the tracing of products 

through the pharmaceutical distribution 

supply chain. Starting in 2015, trading 

partners (manufacturers, wholesale 

distributors, dispensers, and 

repackagers) will be required under 

section 582(b)(1), (c)(1), (d)(1), and (e)(1) 

of the FD&C Act, to exchange product 

tracing information when engaging in 

transactions involving certain 

prescription drugs. Manufacturers, 

wholesale distributors, and repackagers 

must meet these requirements by 

January 1, 2015; dispensers must meet 

these requirements by July 1, 2015. 

Although the product tracing 

requirements under section 582(b), (c), 

and (e) of the FD&C Act go into effect 

for manufacturers, wholesale 

distributors, and repackagers on January 

1, 2015, some trading partners have 

expressed concern that unforeseen 

complications with the exchange of the 

required information may result in 

disruptions in the pharmaceutical 

supply chain, and ultimately could 

impact patients’ access to needed 

prescription drugs. FDA recognizes that 

some manufacturers, wholesale 

distributors, and repackagers may need 

time beyond January 1, 2015, to work 

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Federal Register / Vol. 79, No. 250 / Wednesday, December 31, 2014 / Notices 78875 

with trading partners to ensure that all 

the proper product tracing information 

is provided and captured. To minimize 

possible disruptions in the distribution 

of prescription drugs in the United 

States, FDA does not intend to take 

action against trading partners who do 

not, prior to May 1, 2015, provide or 

capture the product tracing information 

required by section 582(b)(1), (c)(1), and 

(e)(1) of the FD&C Act. This compliance 

policy is limited to the requirements 

that trading partners provide and 

capture product tracing information; it 

does not extend to other requirements in 

section 582 of the FD&C Act, such as 

verification of suspect and illegitimate 

products (including quarantine, 

investigation, notification, and 

recordkeeping) or the requirement to 

engage only in transactions with 

authorized trading partners. 

II. Comments 

This guidance is for immediate 

implementation. FDA is issuing this 

guidance for immediate implementation 

in accordance with § 10.115(g)(2). 

Submit one set of either electronic or 

written comments on this guidance at 

any time. Submit electronic comments 

to http://www.regulations.gov. Submit 

written comments to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

You should identify all comments with 

Docket No. FDA–2014–D–2254. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the document at http://

www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/

Guidances/default.htm, http://

www.fda.gov/BiologicsBloodVaccines/

GuidanceComplianceRegulatory

Information/Guidances/default.htm, or 

http://www.regulations.gov. 

Dated: December 23, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–30608 Filed 12–30–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; 60-Day Comment 

Request Generic Clearance for the 

Collection of Qualitative Feedback on 

Agency Service Delivery (NIDA). 

SUMMARY: National Institute on Drug 

Abuse (NIDA), National Institutes of 

Health, as part of its continuing effort to 

reduce paperwork and respondent 

burden, invites the general public to 

take this opportunity to comment on the 

‘‘Generic Clearance for the Collection of 

Qualitative Feedback on Agency Service 

Delivery ’’ for approval under the 

Paperwork Reduction Act (PRA) (44 

U.S.C. 3501 et. seq.). This collection was 

developed as part of a Federal 

Government-wide effort to streamline 

the process for seeking feedback from 

the public on service delivery. This 

notice announces our intent to submit 

this collection to OMB for approval and 

solicits comments on specific aspects 

for the proposed information collection. 

To submit comments and for further 

information: To obtain a copy of the 

data collection plans and instruments, 

submit comments in writing, or request 

more information on the proposed 

project, contact: Genevieve deAlmeida, 

Ph.D., Health Research Evaluator, Office 

of Science Policy and Communications, 

National Institute on Drug Abuse, NIH, 

6001 Executive Boulevard, Bethesda, 

MD, Bethesda, MD 20892–9557, or call 

non-toll-free number (301) 594–6802, or 

Email your request, including your 

address to: dealmeig@nida.nih.gov 

Formal requests for additional plans and 

instruments must be requested in 

writing. 

Comment Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 60 days of the date of 

this publication. 

Proposed Collection: Generic 

Clearance for the Collection of 

Qualitative Feedback on Agency Service 

Delivery (NIDA), 0925–0655, Expiration 

Date 3/31/2015, EXTENSION, National 

Institute on Drug Abuse (NIDA). 

Need and Use of Information 

Collection: The information collected 

under this clearance will be qualitative 

customer and stakeholder feedback 

information—their perceptions, 

experiences and expectations of 

services, issues with service, to focus 

attention on areas where 

communication, training or changes in 

operations might improve delivery of 

products or services. The information 

will be useful and will allow for 

collaborative and actionable 

communications between the Agency 

and its customers and stakeholders, and 

will contribute directly to improving the 

programs and management of them. 

The information will not yield data 

that can be generalized to the overall 

population. The information may also 

be formative for the purpose of 

developing a concept for a new service 

program or dissemination program. The 

collections may still be eligible for 

submission for other generic 

mechanisms designed to yield 

quantitative results. 

The primary objectives are to obtain 

feedback on programs from customers 

and stakeholders, that would help make 

positive changes to the programs, or to 

assist in developing a new program or 

dissemination initiative, or to test 

medical tools and devices for usability, 

feasibility, and pilot testing of survey 

questionnaires for understandability. 

Data collection methods to be used in 

these studies include web-based and 

mailed surveys, focus groups, 

interviews with small groups, ad hoc 

collections at Conferences. The findings 

will provide valuable information to 

assist in improving programs that serve 

the public, and in developing good tools 

and devices to serve the public. OMB 

approval is requested for 3 years. 

NIDA will only submit a collection for 

approval under this generic clearance if 

it meets the following conditions: 

• The collections are voluntary; 

• The collections are low-burden for 

respondents (based on considerations of 

total burden hours, total number of 

respondents, or burden-hours per 

respondent) and are low-cost for both 

the respondents and the Federal 

Government; 

• The collections are noncontroversial and do not raise issues of 

concern to other Federal agencies; 

• Any collection is targeted to the 

solicitation of opinions from 

respondents who have experience with 

the program or may have experience 

with the program in the near future; 

• Personally identifiable information 

(PII) is collected only to the extent 

necessary and is not retained; 

• Information gathered will be used 

only internally for general service 

improvement and program management 

purposes and is not intended for release 

outside of the agency; 

• Information gathered will not be 

used for the purpose of substantially 

informing influential policy decisions; 

and 

• Information gathered will yield 

qualitative information; the collections 

will not be designed or expected to 

yield statistically reliable results or used 

as though the results are generalizable to 

the population of study. 

Feedback collected under this generic 

clearance provides useful information, 

but it does not yield data that can be 

generalized to the overall population. 

This type of generic clearance for 

qualitative information will not be used 

for quantitative information collections 

that are designed to yield reliably 

actionable results, such as monitoring 

trends over time or documenting 

program performance. Such data uses 

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