6720 Federal Register / Vol. 80, No. 25 / Friday, February 6, 2015 / Notices 

drug. Rather, generic suppliers compete 

only against each other. In generic 

pharmaceutical product markets, price 

generally decreases as the number of 

generic competitors increases. The 

United States is the relevant geographic 

market for generic drugs because the 

U.S. Food and Drug Administration 

(‘‘FDA’’) must approve them for sale 

within the United States. 

There are currently only three 

suppliers of each dosage strength of 

generic minocycline tablets in the 

United States: Ranbaxy, Dr. Reddy’s 

Laboratories Ltd., and Par 

Pharmaceutical Companies, Inc. Sun is 

one of only a limited number of firms 

likely to enter the generic minocycline 

tablets markets in the near future. Sun’s 

acquisition of Ranbaxy would therefore 

deprive consumers of the increased 

competition and likely price reductions 

that would have occurred as a result of 

Sun’s independent entry. 

II. Entry 

Entry into the markets for generic 

minocycline tablets would not be 

timely, likely, or sufficient in 

magnitude, character, and scope to deter 

or counteract the anticompetitive effects 

of the Proposed Acquisition. The 

combination of drug development times 

and regulatory requirements, including 

approval by the FDA, is costly and 

lengthy. 

III. Effects 

The Proposed Acquisition likely 

would cause significant anticompetitive 

harm to consumers by eliminating 

future competition that would otherwise 

have occurred when Sun’s generic 

minocycline tablets entered the markets. 

Market participants characterize generic 

minocycline tablets as commodities, 

and each market as one in which the 

number of generic suppliers has a direct 

impact on pricing. Customers and 

competitors have confirmed that the 

price of generic pharmaceutical 

products decreases with new entry even 

after several other suppliers have 

entered the market. Further, customers 

generally believe that having at least 

four suppliers in each generic 

pharmaceutical market produces more 

competitive prices than if fewer 

suppliers are available to them. 

The Proposed Acquisition would 

eliminate significant future competition 

between Sun and Ranbaxy. The 

evidence shows that anticompetitive 

effects are likely to result from the 

Proposed Acquisition due to the 

elimination of an additional 

independent competitor in the markets 

for generic minocycline tablets, which 

would have allowed customers to 

negotiate lower prices. Thus, absent a 

remedy, the Proposed Acquisition will 

likely cause U.S. consumers to pay 

significantly higher prices for generic 

minocycline tablets. 

IV. The Consent Agreement 

The proposed Consent Agreement 

effectively remedies the Proposed 

Acquisition’s anticompetitive effects in 

the relevant markets. Pursuant to the 

Consent Agreement and the Order, the 

parties are required to divest all of 

Ranbaxy’s rights and assets to generic 

minocycline tablets to Torrent. The 

parties must accomplish these 

divestitures and relinquish their rights 

no later than ten days after the Proposed 

Acquisition is consummated. 

The Commission’s goal in evaluating 

possible purchasers of divested assets is 

to maintain the competitive 

environment that existed prior to the 

Proposed Acquisition. If the 

Commission determines that Torrent is 

not an acceptable acquirer, or that the 

manner of the divestitures is not 

acceptable, the proposed Order requires 

the parties to unwind the sale of rights 

to Torrent and then divest the products 

to a Commission-approved acquirer 

within six months of the date the Order 

becomes final. The proposed Order 

further allows the Commission to 

appoint a trustee in the event the parties 

fail to divest the products as required. 

The proposed Consent Agreement and 

Order contain several provisions to help 

ensure that the divestitures are 

successful. The Order requires that 

Ranbaxy transfer to Torrent all 

confidential business information and 

requires that Sun and Ranbaxy take all 

actions that are necessary to maintain 

the full viability and marketing of the 

generic minocycline tablets until 

Torrent commences the distribution, 

marketing, and sale of the products. 

The proposed Order also requires the 

parties to divest Ranbaxy’s generic 

minocycline hydrochloride 50 mg, 75 

mg, and 100 mg capsules (‘‘minocycline 

capsules’’) to Torrent to ensure that 

Torrent achieves regulatory approval to 

qualify a new API supplier for its 

minocycline tablets as quickly as 

Ranbaxy would have. Torrent will be 

able to establish the current API 

supplier of the minocycline capsules as 

the API supplier for its minocycline 

tablets through a less time-intensive 

regulatory process if Torrent controls 

both products and uses the same API 

supplier for both. Moreover, the 

proposed Order requires Sun and 

Ranbaxy to manufacture and supply 

generic minocycline tablets and 

capsules to Torrent following the 

divestiture to allow Torrent to enter the 

markets while it validates its 

manufacturing process and seeks the 

necessary FDA approvals. 

The Commission will appoint Frank 

Civille to act as an interim monitor to 

assure that Sun and Ranbaxy 

expeditiously comply with all of their 

obligations and perform all of their 

responsibilities pursuant to the Consent 

Agreement. In order to ensure that the 

Commission remains informed about 

the status of the transfer of rights and 

assets, the Consent Agreement requires 

Sun and Ranbaxy to file reports with the 

interim monitor who will report in 

writing to the Commission concerning 

performance by the parties of their 

obligations under the Consent 

Agreement. 

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. 

Donald S. Clark, 

Secretary. 

[FR Doc. 2015–02461 Filed 2–5–15; 8:45 am] 

BILLING CODE 6750–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

[Document Identifier: HHS–OS–0990–New– 

30D] 

Agency Information Collection 

Activities; Submission to OMB for 

Review and Approval; Public Comment 

Request 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with section 

3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the Office of the 

Secretary (OS), Department of Health 

and Human Services, has submitted an 

Information Collection Request (ICR), 

described below, to the Office of 

Management and Budget (OMB) for 

review and approval. The ICR is for a 

new collection. Comments submitted 

during the first public review of this ICR 

will be provided to OMB. OMB will 

accept further comments from the 

public on this ICR during the review 

and approval period. 

DATES: Comments on the ICR must be 

received on or before March 9, 2015. 

ADDRESSES: Submit your comments to 

OIRA_submission@omb.eop.gov or via 

facsimile to (202) 395–5806. 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 25 / Friday, February 6, 2015 / Notices 6721 

FOR FURTHER INFORMATION CONTACT: 

Information Collection Clearance staff, 

Information.CollectionClearance@

hhs.gov or (202) 690–6162. 

SUPPLEMENTARY INFORMATION: When 

submitting comments or requesting 

information, please include the 

Information Collection Request Title 

and document identifier HHS–OS– 

0990–New–30D for reference. 

Information Collection Request Title: 

Evaluation of the National Training on 

Trauma-Informed Care (TIC). 

Abstract: The HHS OWH is requesting 

OMB approval to conduct a new, one 

time outcome evaluation of the National 

Training Initiative on Trauma-Informed 

Care (TIC) for Community-Based 

Providers From Diverse Service Systems 

training curriculum. Policymakers and 

providers in many service sectors 

recognize the central role of trauma in 

causing or complicating physical and 

behavioral health conditions and the 

critical need for trauma-informed care 

(TIC) systems. The proposed evaluation 

will capture both knowledge gained and 

implementation impact achieved as a 

result of the TIC training and TA. 

Analyses and findings will be used to 

further refine the TIC curriculum and 

training approach, and can help inform 

OWH and HHS in future policymaking 

efforts. Information collected will also 

help researchers and practitioners better 

understand the impact of adopting a 

trauma-informed approach on and the 

quality of care provided by communitybased providers. 

Likely respondents: 

Site Visits 

Site visits are designed to capture 

both the knowledge gained by training 

participants and the implementation 

impact achieved in their organizations 

as a result of the OWH TIC training and 

technical assistance. 

Online Survey 

The goal of the online survey is to 

assess the impact of the training on 

participants’ skills acquired in, 

knowledge about, and values and beliefs 

surrounding trauma-informed care. 

TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS

Form name Type of respondent Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

Online Survey ................................... Leadership and Line/Other Frontline 

Staff.

300 1 25/60 125 

Site Visits .......................................... Leadership and Line/Other Frontline 

Staff.

144 1 40/60 96 

Total ........................................... ........................................................... ........................ ........................ ........................ 221 

Darius Taylor, 

Information Collection Clearance Officer. 

[FR Doc. 2015–02313 Filed 2–5–15; 8:45 am] 

BILLING CODE 4150–33–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Solicitation of Written Comments on 

the Draft National Adult Immunization 

Plan 

AGENCY: National Vaccine Program 

Office, Office of the Assistant Secretary 

for Health, Office of the Secretary, 

Department of Health and Human 

Services. 

ACTION: Notice. 

SUMMARY: The National Vaccine 

Advisory Committee (NVAC) was 

established in 1987 to comply with Title 

XXI of the Public Health Service Act 

(Pub. L. 99–660) (§ 2105) (42 U.S. Code 

300aa–5 (PDF—78 KB)). Its purpose is to 

advise and make recommendations to 

the Director of the National Vaccine 

Program on matters related to program 

responsibilities. The Assistant Secretary 

for Health (ASH) has been designated by 

the Secretary of Health and Human 

Services (HHS) as the Director of the 

National Vaccine Program. The National 

Vaccine Program Office (NVPO) is 

located within the Office of the 

Assistant Secretary for Health (OASH), 

Office of the Secretary, U.S. Department 

of Health and Human Services (HHS). 

NVPO provides leadership and fosters 

collaboration among the various federal 

agencies involved in vaccine and 

immunization activities. The NVPO also 

supports the National Vaccine Advisory 

Committee (NVAC). The NVAC advises 

and makes recommendations to the 

ASH in his capacity as the Director of 

National Vaccine Program on matters 

related to vaccine program 

responsibilities. 

Adult vaccination rates remain low in 

the United States, and significant racial 

and ethnic disparities exist. In 2011, 

NVAC recommended the development 

of a strategic plan with the goal of 

improving adult immunization. 

Through an environmental scan of 

past reports issued by vaccine 

stakeholders, a survey, several focus 

groups, and in-depth interviews with 

subject matter experts, and in 

consultation with federal partners, 

NVPO has developed the draft National 

Adult Immunization Plan (NAIP). The 

NAIP details background on the 

immunization landscape and provides a 

strategic plan for federal and nonfederal 

stakeholders. 

NVPO is soliciting public comment 

on the draft NAIP from a variety of 

stakeholders, including the general 

public, for consideration as they 

develop their final report to the 

Secretary. It is anticipated that the draft 

NAIP, as revised with consideration 

given to public comment and 

stakeholder input, will be presented to 

the Secretary in the first quarter of 2015. 

DATES: Comments for consideration by 

NVPO should be received no later than 

5:00 p.m. EDT on March 9, 2015. 

ADDRESSES: (1) The draft NAIP is 

available on the web at http://

www.hhs.gov/nvpo/. 

(2) Electronic responses are preferred 

and may be addressed to: Rebecca.Fish@

hhs.gov. 

(3) Written responses should be 

addressed to: National Vaccine Program 

Office, U.S. Department of Health and 

Human Services, 200 Independence 

Avenue SW., Room 733G, Washington, 

DC 20201. Attn: HHS Adult 

Immunization c/o Rebecca Fish. 

FOR FURTHER INFORMATION CONTACT: 

Rebecca Fish, National Vaccine Program 

Office, Office of the Assistant Secretary 

for Health, Department of Health and 

Human Services; telephone (202) 260– 

9283; fax (202) 260–1165; email: 

Rebecca.Fish@hhs.gov. 

SUPPLEMENTARY INFORMATION: 


asabaliauskas on DSK5VPTVN1PROD with NOTICES