26356 Federal Register / Vol. 87, No. 86 / Wednesday, May 4, 2022 / Notices 

(‘‘TCA’’), and transferred its TCA assets 

to Long Grove. The Commission alleges 

in its Complaint that the Proposed 

Acquisition, if consummated, would 

violate Section 7 of the Clayton Act, as 

amended, 15 U.S.C. 18, and Section 5 of 

the Federal Trade Commission Act, as 

amended, 15 U.S.C. 45, by lessening 

future competition in the U.S. market 

for injectable TCA. The Consent 

Agreement will remedy the alleged 

violations by preserving the competition 

that otherwise would be eliminated by 

the Proposed Acquisition. 

Under the terms of the proposed 

Decision and Order (‘‘Order’’), 

Respondent Hikma shall not acquire any 

rights or interests in TCA products or 

assets, or any rights or interests in the 

therapeutical equivalent or biosimilar of 

TCA products without the prior 

approval of the Commission. The Order 

requires Respondents Long Grove and 

Water Street to operate and maintain in 

the normal course of business the TCA 

assets previously operated by 

Custopharm for a period lasting until 

four years after the Order date. 

The consent agreement has been 

placed on the public record for thirty 

days for receipt of comments from 

interested persons. Comments received 

during this period will become part of 

the public record. After thirty days, the 

Commission will again evaluate the 

Consent Agreement, along with the 

comments received, to make a final 

decision as to whether it should 

withdraw from the consent agreement, 

modify it, or make final the proposed 

Order. 

I. The Respondents 

Respondent Hikma is a multinational 

pharmaceutical company with 

headquarters in London, England, and 

U.S. headquarters in Berkeley Heights, 

New Jersey. Hikma manufactures both 

branded and generic pharmaceutical 

products, including generic injectables. 

Respondent Custopharm is 

incorporated in the State of Texas with 

its principal place of business located in 

Carlsbad, California. Water Street owns 

a majority of Custopharm. Custopharm 

develops generic pharmaceutical 

products but does not have any of its 

own manufacturing capabilities and 

manufacturers its products exclusively 

through contract manufacturers. Those 

products are then sold through 

Custopharm’s commrcial arm, Leucadia 

Pharmaceuticals. 

Respondent Water Street Healthcare 

Partners, LLC is a private equity firm 

headquartered in Chicago, Illinois. 

Water Street is the General Partner of 

Respondents Fund III and Fund IV. 

Respondent Fund III is a private equity 

fund managed by Water Street located 

in Chicago, Illinois. Fund III’s portfolio 

includes Custopharm. Respondent Fund 

IV is a private equity fund managed by 

Water Street located in Chicago, Illinois. 

Fund IV’s portfolio includes Long 

Grove. Respondent Long Grove is a 

pharmaceutical company launched in 

2019 and headquartered in Rosemont, 

Illinois. Long Grove is owned by Fund 

IV. 

II. The Relevant Market 

In human pharmaceutical markets, 

prices generally decrease as the number 

of generic competitors increases. Prices 

continue to decrease incrementally with 

the entry of the second, third, fourth, 

and further pharmaceutical competitors. 

Accordingly, a reduction in the number 

of suppliers within each relevant market 

has a direct and substantial effect on 

pricing. 

The Proposed Acquisition would 

reduce future competition in the market 

for injectable TCA. Injectable TCA is a 

corticosteroid used for severe skin 

conditions and inflammation. Only 

three competitors currently market 

injectable TCA: Bristol-Meyers Squibb, 

Amneal Biosciences, and Teva 

Pharmaceutical Industries. Hikma and 

Custopharm are two of a limited number 

of suppliers capable of entering the TCA 

market in the near future. 

III. Entry 

Entry into the market at issue 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. 

IV. Competitive Effects 

The effect of the Proposed 

Acquisition, if consummated, is likely 

to substantially lessen competition by 

eliminating future competition between 

Hikma and Custopharm in the market 

for injectable TCA. The evidence shows 

that the Proposed Acquisition, absent a 

remedy, would eliminate an additional 

independent entrant in the currently 

concentrated market for injectable TCA, 

which would have enabled customers to 

negotiate lower prices. Customers and 

competitors have observed—and the 

pricing data confirms—that the price of 

pharmaceutical products decreases with 

new entry even after several other 

suppliers have entered the market. 

Thus, absent a remedy, the Proposed 

Acquisition likely would cause U.S. 

consumers to pay significantly higher 

prices for injectable TCA in the future. 

V. The Proposed Order 

The proposed Order effectively 

remedies the competitive concerns 

raised by the Proposed Acquisition for 

the pharmaceutical product at issue. 

The proposed Order requires that Hikma 

not acquire any rights or interests in 

TCA products or assets, or rights or 

interests in the therapeutical equivalent 

or biosimilar of TCA products without 

the prior approval of the Commission. 

The proposed Order also requires Water 

Street and Long Grove to operate and 

maintain in the normal course of 

business the TCA assets for a period 

lasting until four years after the date the 

Order is issued. The proposed Order 

also allows the Commission to appoint 

an individual to serve as Monitor to 

observe and report on Respondents’ 

compliance with their obligations set 

forth in the Order. 

* * * * * 

The purpose of this analysis is to 

facilitate public comment on the 

Consent Agreement and proposed Order 

to aid the Commission in determining 

whether it should make the proposed 

Order final. This analysis is not an 

official interpretation of the proposed 

Order and does not modify its terms in 

any way. 

By direction of the Commission. 

April J. Tabor, 

Secretary. 

[FR Doc. 2022–09532 Filed 5–3–22; 8:45 am] 

BILLING CODE 6750–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Notice of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended, and the Determination of 

the Director, Strategic Business 

Initiatives Unit, Office of the Chief 

Operating Officer, CDC, pursuant to 

Public Law 92–463. The grant 

applications and the discussions could 

disclose confidential trade secrets or 

commercial property such as patentable 

material, and personal information 

concerning individuals associated with 

the grant applications, the disclosure of 

which would constitute a clearly 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 87, No. 86 / Wednesday, May 4, 2022 / Notices 26357 

unwarranted invasion of personal 

privacy. 

Name of Committee: Disease, 

Disability, and Injury Prevention and 

Control Special Emphasis Panel (SEP)— 

PAR 18–812, NIOSH Member Conflict 

Review. 

Date: June 16, 2022. 

Time: 1:00 p.m.–3:00 p.m., EDT. 

Place: Teleconference. 

Agenda: To review and evaluate grant 

applications. 

For Further Information Contact: 

Michael Goldcamp, Ph.D., Scientific 

Review Officer, Office of Extramural 

Programs, National Institute for 

Occupational Safety and Health, CDC, 

1095 Willowdale Road, Morgantown, 

West Virginia 26506, Telephone: (304) 

285–5951; Email: MGoldcamp@cdc.gov. 

The Director, Strategic Business 

Initiatives Unit, Office of the Chief 

Operating Officer, Centers for Disease 

Control and Prevention, has been 

delegated the authority to sign Federal 

Register notices pertaining to 

announcements of meetings and other 

committee management activities, for 

both the Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Kalwant Smagh, 

Director, Strategic Business Initiatives Unit, 

Office of the Chief Operating Officer, Centers 

for Disease Control and Prevention. 

[FR Doc. 2022–09580 Filed 5–3–22; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Solicitation of Nominations for 

Appointment to CDC’s Advisory 

Committee to the Director Data and 

Surveillance Workgroup 

ACTION: Notice. 

SUMMARY: The Centers for Disease 

Control and Prevention (CDC), within 

the Department of Health and Human 

Services (HHS), is seeking nominations 

for membership on the Advisory 

Committee to the Director (ACD) Data 

and Surveillance Workgroup (DSW). 

The DSW will consist of approximately 

15 members who are experts in fields 

associated with public health science 

and practice; policy development, 

analysis, and implementation; and 

surveillance and informatics. 

DATES: Nominations for membership on 

the DSW workgroup must be received 

no later than May 16, 2022. Late 

nominations will not be considered for 

membership. 

ADDRESSES: All nominations (cover 

letters and curriculum vitae) should be 

emailed to DSWACD@cdc.gov with the 

subject line: ‘‘Nomination for CDC ACD 

DSW Workgroup.’’ 

FOR FURTHER INFORMATION CONTACT: 

Rachel Holloway, MPH, Office of the 

Chief of Staff, Centers for Disease 

Control and Prevention, 1600 Clifton 

Road NE, Mailstop H21–10, Atlanta, 

Georgia 30329–4027; Telephone: (404) 

639–7000; Email: DSWACD@cdc.gov. 

SUPPLEMENTARY INFORMATION: 

Background: The purpose of the ACD, 

CDC is to advise the Secretary, HHS, 

and the Director, CDC, on policy and 

broad strategies that will enable CDC to 

fulfill its mission of protecting health 

through health promotion, prevention, 

and preparedness. The ACD, CDC 

consists of up to 15 non-federal 

members, including the Chair, 

knowledgeable in areas pertinent to the 

CDC mission, such as health policy, 

public health, global health, 

preparedness, preventive medicine, the 

faith-based and community-based 

sector, and allied fields. 

Purpose: The establishment and 

formation of the DSW is to provide 

input to the ACD, CDC on agency-wide 

activities related to the scope and 

implementation of CDC’s data 

modernization strategy across the 

agency, ultimately playing a key role in 

the agency’s work with public health, 

healthcare, and academic and private 

sector partners and with the promotion 

of equity. The DSW membership will 

consist of approximately 15 members. It 

will be co-chaired by two current ACD, 

CDC Special Government Employees. 

The DSW co-chairs will present their 

findings, observations, and work 

products at one or more ACD, CDC 

meetings for discussion, deliberation, 

and decisions (final recommendations 

to CDC). 

Nomination Criteria: DSW members 

will serve terms ranging from six 

months to one year and be required to 

attend DSW meetings approximately 1– 

2 times per month (virtually or in 

person), and contribute time between 

meetings for research, consultation, 

discussion, and writing assignments. 

Nominations are being sought for 

individuals who have the expertise and 

qualifications necessary to contribute to 

the accomplishments of the 

committee’s/workgroup’s objectives. 

Nominees will be selected based on 

expertise in the fields of public health 

science and practice; public health 

preparedness and response; public 

health policy development, analysis, 

and implementation; public health 

surveillance and informatics; data 

analysis, data science, and forecasting; 

health information technology; and 

healthcare delivery from jurisdictional 

government agencies, non-government 

organizations, academia, and the private 

sector. To ensure a diverse workgroup 

composition, nominees with front line 

and field experience at the local, state, 

tribal, and territorial levels are 

encouraged to apply. This includes 

nominees with experience working for, 

and with, community-based 

organizations and other non-profit 

organizations. Federal employees will 

not be considered for membership. 

Selection of members is based on 

candidates’ qualifications to contribute 

to the accomplishment of the DSW’s 

objectives. 

HHS policy stipulates that 

membership be balanced in terms of 

points of view represented and the 

workgroup’s function. 

Appointments shall be made without 

discrimination based on age, race, 

ethnicity, gender, sexual orientation, 

gender identity, HIV status, disability, 

and cultural, religious, or 

socioeconomic status. Nominees must 

be U.S. citizens and cannot be full-time 

employees of the U.S. Government. 

Current participation on federal 

workgroups or prior experience serving 

on a federal advisory committee does 

not disqualify a candidate; however, 

HHS policy is to avoid excessive 

individual service on advisory 

committees and multiple committee 

memberships. 

Interested candidates should submit 

the following items: 

D A one-half to one-page cover letter 

that includes your understanding of, 

and commitment to, the time and work 

necessary; one to two sentences on your 

background and experience; and one to 

two sentences on the skills/perspective 

you would bring to the DSW. 

D Current curriculum vitae which 

highlights the experience and work 

history being sought relevant to the 

criteria set forth above, including 

complete contact information 

(telephone numbers, mailing address, 

email address). 

Nominations may be submitted by the 

candidate him or herself, or by the 

person/organization recommending the 

candidate. 

The Director, Strategic Business 

Initiatives Unit, Office of the Chief 

Operating Officer, Centers for Disease 

Control and Prevention, has been 

delegated the authority to sign Federal 

Register notices pertaining to 

announcements of meetings and other 

committee management activities, for 


khammond on DSKJM1Z7X2PROD with NOTICES