ANI/Novitium; Analysis of Agreement Containing Consent Orders To Aid Public Comment, 68668-68671 [2021-26294]
Download as PDF
<![CDATA[
68668
Federal Register / Vol. 86, No. 230 / Friday, December 3, 2021 / Notices
performance of the Board’s functions,
including whether the information has
practical utility;
b. The accuracy of the Board’s
estimate of the burden of the proposed
information collection, including the
validity of the methodology and
assumptions used;
c. Ways to enhance the quality,
utility, and clarity of the information to
be collected;
d. Ways to minimize the burden of
information collection on respondents,
including through the use of automated
collection techniques or other forms of
information technology; and
e. Estimates of capital or startup costs
and costs of operation, maintenance,
and purchase of services to provide
information.
At the end of the comment period, the
comments and recommendations
received will be analyzed to determine
the extent to which the Board should
modify the proposal.
jspears on DSK121TN23PROD with NOTICES1
Proposal Under OMB Delegated
Authority To Extend for Three Years,
Without Revision, the Following
Information Collection
Report title: Recordkeeping and
Disclosure Requirements Associated
with Regulation II.
Agency form number: FR II.
OMB control number: 7100–0349.
Frequency: On occasion.
Respondents: State member banks,
national banks, insured nonmember
banks, savings associations, and
federally-chartered credit unions.
Estimated number of respondents:
Implement policies and procedures, 1;
Review and update policies and
procedures, 527; General recordkeeping,
527; Annual notification and change in
status, 527.
Estimated average hours per response:
Implement policies and procedures,
160; Review and update policies and
procedures, 40; General recordkeeping,
1; Annual notification and change in
status, 1.
Estimated annual burden hours:
Implement policies and procedures,
160; Review and update policies and
procedures, 21,080; General
recordkeeping, 527; Annual notification
and change in status, 527.
General description of report:
Regulation II—Debit Card Interchange
Fees and Routing (12 CFR part 235)
implements, among other things,
standards for assessing whether
interchange transaction fees for
electronic debit transactions are
reasonable and proportional to the cost
incurred by the issuer with respect to
the transaction, as required by section
VerDate Sep<11>2014
18:06 Dec 02, 2021
Jkt 256001
920(a) of the Electronic Fund Transfer
Act (EFTA) (15 U.S.C. 1693o–2(a)).
Regulation II limits the interchange
transaction fee that covered issuers
(issuers that, together with affiliates,
have assets of $10 billion or more) can
charge for electronic debit transactions.
Under the rule, a covered debit card
issuer is allowed to receive or charge an
interchange transaction fee in the
amount of 21 cents plus 5 basis points
multiplied by the value of the
transaction. In addition, a covered
issuer may receive or charge an amount
of no more than 1 cent per transaction
(the ‘‘fraud-prevention adjustment’’) for
the costs associated with preventing
fraudulent electronic debit transactions
(fraud-prevention adjustment) if the
issuer complies with the standards and
requirements set forth in the rule. In
addition to these interchange fee
provisions, Regulation II prohibits any
issuer (i.e., not just covered issuers) or
payment card network from directly or
indirectly restricting the number of
payment card networks on which an
electronic debit transaction may be
processed to less than two unaffiliated
networks, and from directly or
indirectly inhibiting the ability of a
merchant to direct the routing of
electronic debit transactions for
processing over any payment card
network that may process such
transactions. Finally, Regulation II
prohibits any issuer from receiving net
compensation from a payment card
network with respect to electronic debit
transactions or debit card-related
activities within a calendar year.
Legal authorization and
confidentiality: The Recordkeeping and
Disclosure Requirements Associated
with Regulation II are authorized by
section 920(a)(3) of the EFTA.1 The
fraud-prevention and disclosure
requirements are additionally
authorized by section 920(a)(5) of the
EFTA.2 Regulation II’s general
recordkeeping requirement for issuers is
mandatory. Regulation II’s fraudprevention recordkeeping requirements
and disclosure requirements are
required to obtain a benefit.
The Recordkeeping and Disclosure
Requirements Associated with
Regulation II are generally not
submitted to the Board or to any of the
federal financial regulatory agencies. In
1 15 U.S.C. 1693o–2(a)(3) (authorizing the Board
to prescribe regulations regarding interchange
transaction fees and require issuers or payment card
networks to provide to the Board such information
as deemed necessary).
2 15 U.S.C. 1693o–2(a)(5) (permitting the Board
to allow for the fraud-prevention adjustment and
condition it upon compliance with fraud-related
standards promulgated by the Board).
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
the event that the Board obtains such
information, it may be kept confidential
under exemption 4 of the Freedom of
Information Act (FOIA) to the extent
that it contains commercial or financial
information both customarily and
actually treated as private.3 If such
information is obtained through the
examination or enforcement process, it
may be kept confidential under
exemption 8 of the FOIA.4
Board of Governors of the Federal Reserve
System, November 29, 2021.
Michele Taylor Fennell,
Deputy Associate Secretary of the Board.
[FR Doc. 2021–26319 Filed 12–2–21; 8:45 am]
BILLING CODE 6210–01–P
FEDERAL TRADE COMMISSION
[File No. 211 0101/Docket No. C–4754]
ANI/Novitium; Analysis of Agreement
Containing Consent Orders To Aid
Public Comment
Federal Trade Commission.
Proposed consent agreement;
request for comment.
AGENCY:
ACTION:
The consent agreement in this
matter settles alleged violations of
Federal law prohibiting unfair methods
of competition. The attached Analysis of
Proposed Consent Orders to Aid Public
Comment describes both the allegations
in the complaint and the terms of the
consent orders—embodied in the
consent agreement—that would settle
these allegations.
DATES: Comments must be received on
or before January 3, 2022.
ADDRESSES: Interested parties may file
comments online or on paper, by
following the instructions in the
Request for Comment part of the
SUPPLEMENTARY INFORMATION section
below. Please write: ‘‘ANI/Novitium;
File No. 211 0101’’ on your comment,
and file your comment online at https://
www.regulations.gov by following the
instructions on the web-based form. If
you prefer to file your comment on
paper, please mail your comment to the
following address: Federal Trade
Commission, Office of the Secretary,
600 Pennsylvania Avenue NW, Suite
CC–5610 (Annex D), Washington, DC
20580; or deliver your comment to the
following address: Federal Trade
Commission, Office of the Secretary,
Constitution Center, 400 7th Street SW,
5th Floor, Suite 5610 (Annex D),
Washington, DC 20024.
SUMMARY:
3
4
5 U.S.C. 552(b)(4).
5 U.S.C. 552(b)(8).
E:\FR\FM\03DEN1.SGM
03DEN1
Federal Register / Vol. 86, No. 230 / Friday, December 3, 2021 / Notices
Kari
Wallace (202–326–3085), Bureau of
Competition, Federal Trade
Commission, 400 7th Street SW,
Washington, DC 20024.
SUPPLEMENTARY INFORMATION: Pursuant
to Section 6(f) of the Federal Trade
Commission Act, 15 U.S.C. 46(f), and
FTC Rule 2.34, 16 CFR 2.34, notice is
hereby given that the above-captioned
consent agreement containing a consent
order to cease and desist, having been
filed with and accepted, subject to final
approval, by the Commission, has been
placed on the public record for a period
of thirty (30) days. The following
Analysis of Agreement Containing
Consent Orders to Aid Public Comment
describes the terms of the consent
agreement and the allegations in the
complaint. An electronic copy of the
full text of the consent agreement
package can be obtained from the FTC
website at this web address: https://
www.ftc.gov/news-events/commissionactions.
You can file a comment online or on
paper. For the Commission to consider
your comment, we must receive it on or
before January 3, 2022. Write ‘‘ANI/
Novitium; File No. 211 0101’’ on your
comment. Your comment—including
your name and your state—will be
placed on the public record of this
proceeding, including, to the extent
practicable, on the https://
www.regulations.gov website.
Due to protective actions in response
to the COVID–19 pandemic and the
agency’s heightened security screening,
postal mail addressed to the
Commission will be delayed. We
strongly encourage you to submit your
comments online through the https://
www.regulations.gov website.
If you prefer to file your comment on
paper, write ‘‘ANI/Novitium; File No.
211 0101’’ on your comment and on the
envelope, and mail your comment to the
following address: Federal Trade
Commission, Office of the Secretary,
600 Pennsylvania Avenue NW, Suite
CC–5610 (Annex D), Washington, DC
20580; or deliver your comment to the
following address: Federal Trade
Commission, Office of the Secretary,
Constitution Center, 400 7th Street SW,
5th Floor, Suite 5610 (Annex D),
Washington, DC 20024. If possible,
submit your paper comment to the
Commission by courier or overnight
service.
Because your comment will be placed
on the publicly accessible website at
https://www.regulations.gov, you are
solely responsible for making sure your
comment does not include any sensitive
or confidential information. In
jspears on DSK121TN23PROD with NOTICES1
FOR FURTHER INFORMATION CONTACT:
VerDate Sep<11>2014
18:06 Dec 02, 2021
Jkt 256001
particular, your comment should not
include sensitive personal information,
such as your or anyone else’s Social
Security number; date of birth; driver’s
license number or other state
identification number, or foreign
country equivalent; passport number;
financial account number; or credit or
debit card number. You are also solely
responsible for making sure your
comment does not include sensitive
health information, such as medical
records or other individually
identifiable health information. In
addition, your comment should not
include any ‘‘trade secret or any
commercial or financial information
which . . . is privileged or
confidential’’—as provided by Section
6(f) of the FTC Act, 15 U.S.C. 46(f), and
FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2)—
including in particular competitively
sensitive information such as costs,
sales statistics, inventories, formulas,
patterns, devices, manufacturing
processes, or customer names.
Comments containing material for
which confidential treatment is
requested must be filed in paper form,
must be clearly labeled ‘‘Confidential,’’
and must comply with FTC Rule 4.9(c).
In particular, the written request for
confidential treatment that accompanies
the comment must include the factual
and legal basis for the request, and must
identify the specific portions of the
comment to be withheld from the public
record. See FTC Rule 4.9(c). Your
comment will be kept confidential only
if the General Counsel grants your
request in accordance with the law and
the public interest. Once your comment
has been posted on https://
www.regulations.gov—as legally
required by FTC Rule 4.9(b)—we cannot
redact or remove your comment from
that website, unless you submit a
confidentiality request that meets the
requirements for such treatment under
FTC Rule 4.9(c), and the General
Counsel grants that request.
Visit the FTC website at https://
www.ftc.gov to read this Notice and the
news release describing this matter. The
FTC Act and other laws the Commission
administers permit the collection of
public comments to consider and use in
this proceeding, as appropriate. The
Commission will consider all timely
and responsive public comments it
receives on or before January 3, 2022.
For information on the Commission’s
privacy policy, including routine uses
permitted by the Privacy Act, see
https://www.ftc.gov/site-information/
privacy-policy.
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
68669
Analysis of Agreement Containing
Consent Orders To Aid Public Comment
The Federal Trade Commission
(‘‘Commission’’) has accepted, subject to
final approval, an Agreement
Containing Consent Orders (‘‘Consent
Agreement’’) from ANI Pharmaceuticals,
Inc. (‘‘ANI’’) and Novitium Pharma LLC
and Esjay LLC (collectively,
‘‘Novitium’’) designed to remedy the
anticompetitive effects resulting from
ANI’s acquisition of the non-corporate
interests of Novitium. Pursuant to an
agreement dated March 8, 2021, ANI
proposes to acquire Novitium in a
transaction valued at approximately
$210 million. 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 following two
U.S. markets: (1) Generic SMX–TMP
oral suspension; and (2) generic
dexamethasone tablets. 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’’),
Respondents are required to divest all of
ANI’s rights and assets related to the
following two products to Prasco LLC
(‘‘Prasco’’): (1) Generic
sulfamethoxazole-trimethoprim (‘‘SMX–
TMP’’) oral suspension; and (2) generic
dexamethasone tablets. The
Commission and Respondents have
agreed to an Order to Maintain Assets
that requires Respondents to operate
and maintain each divestiture product
in the normal course of business until
the products are ultimately divested to
Prasco. The Commission also issued the
Order to Maintain Assets.
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 ANI is a public specialty
pharmaceutical company headquartered
in Baudette, Minnesota selling both
branded and generic pharmaceutical
products.
E:\FR\FM\03DEN1.SGM
03DEN1
68670
Federal Register / Vol. 86, No. 230 / Friday, December 3, 2021 / Notices
Respondent Novitium is a privatelyheld company based in East Windsor,
New Jersey. The company develops,
manufactures, and commercializes
generic pharmaceutical products.
jspears on DSK121TN23PROD with NOTICES1
II. The Products and Structure of the
Markets
In human pharmaceutical markets,
price(s) generally decreases as the
number of generic competitors increase.
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 SMX–
TMP oral suspension market, where
ANI is a current competitor and
Novitium is likely to enter the market.
Generic SMX–TMP oral suspension is
an antibiotic product used to treat a
variety of infections. Five companies,
including ANI, currently market the
product in the United States, but at least
one has had difficulty manufacturing
the product. Novitium is one of a
limited number of suppliers capable of
entering the market for SMX–TMP oral
suspension in the near future.
Similarly, the Proposed Acquisition
would reduce future competition in the
4 mg strength of generic dexamethasone
tablets market, where both ANI and
Novitium are likely to enter the market
in the near future. Generic
dexamethasone tablets are an oral
steroid product used to treat
inflammation associated with a variety
of conditions. Dexamethasone tablets
are available in a variety of strengths,
although the most widely used strength
is the 4 mg strength. Only two
companies sell the 4 mg strength of
dexamethasone tablets in the United
States today, and ANI and Novitium are
two of a limited number of companies
likely to enter the market in the near
future.
III. Entry
Entry into the two markets 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 Proposed Acquisition likely
would delay or reduce the introduction
of beneficial competition, and
VerDate Sep<11>2014
18:06 Dec 02, 2021
Jkt 256001
subsequent price decreases, by
eliminating future competition in the
two markets at issue. While five
companies, including ANI, currently
market the generic SMX–TMP product
in the United States, at least one has had
difficulty manufacturing the product,
and Novitium is one of a limited
number of suppliers capable of entering
the market in the near future. In the
generic dexamethasone tablets market,
only two companies sell the 4 mg
strength in the United States today and
ANI and Novitium are two of a limited
number of companies entering the
market in the near future. Absent a
remedy, the Proposed Acquisition likely
would cause U.S. consumers to pay
higher prices for the aforementioned
generic products.
V. The Proposed Order and the Order
To Maintain Assets
The proposed Order and the Order to
Maintain Assets effectively remedy the
competitive concerns raised by the
Proposed Combination for the two
generic pharmaceutical product areas at
issue. Pursuant to the proposed Order,
the parties are required to divest ANI’s
rights and assets related to the two
products to Prasco. The parties must
accomplish these divestitures no later
than ten days after the Proposed
Combination is consummated. The
proposed Order further allows the
Commission to appoint a trustee in the
event the parties fail to divest the
products.
While ANI and Novitium do not
compete again each other in the market
for generic erythromycin and
ethylsuccinate granules for oral
suspension, Novitium has an
unexecuted option to acquire a product
from another company and ANI sells a
product today. The proposed Order
requires prior Commission approval
before ANI or Novitium may acquire
any rights or interests in certain
products containing, as the active
pharmaceutical ingredients,
erythromycin and ethylsuccinate. This
provision allows the Commission to
evaluate whether a future acquisition of
the erythromycin and ethylsuccinate
product would reduce competition at
the time the acquisition is proposed.
The proposed Order also requires ANI
and Novitium to seek Commission
approval before acquiring any other
SMX–TMP or dexamethasone tablet
product.
The Commission’s goal in evaluating
possible purchasers of divested assets is
to maintain the competitive
environment that existed prior to the
Proposed Combination. Prasco is a
capable purchaser with management
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
and employees who have experience
marketing and distributing generic
pharmaceutical products. It will be able
to replicate the competition otherwise
lost from the Proposed Combination.
The proposed Order contains several
provisions to help ensure the
divestitures are successful. ANI will
supply Prasco with SMX–TMP oral
suspension and dexamethasone tablets
for up to three years while the company
transfers the manufacturing technology
to Prasco’s contract manufacturing
designee. The proposed Order also
requires ANI to provide transitional
services to Prasco to assist it in
establishing its manufacturing
capabilities and securing all of the
necessary FDA approvals. These
transitional services include technical
assistance to have the products
manufactured in substantially the same
manner and quality employed or
achieved by ANI. It also includes advice
and training from knowledgeable
employees of the parties. Further, the
proposed Order requires prior
Commission approval before Prasco may
sell, license, or otherwise convey any of
the assets divested pursuant to the
proposed Order.
Under the proposed Order, the
Commission also will appoint a Monitor
to ensure ANI and Novitium comply
with their obligations under the
proposed Order and Order to Maintain
Assets. The Commission has appointed
Denise Smart of Smart Consulting
Group, LLC as the Monitor. Ms. Smart
is an expert in areas such as
pharmaceutical R&D, regulatory
approval, manufacturing and supply,
and marketing, and she has over thirty
years of experience in the
pharmaceutical area and has provided
consulting services in healthcare
business development to major
pharmaceutical companies,
biotechnology companies, universities,
and other government agencies,
including the FDA, Department of
Defense, and Health and Human
Services.
The proposed Order also contains a
prior approval provision relating to
Prasco, which prohibits Prasco from
selling the acquired products for a
combined period of ten years after the
Order is issued, except to an acquirer
that receives the prior approval of the
Commission.
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
E:\FR\FM\03DEN1.SGM
03DEN1
Federal Register / Vol. 86, No. 230 / Friday, December 3, 2021 / Notices
Order and does not modify its terms in
any way.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
By direction of the Commission.
April J. Tabor,
Secretary.
Centers for Disease Control and
Prevention
[FR Doc. 2021–26294 Filed 12–2–21; 8:45 am]
Board of Scientific Counselors,
National Center for Health Statistics
(BSC, NCHS)
BILLING CODE 6750–01–P
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice of meeting.
AGENCY:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
jspears on DSK121TN23PROD with NOTICES1
Notice is hereby given of a change in
the meeting of the Disease, Disability,
and Injury Prevention and Control
Special Emphasis Panel (SEP)—RFA–
CK–22–003, Emerging Infections
Sentinel Networks (EISN) Research;
January 11, 2022, 10:00 a.m.–5:00 p.m.,
EST, Teleconference, Centers for
Disease Control and Prevention, Room
1080, 8 Corporate Square Boulevard,
Atlanta, Georgia 30329–4027, in the
original FRN. The meeting was
published in the Federal Register on
November 8, 2021, Volume 86, Number
213, page 61767.
The meeting is being amended to
change the contact information and
should read as follows:
FOR FURTHER INFORMATION CONTACT:
Gregory Anderson, M.S., M.P.H.,
Scientific Review Officer, National
Center for HIV, Viral Hepatitis, STD,
and TB Prevention, CDC, 1600 Clifton
Road NE, Mailstop US8–1, Atlanta,
Georgia 30329–4027, Telephone: (404)
718–8833; Email: GAnderson@cdc.gov.
The meeting is closed to the public.
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. 2021–26298 Filed 12–2–21; 8:45 am]
BILLING CODE 4163–18–P
VerDate Sep<11>2014
18:06 Dec 02, 2021
Jkt 256001
In accordance with the
Federal Advisory Committee Act, the
CDC announces the following meeting
for the Board of Scientific Counselors,
National Center for Health Statistics
(BSC, NCHS). This meeting is open to
the public.
DATES: The meeting will be held on
February 10, 2022, from 11:00 a.m. to
5:15 p.m., EST (times subject to change).
ADDRESSES: Instructions to access the
meeting are posted here: https://
www.cdc.gov/nchs/about/bsc/bsc_
meetings.htm.
SUMMARY:
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP)—RFA–CK–22–
003, Emerging Infections Sentinel
Networks (EISN) Research; Amended
Notice of Meeting
68671
are subject to change as priorities
dictate.
Meeting Information: Please visit the
BSC website for details: https://
www.cdc.gov/nchs/about/bsc/bsc_
meetings.htm for more information on
the meeting agenda, including
instructions for accessing the live
meeting broadcast.
The Board will reserve time for public
comment at the end of the day.
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. 2021–26317 Filed 12–2–21; 8:45 am]
BILLING CODE 4163–18–P
FOR FURTHER INFORMATION CONTACT:
Rebecca Hines, M.H.S., Executive
Secretary, NCHS/CDC, Board of
Scientific Counselors, 3311 Toledo
Road, Room 2627, Hyattsville, Maryland
20782, Telephone: (301) 458–4717;
Email: RSHines@cdc.gov.
SUPPLEMENTARY INFORMATION:
Purpose: The Board is charged with
providing advice and making
recommendations to the Secretary,
Department of Health and Human
Services; the Director, CDC; and the
Director, NCHS, regarding the scientific
and technical program goals and
objectives, strategies, and priorities of
NCHS.
Matters to be Considered: The
meeting agenda will include welcome
remarks and a Center update by the
NCHS Director; a welcome and
introductions for five new Board
members who will be attending their
first BSC meeting; discussion with
members on plans and potential
revisions to NCHS surveys, including
the addition of new questions; a report
out from the Population Health Survey
Planning, Methodology and Data
Presentation (PHSPMDP) Workgroup on
their assessment of the use of panel
survey data by NCHS; an update on
approaches to enhancing identification
of opioid-Involved hospitalizations with
clinical data and notes from electronic
health records, and; an update on
several NCHS Programs. Agenda items
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
[OMB No. 0970–0167]
Proposed Information Collection
Activity; ACF–801: Child Care and
Development Fund (CCDF) Quarterly
Case-Level Report
Office of Child Care,
Administration for Children and
Families, HHS.
ACTION: Request for public comment.
AGENCY:
The Office of Child Care
(OCC), Administration for Children and
Families (ACF) is requesting a 3-year
extension of the form ACF–801: CCDF
Quarterly Case-Level Report (OMB
#0970–0167, expiration 2/28/2022).
OCC proposes minor changes to the
response categories under the following
three data elements: Child’s gender,
ethnicity, and race.
DATES: Comments due within 60 days of
publication. In compliance with the
requirements of the Paperwork
Reduction Act of 1995, ACF is soliciting
public comment on the specific aspects
of the information collection described
above.
SUMMARY:
E:\FR\FM\03DEN1.SGM
03DEN1
]]>Agencies
[Federal Register Volume 86, Number 230 (Friday, December 3, 2021)]
[Notices]
[Pages 68668-68671]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-26294]
=======================================================================
-----------------------------------------------------------------------
FEDERAL TRADE COMMISSION
[File No. 211 0101/Docket No. C-4754]
ANI/Novitium; Analysis of Agreement Containing Consent Orders To
Aid Public Comment
AGENCY: Federal Trade Commission.
ACTION: Proposed consent agreement; request for comment.
-----------------------------------------------------------------------
SUMMARY: The consent agreement in this matter settles alleged
violations of Federal law prohibiting unfair methods of competition.
The attached Analysis of Proposed Consent Orders to Aid Public Comment
describes both the allegations in the complaint and the terms of the
consent orders--embodied in the consent agreement--that would settle
these allegations.
DATES: Comments must be received on or before January 3, 2022.
ADDRESSES: Interested parties may file comments online or on paper, by
following the instructions in the Request for Comment part of the
SUPPLEMENTARY INFORMATION section below. Please write: ``ANI/Novitium;
File No. 211 0101'' on your comment, and file your comment online at
https://www.regulations.gov by following the instructions on the web-
based form. If you prefer to file your comment on paper, please mail
your comment to the following address: Federal Trade Commission, Office
of the Secretary, 600 Pennsylvania Avenue NW, Suite CC-5610 (Annex D),
Washington, DC 20580; or deliver your comment to the following address:
Federal Trade Commission, Office of the Secretary, Constitution Center,
400 7th Street SW, 5th Floor, Suite 5610 (Annex D), Washington, DC
20024.
[[Page 68669]]
FOR FURTHER INFORMATION CONTACT: Kari Wallace (202-326-3085), Bureau of
Competition, Federal Trade Commission, 400 7th Street SW, Washington,
DC 20024.
SUPPLEMENTARY INFORMATION: Pursuant to Section 6(f) of the Federal
Trade Commission Act, 15 U.S.C. 46(f), and FTC Rule 2.34, 16 CFR 2.34,
notice is hereby given that the above-captioned consent agreement
containing a consent order to cease and desist, having been filed with
and accepted, subject to final approval, by the Commission, has been
placed on the public record for a period of thirty (30) days. The
following Analysis of Agreement Containing Consent Orders to Aid Public
Comment describes the terms of the consent agreement and the
allegations in the complaint. An electronic copy of the full text of
the consent agreement package can be obtained from the FTC website at
this web address: https://www.ftc.gov/news-events/commission-actions.
You can file a comment online or on paper. For the Commission to
consider your comment, we must receive it on or before January 3, 2022.
Write ``ANI/Novitium; File No. 211 0101'' on your comment. Your
comment--including your name and your state--will be placed on the
public record of this proceeding, including, to the extent practicable,
on the https://www.regulations.gov website.
Due to protective actions in response to the COVID-19 pandemic and
the agency's heightened security screening, postal mail addressed to
the Commission will be delayed. We strongly encourage you to submit
your comments online through the https://www.regulations.gov website.
If you prefer to file your comment on paper, write ``ANI/Novitium;
File No. 211 0101'' on your comment and on the envelope, and mail your
comment to the following address: Federal Trade Commission, Office of
the Secretary, 600 Pennsylvania Avenue NW, Suite CC-5610 (Annex D),
Washington, DC 20580; or deliver your comment to the following address:
Federal Trade Commission, Office of the Secretary, Constitution Center,
400 7th Street SW, 5th Floor, Suite 5610 (Annex D), Washington, DC
20024. If possible, submit your paper comment to the Commission by
courier or overnight service.
Because your comment will be placed on the publicly accessible
website at https://www.regulations.gov, you are solely responsible for
making sure your comment does not include any sensitive or confidential
information. In particular, your comment should not include sensitive
personal information, such as your or anyone else's Social Security
number; date of birth; driver's license number or other state
identification number, or foreign country equivalent; passport number;
financial account number; or credit or debit card number. You are also
solely responsible for making sure your comment does not include
sensitive health information, such as medical records or other
individually identifiable health information. In addition, your comment
should not include any ``trade secret or any commercial or financial
information which . . . is privileged or confidential''--as provided by
Section 6(f) of the FTC Act, 15 U.S.C. 46(f), and FTC Rule 4.10(a)(2),
16 CFR 4.10(a)(2)--including in particular competitively sensitive
information such as costs, sales statistics, inventories, formulas,
patterns, devices, manufacturing processes, or customer names.
Comments containing material for which confidential treatment is
requested must be filed in paper form, must be clearly labeled
``Confidential,'' and must comply with FTC Rule 4.9(c). In particular,
the written request for confidential treatment that accompanies the
comment must include the factual and legal basis for the request, and
must identify the specific portions of the comment to be withheld from
the public record. See FTC Rule 4.9(c). Your comment will be kept
confidential only if the General Counsel grants your request in
accordance with the law and the public interest. Once your comment has
been posted on https://www.regulations.gov--as legally required by FTC
Rule 4.9(b)--we cannot redact or remove your comment from that website,
unless you submit a confidentiality request that meets the requirements
for such treatment under FTC Rule 4.9(c), and the General Counsel
grants that request.
Visit the FTC website at https://www.ftc.gov to read this Notice
and the news release describing this matter. The FTC Act and other laws
the Commission administers permit the collection of public comments to
consider and use in this proceeding, as appropriate. The Commission
will consider all timely and responsive public comments it receives on
or before January 3, 2022. For information on the Commission's privacy
policy, including routine uses permitted by the Privacy Act, see
https://www.ftc.gov/site-information/privacy-policy.
Analysis of Agreement Containing Consent Orders To Aid Public Comment
The Federal Trade Commission (``Commission'') has accepted, subject
to final approval, an Agreement Containing Consent Orders (``Consent
Agreement'') from ANI Pharmaceuticals, Inc. (``ANI'') and Novitium
Pharma LLC and Esjay LLC (collectively, ``Novitium'') designed to
remedy the anticompetitive effects resulting from ANI's acquisition of
the non-corporate interests of Novitium. Pursuant to an agreement dated
March 8, 2021, ANI proposes to acquire Novitium in a transaction valued
at approximately $210 million. 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 following two U.S. markets: (1) Generic SMX-
TMP oral suspension; and (2) generic dexamethasone tablets. 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''),
Respondents are required to divest all of ANI's rights and assets
related to the following two products to Prasco LLC (``Prasco''): (1)
Generic sulfamethoxazole-trimethoprim (``SMX-TMP'') oral suspension;
and (2) generic dexamethasone tablets. The Commission and Respondents
have agreed to an Order to Maintain Assets that requires Respondents to
operate and maintain each divestiture product in the normal course of
business until the products are ultimately divested to Prasco. The
Commission also issued the Order to Maintain Assets.
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 ANI is a public specialty pharmaceutical company
headquartered in Baudette, Minnesota selling both branded and generic
pharmaceutical products.
[[Page 68670]]
Respondent Novitium is a privately-held company based in East
Windsor, New Jersey. The company develops, manufactures, and
commercializes generic pharmaceutical products.
II. The Products and Structure of the Markets
In human pharmaceutical markets, price(s) generally decreases as
the number of generic competitors increase. 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
SMX-TMP oral suspension market, where ANI is a current competitor and
Novitium is likely to enter the market. Generic SMX-TMP oral suspension
is an antibiotic product used to treat a variety of infections. Five
companies, including ANI, currently market the product in the United
States, but at least one has had difficulty manufacturing the product.
Novitium is one of a limited number of suppliers capable of entering
the market for SMX-TMP oral suspension in the near future.
Similarly, the Proposed Acquisition would reduce future competition
in the 4 mg strength of generic dexamethasone tablets market, where
both ANI and Novitium are likely to enter the market in the near
future. Generic dexamethasone tablets are an oral steroid product used
to treat inflammation associated with a variety of conditions.
Dexamethasone tablets are available in a variety of strengths, although
the most widely used strength is the 4 mg strength. Only two companies
sell the 4 mg strength of dexamethasone tablets in the United States
today, and ANI and Novitium are two of a limited number of companies
likely to enter the market in the near future.
III. Entry
Entry into the two markets 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 Proposed Acquisition likely would delay or reduce the
introduction of beneficial competition, and subsequent price decreases,
by eliminating future competition in the two markets at issue. While
five companies, including ANI, currently market the generic SMX-TMP
product in the United States, at least one has had difficulty
manufacturing the product, and Novitium is one of a limited number of
suppliers capable of entering the market in the near future. In the
generic dexamethasone tablets market, only two companies sell the 4 mg
strength in the United States today and ANI and Novitium are two of a
limited number of companies entering the market in the near future.
Absent a remedy, the Proposed Acquisition likely would cause U.S.
consumers to pay higher prices for the aforementioned generic products.
V. The Proposed Order and the Order To Maintain Assets
The proposed Order and the Order to Maintain Assets effectively
remedy the competitive concerns raised by the Proposed Combination for
the two generic pharmaceutical product areas at issue. Pursuant to the
proposed Order, the parties are required to divest ANI's rights and
assets related to the two products to Prasco. The parties must
accomplish these divestitures no later than ten days after the Proposed
Combination is consummated. The proposed Order further allows the
Commission to appoint a trustee in the event the parties fail to divest
the products.
While ANI and Novitium do not compete again each other in the
market for generic erythromycin and ethylsuccinate granules for oral
suspension, Novitium has an unexecuted option to acquire a product from
another company and ANI sells a product today. The proposed Order
requires prior Commission approval before ANI or Novitium may acquire
any rights or interests in certain products containing, as the active
pharmaceutical ingredients, erythromycin and ethylsuccinate. This
provision allows the Commission to evaluate whether a future
acquisition of the erythromycin and ethylsuccinate product would reduce
competition at the time the acquisition is proposed. The proposed Order
also requires ANI and Novitium to seek Commission approval before
acquiring any other SMX-TMP or dexamethasone tablet product.
The Commission's goal in evaluating possible purchasers of divested
assets is to maintain the competitive environment that existed prior to
the Proposed Combination. Prasco is a capable purchaser with management
and employees who have experience marketing and distributing generic
pharmaceutical products. It will be able to replicate the competition
otherwise lost from the Proposed Combination.
The proposed Order contains several provisions to help ensure the
divestitures are successful. ANI will supply Prasco with SMX-TMP oral
suspension and dexamethasone tablets for up to three years while the
company transfers the manufacturing technology to Prasco's contract
manufacturing designee. The proposed Order also requires ANI to provide
transitional services to Prasco to assist it in establishing its
manufacturing capabilities and securing all of the necessary FDA
approvals. These transitional services include technical assistance to
have the products manufactured in substantially the same manner and
quality employed or achieved by ANI. It also includes advice and
training from knowledgeable employees of the parties. Further, the
proposed Order requires prior Commission approval before Prasco may
sell, license, or otherwise convey any of the assets divested pursuant
to the proposed Order.
Under the proposed Order, the Commission also will appoint a
Monitor to ensure ANI and Novitium comply with their obligations under
the proposed Order and Order to Maintain Assets. The Commission has
appointed Denise Smart of Smart Consulting Group, LLC as the Monitor.
Ms. Smart is an expert in areas such as pharmaceutical R&D, regulatory
approval, manufacturing and supply, and marketing, and she has over
thirty years of experience in the pharmaceutical area and has provided
consulting services in healthcare business development to major
pharmaceutical companies, biotechnology companies, universities, and
other government agencies, including the FDA, Department of Defense,
and Health and Human Services.
The proposed Order also contains a prior approval provision
relating to Prasco, which prohibits Prasco from selling the acquired
products for a combined period of ten years after the Order is issued,
except to an acquirer that receives the prior approval of the
Commission.
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
[[Page 68671]]
Order and does not modify its terms in any way.
By direction of the Commission.
April J. Tabor,
Secretary.
[FR Doc. 2021-26294 Filed 12-2-21; 8:45 am]
BILLING CODE 6750-01-P
