Federal Register / Vol. 88, No. 176 / Wednesday, September 13, 2023 / Notices 62791 

11 Any suspicions of order violations by Amgen 

may be submitted to the Bureau of Competition by 

email at antitrust@ftc.gov. 

12 Statement of the Commission on Use of Prior 

Approval Provisions in Merger Orders, Fed. Trade 

Comm’n (Oct. 25, 2021), https://www.ftc.gov/ 

system/files/documents/public_statements/ 

1597894/p859900priorapprovalstatement.pdf. 

13 U.S. Dep’t of Justice and Fed. Trade Comm’n, 

Merger Guidelines: Draft for Public Comment 

Purposes (July 19, 2023), https://www.ftc.gov/ 

system/files/ftc_gov/pdf/p859910draftmerger

guidelines2023.pdf; Statement of Chair Lina M. 

Khan Joined by Commissioner Rebecca Kelly 

Slaughter and Commissioner Alvaro M. Bedoya 

Regarding FTC–DOJ Proposed Merger Guidelines 

(July 19, 2023), https://www.ftc.gov/system/files/ 

ftc_gov/pdf/p234000_chair_statement_re_draft_

merger_guidelines.pdf. 

14 Statement of Chair Lina M. Khan Regarding 

6(b) Study of Pharmacy Benefit Managers, 

Commission File No. P221200 (June 8, 2022), 

https://www.ftc.gov/system/files/ftc_gov/pdf/ 

Statement-Khan-6b-Study-Pharmacy-BenefitManagers.pdf; Press Release, Fed. Trade Comm’n, 

FTC Further Expands Inquiry Into Prescription 

Drug Middlemen Industry Practices (June 8, 2023), 

https://www.ftc.gov/news-events/news/pressreleases/2023/06/ftc-further-expands-inquiryprescription-drug-middlemen-industry-practices. 

PBMs preferential placements or 

exclusionary access for its nonblockbuster drugs, thereby excluding 

rivals. This sort of cross-product 

bundling scheme can lock out new 

competitors—even if their products are 

more affordable or effective. Based on 

these facts, the Commission’s complaint 

charged that Amgen’s acquisition of 

Horizon would give Amgen the ability 

and incentive to engage in similar crossproduct bundling that would exclude 

Horizon’s rivals and maintain its 

monopolies, harming patients in the 

long run. 

The order announced today prohibits 

Amgen from engaging in any crossproduct bundling or exclusionary 

rebating schemes involving Horizon’s 

monopoly drugs. Several features of this 

conduct suggest that an order alone can 

effectively halt it. For example, because 

this deal would not give a firm control 

over products or services that its rivals 

use to compete, it does not raise 

traditional concerns about degrading 

competitors’ access to key inputs or 

improper information exchange, which 

can be achieved through subtle and 

varied means that are difficult to detect. 

By contrast, Amgen can only engage in 

exclusionary rebating schemes and 

cross-product bundling in partnership 

with PBMs, who would need to agree to 

accept rebates in exchange for 

privileging Amgen’s drugs or excluding 

those of its rivals. Given the significant 

financial sums involved, these 

agreements would be documented, and 

the FTC’s proposed order will require 

Amgen to regularly submit all such 

agreements and other key documents to 

aid the Commission in identifying even 

implicit efforts to bundle. Amgen is also 

required to notify its trading partners 

about the FTC’s order, ensuring that 

market participants are on alert about 

the prohibited conduct and are 

positioned to report any suspected 

violations.11

The proposed order also prohibits 

Amgen from acquiring any drugs that 

could compete with Horizon’s two 

monopoly drugs without first seeking 

the Commission’s approval. Because 

Amgen could try to neutralize Horizon’s 

rivals not just through excluding them 

but also through acquiring them, this 

prior approval provision will position 

the FTC to block acquisitions that 

would unlawfully maintain Horizon’s 

monopolies.12

Critically, the six state attorneys 

general who joined the FTC’s complaint 

will be able to independently monitor 

Amgen’s compliance with the proposed 

order. California, Illinois, Minnesota, 

New York, Washington, and Wisconsin 

will also have access to Amgen’s 

documents and reports and will serve as 

another key check on any violations. I 

am grateful to our state partners for their 

close collaboration on this enforcement 

matter, and empowering them to 

independently monitor compliance with 

our consent orders—and take corrective 

action as appropriate—positions our 

remedies for greater success. 

The FTC assesses each merger based 

on the specific facts at hand, and there 

is no guarantee that the relief achieved 

in this matter would adequately resolve 

concerns about cross-product bundling 

in any future merger actions. A distinct 

feature of the conduct at issue here is 

that it involves bundling across different 

insurance benefit arrangements, which 

makes it easier to detect. The conduct 

also involves orphan drugs for rare 

diseases, the selection and 

administration of which involves 

providers with incentives to resist and 

report exclusionary behavior. As the 

Commission evaluates proposals to 

settle charges in future pharmaceutical 

mergers, we will continue to learn from 

past experience and seek to fully protect 

the public from deals that violate the 

antitrust laws. The merger guidelines 

we recently proposed with the U.S. 

Department of Justice further describe 

how we will assess transactions to 

determine if they may lessen 

competition or tend to create a 

monopoly.13

Tackling unlawful pharmaceutical 

mergers is just one aspect of the FTC’s 

work addressing high drug prices. The 

bundling and exclusionary rebating 

practices at issue in this matter 

highlight deeper concerns about how 

pharmaceutical companies and 

pharmacy benefit managers may work 

together to deprive Americans of access 

to affordable drugs. The FTC continues 

to scrutinize these practices through its 

inquiry into PBMs.14 And our teams 

will continue to challenge unlawful 

practices that raise drug prices, inhibit 

access, stifle innovation, or otherwise 

hurt patients. 

[FR Doc. 2023–19809 Filed 9–12–23; 8:45 am] 

BILLING CODE 6750–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day–23–1198] 

Agency Forms Undergoing Paperwork 

Reduction Act Review 

In accordance with the Paperwork 

Reduction Act of 1995, the Centers for 

Disease Control and Prevention (CDC) 

has submitted the information 

collection request titled ‘‘Use of the 

Cyclosporiasis National Hypothesis 

Generating Questionnaire (CNHGQ) 

During Investigations of Foodborne 

Disease Clusters and Outbreaks’’ to the 

Office of Management and Budget 

(OMB) for review and approval. CDC 

previously published a ‘‘Proposed Data 

Collection Submitted for Public 

Comment and Recommendations’’ 

notice on July 7, 2023, to obtain 

comments from the public and affected 

agencies. CDC did not receive comments 

related to the previous notice. This 

notice serves to allow an additional 30 

days for public and affected agency 

comments. 

CDC will accept all comments for this 

proposed information collection project. 

The Office of Management and Budget 

is particularly interested in comments 

that: 

(a) Evaluate whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information will have 

practical utility; 

(b) Evaluate the accuracy of the 

agencies estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used; 

(c) Enhance the quality, utility, and 

clarity of the information to be 

collected; 

(d) Minimize the burden of the 

collection of information on those who 


ddrumheller on DSK120RN23PROD with NOTICES1
62792 Federal Register / Vol. 88, No. 176 / Wednesday, September 13, 2023 / Notices 

are to respond, including, through the 

use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology, 

e.g., permitting electronic submission of 

responses; and 

(e) Assess information collection 

costs. 

To request additional information on 

the proposed project or to obtain a copy 

of the information collection plan and 

instruments, call (404) 639–7570. 

Comments and recommendations for the 

proposed information collection should 

be sent within 30 days of publication of 

this notice to www.reginfo.gov/public/ 

do/PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under 30-day Review—Open 

for Public Comments’’ or by using the 

search function. Direct written 

comments and/or suggestions regarding 

the items contained in this notice to the 

Attention: CDC Desk Officer, Office of 

Management and Budget, 725 17th 

Street NW, Washington, DC 20503 or by 

fax to (202) 395–5806. Provide written 

comments within 30 days of notice 

publication. 

Proposed Project 

Use of the Cyclosporiasis National 

Hypothesis Generating Questionnaire 

(CNHGQ) During Investigations of 

Foodborne Disease Clusters and 

Outbreaks (OMB Control No. 0920– 

1198, Exp. 9/30/2023)—Extension— 

National Center for Emerging and 

Zoonotic Infectious Diseases (NCEZID), 

Centers for Disease Control and 

Prevention (CDC). 

Background and Brief Description 

The Centers for Disease Control and 

Prevention (CDC) is requesting a threeyear Paperwork Reduction Act (PRA) 

clearance for an Extension of the 

information collection request (ICR) 

‘‘Use of the Cyclosporiasis National 

Hypothesis Generating Questionnaire 

(CNHGQ) During Investigations of 

Foodborne Disease Clusters and 

Outbreaks’’ (OMB Control No. 0920– 

1198, Exp. Date 09/30/2023). 

An estimated one in six Americans 

per year becomes ill with a foodborne 

disease. Foodborne outbreaks of 

cyclosporiasis, caused by the parasite 

Cyclospora cayetanensis, have been 

reported in the United States since the 

mid-1990s and have been linked to 

various types of fresh produce. During 

the 15-year period from 2000–2014, 31 

U.S. foodborne outbreaks of 

cyclosporiasis were reported; the total 

case count was 1,562. It is likely that 

more cases (and outbreaks) occurred 

than were reported. In addition, because 

of insufficient data, many of the 

reported cases could not be directly 

linked to an outbreak or to a particular 

food vehicle. In recent years, from 2018 

onward the number of cases reported 

annually to CDC has increased 

substantially to over 1,000 cases; 

notably, in 2018 and again in 2019 over 

2,000 cases were reported. 

Collecting the requisite data for the 

initial hypothesis-generating phase of 

investigations of multistate foodborne 

disease outbreaks is associated with 

multiple challenges, including the need 

to have high-quality hypothesisgenerating questionnaire(s) that can be 

used effectively in multijurisdictional 

investigations. Such a questionnaire was 

developed in the past for use in the 

context of foodborne outbreaks caused 

by bacterial pathogens; that 

questionnaire is referred to as the 

Standardized National Hypothesis 

Generating Questionnaire (SNHGQ). 

However, not all of the data elements in 

the SNHGQ are relevant to the parasite 

Cyclospora (e.g., questions about 

consumption of meat and dairy 

products); on the other hand, additional 

data elements (besides those in the 

SNHGQ) are needed to capture 

information pertinent to Cyclospora and 

to fresh produce vehicles of infection. 

Therefore, the Cyclosporiasis National 

Hypothesis Generating Questionnaire 

(CNHGQ) has been developed, by using 

core data elements from the SNHGQ and 

incorporating modifications pertinent to 

Cyclospora. 

The core data elements from the 

SNHGQ were developed by a series of 

working groups comprised of local, 

State, and Federal public health 

partners. Subject matter experts at CDC 

developed the CNHGQ by modifying the 

SNHGQ to include and focus on data 

elements pertinent to Cyclospora/ 

cyclosporiasis. Input also was solicited 

from State public health partners. 

Because relatively few data elements in 

the SNHGQ needed to be modified, a 

full vetting process was determined not 

to be necessary. The CNHGQ has been 

designed for administration over the 

telephone by public health officials, to 

collect data elements from case-patients 

or their proxies. The data that are 

collected will be pooled and analyzed at 

CDC, to generate hypotheses about 

potential vehicles/sources of infection. 

CDC requests OMB approval to collect 

information via the CNHGQ from 

persons who have developed 

symptomatic cases of Cyclospora 

infection during periods in which 

increased numbers of such cases are 

reported (typically, during spring and 

summer months). In part because 

molecular typing methods are not yet 

available for C. cayetanensis, it is 

important to interview all case-patients 

identified during periods of increased 

reporting, to help determine if their 

cases could be part of an outbreak(s). 

The CNHGQ is not expected to entail 

substantial burden for respondents. The 

estimated total annualized burden 

associated with administering the 

CNHGQ is 1875 hours (approximately 

2,500 individuals interviewed × 45 

minutes/response). There will be no 

costs to respondents other than their 

time. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Ill individuals identified with cyclosporiasis .... Cyclosporiasis National Hypothesis Generating Questionnaire.2,500 1 45/60 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 176 / Wednesday, September 13, 2023 / Notices 62793 

Jeffrey M. Zirger, 

Lead, Information Collection Review Office, 

Office of Public Health Ethics and 

Regulations, Office of Science, Centers for 

Disease Control and Prevention. 

[FR Doc. 2023–19708 Filed 9–12–23; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day–23–22GA] 

Agency Forms Undergoing Paperwork 

Reduction Act Review 

In accordance with the Paperwork 

Reduction Act of 1995, the Centers for 

Disease Control and Prevention (CDC) 

has submitted the information 

collection request titled ‘‘Expanding 

PrEP in Communities of Color (EPICC)’’ 

to the Office of Management and Budget 

(OMB) for review and approval. CDC 

previously published a ‘‘Proposed Data 

Collection Submitted for Public 

Comment and Recommendations’’ 

notice on June 13, 2022, to obtain 

comments from the public and affected 

agencies. CDC received four comments 

related to the previous notice. This 

notice serves to allow an additional 30 

days for public and affected agency 

comments. 

CDC will accept all comments for this 

proposed information collection project. 

The Office of Management and Budget 

is particularly interested in comments 

that: 

(a) Evaluate whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information will have 

practical utility; 

(b) Evaluate the accuracy of the 

agencies estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used; 

(c) Enhance the quality, utility, and 

clarity of the information to be 

collected; 

(d) Minimize the burden of the 

collection of information on those who 

are to respond, including, through the 

use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology, 

e.g., permitting electronic submission of 

responses; and 

(e) Assess information collection 

costs. 

To request additional information on 

the proposed project or to obtain a copy 

of the information collection plan and 

instruments, call (404) 639–7570. 

Comments and recommendations for the 

proposed information collection should 

be sent within 30 days of publication of 

this notice to www.reginfo.gov/public/ 

do/PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under 30-day Review—Open 

for Public Comments’’ or by using the 

search function. Direct written 

comments and/or suggestions regarding 

the items contained in this notice to the 

Attention: CDC Desk Officer, Office of 

Management and Budget, 725 17th 

Street NW, Washington, DC 20503 or by 

fax to (202) 395–5806. Provide written 

comments within 30 days of notice 

publication. 

Proposed Project 

Expanding PrEP in Communities of 

Color (EPICC)—New—National Center 

for HIV, Viral Hepatitis, STD, TB 

Prevention (NCHHSTP), Centers for 

Disease Control and Prevention (CDC). 

Background and Brief Description 

The CDC is requesting approval for 36 

months for a data collection titled, 

Expanding PrEP in Communities of 

Color (EPICC). The purpose of this study 

is to implement and evaluate the 

effectiveness of a clinic-based 

intervention that utilizes evidencebased education and support tools to: 

(1) increase provider knowledge of and 

comfort with preexposure prophylaxis 

(PrEP) modalities in clinical practice; 

and (2) improve PrEP adherence among 

young men who have sex with men 

(YMSM). The information collected in 

this study will be used to: (1) describe 

real-world PrEP use including factors 

influencing selection and change of 

PrEP regimens; (2) understand and 

describe barriers and facilitators 

impacting the implementation of new 

PrEP modalities in clinical practice; (3) 

evaluate the feasibility and acceptability 

of the EPICC+ mobile app among YMSM 

on PrEP; and (4) evaluate the feasibility 

and acceptability of implementing a 

provider training. 

This study has two aims: In Aim 1, 

the study team will deliver training to 

health providers that will focus on 

implementation of evidence-based tools 

to enhance the providers’ ability to 

engage in PrEP screening, counseling, 

initiation and to provide support for 

adherence and persistence. The study 

will utilize web-based computerassisted surveys to measure healthcare 

provider knowledge both pre- and posttraining. Post-training and at three 

months, providers will complete a 

patient interaction assessment via 

teleconference and receive personalized 

feedback to assess and enhance their 

tailored motivational interviewing 

skills. 

For Aim 2a, the study will initiate an 

effectiveness-implementation trial with 

400 YMSM to test the effectiveness of 

the EPICC+ intervention package in 

increasing PrEP adherence and 

persistence among YMSM. The 

intervention will utilize a mobile appbased platform, EPICC+, to support 

ongoing participant engagement and 

monitoring, as well as to provide 

additional adherence support. YMSM 

participants will complete quarterly 

web-based computerized assessments 

during the 18-month follow up period. 

The assessments will measure PrEP 

knowledge, usage, and choice, and 

gather information about sexual 

behaviors, HIV status of partners, and 

substance use. YMSM participants will 

be mailed four dried blood spot 

collection kits to measure PrEP 

metabolites (baseline, six, 12, and 18 

months). To further examine the 

participant experience and intervention 

satisfaction, a subset of YMSM 

participants (45) will be invited to 

participate in a web-based exit 

interview at the close of the follow up 

period (18 months). Additionally, study 

staff will collect data to measure mobile 

app use and conduct medical record 

abstractions three times during the 

follow up period (six, 12, and 18 

months). 

In Aim 2b, the study team will 

conduct focus groups with health 

providers from the participating clinics 

to gather feedback on overall 

perceptions about the effectiveness of 

the intervention and the barriers and 

facilitators to implementation of the 

evidence-based tools (EBT) within their 

clinical site. Providers will complete a 

short web-based computer-assisted prefocus group survey prior to the virtual 

two-hour focus group. To describe PrEP 

services implementation at the facility 

level, each participating clinic will 

complete a web-based computerassisted clinic assessment at six-month 

intervals during the three-year data 

collection period (baseline, six, 12, 18, 

24, 30, and 36 months). 

This study will be carried out in nine 

clinics located in Chicago, IL; Bronx, 

New York City, NY; Philadelphia, PA; 

Charlotte, NC; Raleigh, NC; Tuscaloosa, 

AL; Tampa, FL; Orlando, FL; and 

Houston, TX. Aim 1 will include 

healthcare providers from the nine 

clinic sites, all involved in the direct 

delivery of PrEP services. Providers may 

include but are not limited to medical 

doctors, nurses, adherence counselors, 

pharmacists, and social workers. Health 

providers will be recruited via staff 


ddrumheller on DSK120RN23PROD with NOTICES1