Federal Register / Vol. 89, No. 227 / Monday, November 25, 2024 / Notices 92935 

PICOTS (POPULATIONS, INTERVENTIONS, COMPARATORS, OUTCOMES, TIMING, AND SETTING)—Continued 

[Study eligibility criteria based on Population, Intervention, Comparator, Outcome (PICO), and other elements] 

Element Inclusion criteria Exclusion criteria 

Key Question 2 .................................................

• Studies of adults 

Æ Parallel or cross-over RCTs 

D n ≥25/group * 

Æ Nonrandomized comparative studies 

D Must account for potential confounders.

D Dietary intake must be defined or 

described prospectively.

D We will aim for a minimum of about 

10 observational studies for each 

specific intervention—CV event 

pair (e.g., reduced saturated fat 

and stroke). We will thus select the 

largest observational studies within 

each category.†.

D n ≥100/group.

Timing ................................................................ Key Question 1 ................................................. None. 

• Minimum intervention length: 4 weeks .........

• In cross-over studies, any change in outcome measure must exclude data from the 

first week after end of any prior treatments 

Key Question 2 .................................................

• Minimum follow-up 

Æ If population has no CV risk factors: 10 

years.

Æ If population has one or more CV risk 

factors (or unselected general population): 5 years.

Setting ................................................................ • General community settings, including nursing homes, assisted living facilities, etc.• Hospital or other acute care settings. 

• Institutionalized, confined settings (e.g., 

prisons) 

Publication ......................................................... • English language 

• Published in peer-reviewed journals.

* Minimum sample size may be altered depending on the number of eligible studies found. 

† Applying this approach for the 2016 AHRQ report n-3 fatty acids and cardiovascular disease (https://doi.org/10.23970/AHRQEPCERTA223), 

we included: for cardiac event outcomes, observational studies with at least 10,000 participants; for stroke outcomes, at least 3000 participants; 

for arrhythmia outcomes, at least 2000 participants; congestive heart failure outcomes, at least 700 participants; and for peripheral vascular disease events and MACE outcomes, at least 500 participants. In all instances, if a study meets eligibility criteria for any outcome, we will extract all 

outcomes of interest from that study; therefore, there will be multiple instances of studies being included for an outcome even though the study 

might not have met study size criteria for that specific outcome. 

CV = cardiovascular; CVD = cardiovascular disease; MUFA = mono-unsaturated fatty acids; PUFA = polyunsaturated fatty acids; c = cholesterol; LDL = low-density lipoprotein; IDL = intermediate-density lipoprotein; HDL high-density lipoprotein; TC—total cholesterol; Tg = Triglycerides/ 

Triacylglycerols; apoA = apolipoprotein; MAC[C]E = Major adverse cardiac (or cerebro) events; BMI = body mass index; KQ = key question; N = 

number of participants. 

Dated: November 19, 2024. 

Marquita Cullom, 

Associate Director. 

[FR Doc. 2024–27488 Filed 11–22–24; 8:45 am] 

BILLING CODE 4160–90–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Toxic Substances and 

Disease Registry 

[30Day–25–0047] 

Agency Forms Undergoing Paperwork 

Reduction Act Review 

In accordance with the Paperwork 

Reduction Act of 1995, the Agency for 

Toxic Substances and Disease Registry 

(ATSDR) has submitted the information 

collection request titled ‘‘Generic 

Clearance for the Collection of 

Qualitative Feedback on Agency Service 

Delivery’’ to the Office of Management 

and Budget (OMB) for review and 

approval. ATSDR previously published 

a ‘‘Proposed Data Collection Submitted 

for Public Comment and 

Recommendations’’ notice on August 

16, 2024, to obtain comments from the 

public and affected agencies. ATSDR 

did not receive comments related to the 

previous notice. This notice serves to 

allow an additional 30 days for public 

and affected agency comments. 

ATSDR 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, 


khammond on DSK9W7S144PROD with NOTICES
92936 Federal Register / Vol. 89, No. 227 / Monday, November 25, 2024 / Notices 

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 

Generic Clearance for the Collection 

of Qualitative Feedback on Agency 

Service Delivery (OMB Control No. 

0923–0047, Expiration Date 2/28/ 

2025)—Extension—Agency for Toxic 

Substances and Disease Registry 

(ATSDR). 

Background and Brief Description 

The information collection activity 

provides a means to garner qualitative 

customer and stakeholder feedback in 

an efficient, timely manner, in 

accordance with the Federal 

government’s commitment to improving 

service delivery. By qualitative feedback 

we mean information that provides 

useful insights on perceptions and 

opinions, but are not statistical surveys 

that yield quantitative results that can 

be generalized to the population of 

study. 

This feedback will provide insights 

into customer or stakeholder 

perceptions, experiences, and 

expectations, provide an early warning 

of issues with service, or focus attention 

on areas where communication, training 

or changes in operations might improve 

delivery of products or services. These 

collections will allow for ongoing, 

collaborative, and actionable 

communications between the ATSDR 

and its customers and stakeholders. It 

will also allow feedback to contribute 

directly to the improvement of program 

management. 

The solicitation of feedback will target 

areas such as: timeliness, 

appropriateness, accuracy of 

information, courtesy, efficiency of 

service delivery, and resolution of 

issues with service delivery. Responses 

will be assessed to plan and inform 

efforts to improve or maintain the 

quality of service offered to the public. 

If this information is not collected, vital 

feedback from customers and 

stakeholders on the Agency’s services 

will be unavailable. 

ATSDR will only submit a collection 

for approval under this Generic 

Clearance if it meets the following 

conditions: 

• The collections are voluntary; 

• The collections are low-burden for 

respondents (based on considerations of 

total burden hours, total number of 

respondents, or burden-hours per 

respondent) and are low-cost for both 

the respondents and the Federal 

Government; 

• The collections are 

noncontroversial and do not raise issues 

of concern to other Federal agencies; 

• Any collection is targeted to the 

solicitation of opinions from 

respondents who have experience with 

the program or may have experience 

with the program in the near future; 

• Personally identifiable information 

(PII) is collected only to the extent 

necessary and is not retained; 

• Information gathered is intended to 

be used only internally for general 

service improvement and program 

management purposes and is not 

intended for release outside of the 

agency (if released, the agency must 

indicate the qualitative nature of the 

information); 

• Information gathered will not be 

used for the purpose of substantially 

informing influential policy decisions; 

and 

• Information gathered will yield 

qualitative information; the collections 

will not be designed or expected to 

yield statistically reliable results or used 

as though the results are generalizable to 

the population of study. 

Feedback collected under this Generic 

Clearance provides useful information, 

but it does not yield data that can be 

generalized to the overall population. 

This type of Generic Clearance for 

qualitative information will not be used 

for quantitative information collections 

that are designed to yield reliably 

actionable results, such as monitoring 

trends over time or documenting 

program performance. Such data uses 

require more rigorous designs that 

address: (1) the target population to 

which generalizations will be made; (2) 

the sampling frame; (3) the sample 

design (including stratification and 

clustering); (4) the precision 

requirements or power calculations that 

justify the proposed sample size; (5) the 

expected response rate; (6) the methods 

for assessing potential nonresponse bias; 

(7) the protocols for data collection; and 

(8) any testing procedures that were or 

will be undertaken prior to fielding the 

study. Depending on the degree of 

influence the results are likely to have, 

such collections may still be eligible for 

submission for other generic 

mechanisms that are designed to yield 

quantitative results. As a general matter, 

information collections will not result 

in any new system of records containing 

privacy information and will not ask 

questions of a sensitive nature, such as 

sexual behavior and attitudes, religious 

beliefs, and other matters that are 

commonly considered private. 

This is an Extension of the previously 

approved collection. The respondents 

are Individuals and Households; 

Businesses and Organizations; and 

State, Local, or Tribal Government. 

ATSDR requests OMB approval for an 

estimated 7,075 annualized burden 

hours. There is no cost to respondents 

other than their time. 

Estimated Annualized Burden Hours 

Type of collection Number of 

respondents 

Annual 

frequency per 

response 

Hours per 

response 

Small discussion groups .............................................................................................................. 300 1 90/60 

Request for customer comment cards/complaint forms/post-conference or training surveys .... 1,500 1 15/60 

Focus groups of customers, potential customers, delivery partners, or other stakeholders ...... 2,000 1 2 

Qualitative customer satisfaction surveys or interviews .............................................................. 3,000 1 30/60 

Usability testing/in-person observation testing ............................................................................ 1,500 1 30/60 


khammond on DSK9W7S144PROD with NOTICES
Federal Register / Vol. 89, No. 227 / Monday, November 25, 2024 / Notices 92937 

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. 2024–27468 Filed 11–22–24; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60Day–25–1255; Docket No. CDC–2024– 

0096] 

Proposed Data Collection Submitted 

for Public Comment and 

Recommendations 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Notice with comment period. 

SUMMARY: The Centers for Disease 

Control and Prevention (CDC), as part of 

its continuing effort to reduce public 

burden and maximize the utility of 

government information, invites the 

general public and other Federal 

agencies the opportunity to comment on 

a continuing information collection, as 

required by the Paperwork Reduction 

Act of 1995. This notice invites 

comment on a proposed information 

collection project titled Emergency 

Cruise Ship Outbreak Investigations 

(CSOIs). The Vessel Sanitation Program 

(VSP) conducts CSOIs in response to 

acute gastroenteritis (AGE) outbreaks on 

cruise ships within the VSP’s 

jurisdiction. 

DATES: CDC must receive written 

comments on or before January 24, 

2025. 

ADDRESSES: You may submit comments, 

identified by Docket No. CDC–2024– 

0096 by either of the following methods: 

• Federal eRulemaking Portal: 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Mail: Jeffrey M. Zirger, Information 

Collection Review Office, Centers for 

Disease Control and Prevention, 1600 

Clifton Road NE, MS H21–8, Atlanta, 

Georgia 30329. 

Instructions: All submissions received 

must include the agency name and 

Docket Number. CDC will post, without 

change, all relevant comments to 

www.regulations.gov. 

Please note: Submit all comments 

through the Federal eRulemaking portal 

(www.regulations.gov) or by U.S. mail to 

the address listed above. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the information collection plan and 

instruments, contact Jeffrey M. Zirger, 

Information Collection Review Office, 

Centers for Disease Control and 

Prevention, 1600 Clifton Road NE, MS 

H21–8, Atlanta, Georgia 30329; 

telephone: 404–639–7570; email: omb@

cdc.gov. 

SUPPLEMENTARY INFORMATION: Under the 

Paperwork Reduction Act of 1995 (PRA) 

(44 U.S.C. 3501–3520), Federal agencies 

must obtain approval from the Office of 

Management and Budget (OMB) for each 

collection of information they conduct 

or sponsor. In addition, the PRA also 

requires Federal agencies to provide a 

60-day notice in the Federal Register 

concerning each proposed collection of 

information, including each new 

proposed collection, each proposed 

extension of existing collection of 

information, and each reinstatement of 

previously approved information 

collection before submitting the 

collection to the OMB for approval. To 

comply with this requirement, we are 

publishing this notice of a proposed 

data collection as described below. 

The OMB is particularly interested in 

comments that will help: 

1. 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; 

2. Evaluate the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used; 

3. Enhance the quality, utility, and 

clarity of the information to be 

collected; 

4. 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 submissions 

of responses; and 

5. Assess information collection costs. 

Proposed Project 

Emergency Cruise Ship Outbreak 

Investigations (CSOIs (OMB Control No. 

0920–1255, Exp. 3/31/2025)— 

Extension—National Center for 

Environmental Health (NCEH), Centers 

for Disease Control and Prevention 

(CDC). 

Background and Brief Description 

Established in 1975 as a cooperative 

activity with the cruise ship industry, 

the Centers for Disease Control and 

Prevention (CDC) Vessel Sanitation 

Program (VSP) develops and 

implements comprehensive operational 

public health programs to minimize the 

risk of gastrointestinal illness. VSP 

coordinates and conducts public health 

inspections, ongoing surveillance of 

gastrointestinal illness, and outbreak 

investigations on cruise ships. 

Under the authority of the Public 

Health Service Act (42 U.S.C. 264 and 

269), VSP is requesting a three-year 

Extension Information Collection 

Request (ICR) for an existing Generic 

Clearance. This ICR will provide for the 

quick turnaround necessary to conduct 

emergency Cruise Ship Outbreak 

Investigations (CSOIs) in response to 

acute gastroenteritis (AGE) outbreaks. 

CSOIs are used to determine causative 

agents and their sources, modes of 

transmission, or risk factors. VSP’s 

jurisdiction includes passenger vessels 

carrying 13 or more people sailing from 

foreign ports and within 15 days of 

arriving at a U.S. port. 

VSP uses its syndromic surveillance 

system called the Maritime Illness and 

Death Reporting System (MIDRS) (OMB 

Control No. 0920–1260, expiration date 

03/31/2026) to collect aggregate data 

about the number of people onboard 

ships in VSP’s jurisdiction who are 

experiencing AGE symptoms. When the 

levels of illness meet VSP’s alert 

threshold (i.e., at least 2% in either the 

passenger or crew populations), a 

special report is made to VSP via 

MIDRS and VSP provides 

environmental health and 

epidemiologic assistance. VSP considers 

an outbreak to be ≥3% of reportable 

AGE cases in either passenger or crew 

populations. 

When a cruise ship has an AGE 

outbreak, VSP often must deploy a 

response team to meet the ship in port 

within 24 hours of reaching the 

outbreak threshold. In some cases, the 

response team must board the ship 

before its U.S. arrival and sail back to 

the U.S. port of disembarkation to 

conduct a more detailed and 

comprehensive epidemiologic and 

environmental health evaluation of the 

outbreak. 

VSP can ascertain a causative agent, 

sources of exposure, modes of 

transmission, and risk factors by 

gathering the following types of 

information from both the affected and 

(seemingly) unaffected populations: 

• Demographic information, 

• Pre-embarkation travel information, 

• Symptoms, including type, onset, 

duration, 

• Contact with people who were sick 

or their body fluids, 


khammond on DSK9W7S144PROD with NOTICES