Federal Register / Vol. 89, No. 177 / Thursday, September 12, 2024 / Notices 74277 

‘‘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 Minimal Data Necessary for Case Data 

During an Emergency Response—New— 

Office of Public Health Data, 

Surveillance, and Technology 

(OPHDST), Centers for Disease Control 

and Prevention (CDC). 

Background and Brief Description 

During a public health emergency 

response, state, tribal, local, and 

territorial (STLT) health departments 

and CDC need to exchange data on 

confirmed, probable, and suspected 

cases rapidly. Timely notifications of 

cases from STLT to CDC are critical to 

provide situational awareness at the 

federal level to support decision 

making, particularly for public health 

threats that escalate quickly and cross 

jurisdictions. To this end, collecting the 

minimum data necessary will provide 

standardization and consistency among 

technical approaches and Agency-wide 

processes. The harmonization across 

CDC programs and STLTs will reduce 

the burden on STLTs and healthcare 

providers from ad hoc requests for case 

data from CDC programs. 

Section 319D of the Public Health 

Service Act (as amended Through Pub. 

L. 118–35, enacted January 19, 2024) 

states that CDC shall define the 

minimum data necessary as the Agency 

collaborates with STLTs and other 

partners to improve the appropriate near 

real-time electronic transmission of 

interoperable public health data for 

situational awareness and response to 

public health emergencies. In addition, 

the CDC Advisory Committee to the 

Director (ACD) recommends that CDC 

should establish the minimum data 

necessary for core data sources 

including case data to be transmitted to 

CDC from STLTs. 

CDC requests a three-year approval for 

a new Generic Information Collection 

Request (ICR), Clearance for the 

Collection of Minimal Data Necessary 

for Case Data During an Emergency 

Response. This new ICR includes a 

request for approval for CDC to collect 

the minimum data necessary for 

confirmed, probable, and suspected 

cases of any disease or condition that is 

the subject of an emergency response. 

Data may be sent to CDC by STLT 

Health Departments through Data 

Collation and Integration for Public 

Health Event Response (DCIPHER) or 

other automated or non-automated 

mechanisms including but not limited 

to fax, email, secure file upload, and 

data entry to a secure website. 

Data will be used for ongoing 

situational awareness and to monitor 

the occurrence and spread of the disease 

or condition. Other uses may include 

identifying populations or geographic 

areas at high risk; planning prevention 

and control programs and policies; and 

allocating resources appropriately. The 

data may also be used by CDC to obtain 

travel histories and other information to 

describe and manage outbreaks and 

conduct public health follow-up to 

minimize the spread of disease. The 

burden estimates include the time that 

states, territories, freely associated 

states, and cities will incur to submit 

confirmed, probable, and suspected case 

data for diseases or conditions that are 

the subject of an emergency response. 

CDC requests OMB approval for an 

estimated 10,951 annualized burden 

hours for the 60 respondents. There is 

no cost to respondents other than their 

time to participate. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondent Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

States .............................................................. Submission of case data ................................ 50 365 30/60 

Territories ........................................................ Submission of case data ................................ 5 365 30/60 

Freely Associated States ................................ Submission of case data ................................ 3 365 30/60 

Cities ............................................................... Submission of case data ................................ 2 365 30/60 

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. 2024–20717 Filed 9–11–24; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF DEFENSE 

Office of the Secretary 

[Docket ID: DoD–2024–OS–0035] 

Submission for OMB Review; 

Comment Request 

AGENCY: Office of the Under Secretary of 

Defense for Intelligence and Security 

(OUSD(I&S)), Department of Defense 

(DoD). 

ACTION: 30-Day information collection 

notice. 

SUMMARY: The DoD has submitted to the 

Office of Management and Budget 

(OMB) for clearance the following 

proposal for collection of information 

under the provisions of the Paperwork 

Reduction Act. 

DATES: Consideration will be given to all 

comments received by October 15, 2024. 

ADDRESSES: Written 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. 

FOR FURTHER INFORMATION CONTACT: 

Reginald Lucas, (571) 372–7574, 

whs.mc-alex.esd.mbx.dd-dodinformation-collections@mail.mil. 

SUPPLEMENTARY INFORMATION: 

Title; Associated Form; and OMB 

Number: Certificate Pertaining to 

Foreign Interests; SF–328; OMB Control 

Number 0704–0579. 

Type of Request: Revision. 

Number of Respondents: 62,950. 

Responses per Respondent: 1. 

Annual Responses: 62,950. 

Average Burden per Response: 100 

minutes. 

Annual Burden Hours: 104,917. 

Needs and Uses: Information 

collection via the Standard Form (SF) 

328, ‘‘Certificate Pertaining to Foreign 

Interests,’’ is necessary to support the 

execution of 32 CFR part 117, ‘‘National 

Industrial Security Program (NISPOM),’’ 


ddrumheller on DSK120RN23PROD with NOTICES1
74278 Federal Register / Vol. 89, No. 177 / Thursday, September 12, 2024 / Notices 

dated December 21, 2020, or equivalent. 

Executive Order (E.O.) 12829, as 

amended, ‘‘National Industrial Security 

Program (NISP),’’ section 202 (a) 

stipulates that the Secretary of Defense 

serves as the Executive Agent for 

inspecting and monitoring the 

contractors, licensees, and grantees who 

require or will require access to, or who 

store or will store classified information; 

and for determining eligibility for access 

to classified information of contractors, 

licensees, and grantees and their 

respective employees. Section 202 (e) 

also authorizes the Executive Agent to 

issue, after consultation with affected 

agencies, standard forms that will 

promote the implementation of the 

NISP. 

E.O. 12829 was amended by E.O. 

13691, adding the Secretary of 

Homeland Security as the fifth 

Cognizant Security Agency. Section 202 

(d) of E.O. 12829 stipulates that the 

Secretary of Homeland Security may 

determine the eligibility for access to 

Classified National Security Information 

of contractors, licensees and grantees 

and their respective employees under a 

designated critical infrastructure 

protection program, including parties to 

agreements with such programs. The 

Secretary of Homeland Security also 

may inspect and monitor the 

contractors, grantees or licensees and 

facilities or may enter into written 

agreements with the Secretary of 

Defense, as Executive Agent or with the 

office of the Director of Intelligence/ 

Director of Central Intelligence Agency 

to inspect and monitor these programs 

in whole or in part on behalf of the 

Secretary of Homeland Security. The 

specific requirements necessary to 

protect classified information released 

to private industry are found in 

NISPOM; found in DoDI 5220.31 

‘‘National Industrial Security Program 

(NISP),’’ which incorporates and cancels 

DoD Instruction 5220.22, ‘‘National 

Industrial Security Program,’’ March 18, 

2011, as amended. The SF 328 

incorporates its usage for the NISP 

portion of the Classified Critical 

Infrastructure Protection Program as 

stipulated under E.O. 12829, as 

amended by E.O. 13691. Revisions to 

the SF 328 will also incorporate its 

usage under the DoD’s Innovation 

initiative through the DoD Enhanced 

Security Program (DESP), pursuant to 

section 951 of Public Law 114–328 (10 

U.S.C. 1564 note). The DESP is a DoD 

only initiative and is not part of the 

NISP. Companies participating under 

the DESP do not require a DoD contract 

but are required to enter into a 

Memorandum of Agreement. 

Completion of the SF 328 and 

submission of supporting 

documentation (e.g., company or entity 

charter documents, board meeting 

minutes, stock or securities information, 

descriptions of organizational 

structures, contracts, sales, leases and/or 

loan agreements and revenue 

documents, annual reports and income 

statements, etc.) is part of the eligibility 

determination for access to classified 

information and/or issuance of an Entity 

Eligibility Determination (also known as 

a Facility Security Clearance). 

Section 847 of the National Defense 

Authorization Act for Fiscal Year 2020 

(Pub. L. 116–92), ‘‘Mitigating Risks 

Related to Foreign Ownership, Control, 

or Influence of Department of Defense 

Contractors or Subcontractors,’’ requires 

the Secretary for Defense to improve the 

process and procedures for the 

assessment and mitigation of risks 

related to FOCI of contractors and 

subcontractors doing business with the 

DoD, in conjunction with the 

Departments efforts to develop and 

implement an improved analytical 

framework for mitigating risk relating to 

ownership structure, as required by 10 

U.S.C. 2509 and section 847 of Public 

Law 116–92. To fulfill the requirements 

of sec. 847, contractors and 

subcontractors must disclose to DCSA 

their beneficial ownership and whether 

they are under FOCI, and to update 

those disclosures when changes occur to 

information previously provided 

consistent with the requirements of the 

NISPOM. In addition, sec. 847 provides 

for the creation of other measures as 

necessary to be consistent with other 

relevant authorities, including the NISP. 

The Small Business Innovation 

Research and Small Business 

Technology Transfer (SBIR/STTR) 

Extension Act of 2022, Public Law 117– 

183, section 4, ‘‘Foreign Risk 

Management’’ (DoD SBIR/STTR 

programs), requires the head of each 

Federal agency required to establish a 

SBIR or STTR program to implement a 

due diligence program to assess security 

risks presented by small business 

concerns seeking federal awards. These 

security risks includes, among other 

things, foreign interested-related risks. 

The DoD intends to utilize the SF 328 

as the basis for information collection 

for DoD SBIR/STTR program 

participants to disclose their foreign 

interests, and to report any future 

changes, as appropriate. For DoD SBIR/ 

STTR, the DoD will use this form to 

collect information to conduct a riskbased due diligence review and assess 

security risks presented by small 

business concerns seeking a federally 

funded award through the DoD SBIR/ 

STTR programs. The submission will be 

required to be submitted as part of the 

SBIR/STTR solicitation package, and 

details concerning its submission will 

be included in the solicitation 

published to perspective submitters. 

The use of the SF 328 will also be 

required by the forthcoming 

Cybersecurity Maturity Model 

Certification (CMMC) program, which is 

currently in the Rulemaking process 

under 32 CFR part 170. The CMMC 

program will require CMMC Level 2 

Certification Assessments be conducted 

by a CMMC Third Party Assessment 

Organization (C3PAO), accredited by 

the DoD approved CMMC Accreditation 

Body (AB). To be accredited, the CMMC 

AB and all C3PAOs must receive a 

favorable adjudication and not be 

subject to a level of risk from Foreign 

Ownership, Control, or Influence (FOCI) 

as determined by the CMMC Program 

Management Office (PMO). DCSA will 

conduct the FOCI assessments for the 

CMMC AB and C3PAOs after they are 

nominated by the CMMC PMO. 

The multiple authorized uses of this 

form will create uniformity among 

numerous authorities responsible for the 

vetting or review of companies or 

entities for foreign interest-related risks. 

In addition, it will establish more 

consistency among industry concerning 

their basic information submission 

requirements regarding foreign interest 

information. 

The submission of the SF–328, and 

supporting documentation, may be done 

electronically through a government 

approved system of record. 

Affected Public: Business or other for 

profit; Not-for-profit institutions. 

Frequency: On occasion. 

Respondent’s Obligation: Voluntary. 

OMB Desk Officer: Ms. Jasmeet 

Seehra. 

You may also submit comments and 

recommendations, identified by Docket 

ID number and title, by the following 

method: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Instructions: All submissions received 

must include the agency name, Docket 

ID number, and title for this Federal 

Register document. The general policy 

for comments and other submissions 

from members of the public is to make 

these submissions available for public 

viewing on the internet at http://

www.regulations.gov as they are 

received without change, including any 

personal identifiers or contact 

information. 

DoD Clearance Officer: Mr. Reginald 

Lucas. 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 89, No. 177 / Thursday, September 12, 2024 / Notices 74279 

Requests for copies of the information 

collection proposal should be sent to 

Mr. Lucas at whs.mc-alex.esd.mbx.dddod-information-collections@mail.mil. 

Dated: September 4, 2024. 

Aaron T. Siegel, 

Alternate OSD Federal Register Liaison 

Officer, Department of Defense. 

[FR Doc. 2024–20650 Filed 9–11–24; 8:45 am] 

BILLING CODE 6001–FR–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–3945] 

The Food and Drug Administration’s 

Draft Strategy Document on Innovative 

Manufacturing Technologies 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; establishment of a 

public docket; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the publication of a draft 

Strategy Document for public comment 

outlining specific actions FDA will take 

during fiscal years 2023–2027 to 

facilitate the use of innovative 

manufacturing technologies. As part of 

the Prescription Drug User Fee Act 

(PDUFA) Reauthorization Performance 

Goals and Procedures Fiscal Years 

2023–2027 (PDUFA VII), FDA 

committed to advance the use and 

implementation of innovative 

manufacturing. In connection with this 

effort, on June 8, 2023, FDA participated 

in a public workshop on the use of 

innovative manufacturing technologies 

for products regulated by the Center for 

Drug Evaluation and Research (CDER) 

and the Center for Biologics Evaluation 

and Research (CBER), including barriers 

to their adoption. FDA also committed 

to issuing this draft Strategy Document 

for public comment. The actions 

described in the draft Strategy 

Document are based on lessons learned 

from FDA’s experiences with 

submissions involving advanced 

manufacturing technologies as well as 

feedback from the workshop and other 

public input. 

DATES: Either electronic or written 

comments on the draft Strategy 

Document must be submitted by 

November 12, 2024. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

November 12, 2024.Comments received 

by mail/hand delivery/courier (for 

written/paper submissions) will be 

considered timely if they are received 

on or before that date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2024–N–3945 for ‘‘FDA’s Strategy 

Document on Innovative Manufacturing 

Technologies.’’ Received comments, 

those filed in a timely manner (see 

ADDRESSES), will be placed in the docket 

and, except for those submitted as 

‘‘Confidential Submissions,’’ publicly 

viewable at https://www.regulations.gov 

or at the Dockets Management Staff 

between 9 a.m. and 4 p.m., Monday 

through Friday, 240–402–7500. 

• Confidential Submissions: To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

FOR FURTHER INFORMATION CONTACT: 

Elisa A. Nickum, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 75, Rm. 4521, 

Silver Spring, MD 20993, 301–796– 

4226, Elisa.Nickum@fda.hhs.gov; or 

James Myers, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993–0002, 240– 

402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Innovative manufacturing 

technologies—including but not limited 

to continuous manufacturing, 

distributed manufacturing, modern 

aseptic manufacturing equipment, and 


ddrumheller on DSK120RN23PROD with NOTICES1