380 Federal Register / Vol. 89, No. 2 / Wednesday, January 3, 2024 / Notices 

Human Services to serve four-year 

terms. New members are selected each 

year to replace those members who are 

completing their appointments. 

The USPSTF rigorously evaluates the 

effectiveness of clinical preventive 

services and formulating or updating 

recommendations regarding the 

appropriate provision of preventive 

services. Current USPSTF 

recommendations and associated 

evidence reviews are available on the 

internet (www.uspreventiveservices

taskforce.org). 

USPSTF members meet three times a 

year for two days in the Washington, DC 

area or virtually if necessary. A 

significant portion of the USPSTF’s 

work occurs between meetings during 

conference calls and via email 

discussions. Member duties include 

prioritizing topics, designing research 

plans, reviewing and commenting on 

systematic evidence reviews, discussing 

evidence and making recommendations 

on preventive services, reviewing 

stakeholder comments, drafting final 

recommendation documents, and 

participating in workgroups on specific 

topics and methods. Members can 

expect to receive frequent emails, can 

expect to participate in multiple 

conference calls each month, and can 

expect to have periodic interaction with 

stakeholders. AHRQ estimates that 

members devote approximately 250 

hours a year outside of in-person 

meetings to their USPSTF duties. The 

members are all volunteers and do not 

receive any compensation beyond 

support for travel to attend the thrice 

yearly meetings and trainings. 

Dated: December 27, 2023. 

Marquita Cullom, 

Associate Director. 

[FR Doc. 2023–28870 Filed 1–2–24; 8:45 am] 

BILLING CODE 4160–90–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–5653] 

Food and Drug Administration’s Draft 

Report and Plan on Best Practices for 

Guidance; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability, request 

for comments. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a draft 

document entitled ‘‘Food and Drug 

Administration’s Draft Report and Plan 

on Best Practices for Guidance.’’ This 

draft report responds to the 

Consolidated Appropriations Act of 

2023, which directs FDA to issue a 

report identifying best practices for the 

efficient prioritization, development, 

issuance, and use of guidance 

documents and a plan for 

implementation of such best practices. It 

also directs FDA to publish a draft 

report and plan no later than 1 year after 

enactment of the Consolidated 

Appropriations Act and to consult with 

stakeholders in developing the report 

and implementation plan. 

DATES: Submit either electronic or 

written comments on the draft report 

and plan by March 4, 2024. 

ADDRESSES: You may submit comments 

as follows: 

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– 

2023–N–5653 for ‘‘Draft Report and Plan 

on Best Practices for Guidance.’’ 

Received comments 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. 

See the SUPPLEMENTARY INFORMATION

section for electronic access to the draft 

report and plan. 

FOR FURTHER INFORMATION CONTACT: Julie 

Finegan, Office of Policy, Office of the 

Commissioner, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 4252, Silver Spring, 

MD 20993–0002, 301–827–4830. 


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Federal Register / Vol. 89, No. 2 / Wednesday, January 3, 2024 / Notices 381 

1 65 FR 56468 at 56472 (September 19, 2000). 

SUPPLEMENTARY INFORMATION: 

I. Background 

Clear, concise, and timely 

communication through guidance 

documents is essential to the public 

health mission of FDA. FDA guidance 

documents are prepared for regulated 

industry, FDA staff, and the public to 

describe the Agency’s interpretation of, 

or policy on, a regulatory issue. 

(§ 10.115(b) (21 CFR 10.115(b))). Unlike 

statutes and regulations, guidance 

documents generally do not establish 

legally enforceable rights or 

responsibilities (§ 10.115(d)), and are 

thus exempt from notice and comment 

requirements applicable to most 

rulemaking under the Administrative 

Procedure Act. (5 U.S.C. 553(b)(A); 

(d)(2)). However, the Federal Food, 

Drug, and Cosmetic Act (FD&C Act) and 

FDA’s Good Guidance Practices (GGP) 

regulation (§ 10.115) require FDA to 

provide an opportunity for public 

comment prior to implementation for all 

Level 1 guidance documents (i.e., 

guidance documents that include initial 

interpretations of a statute or regulation, 

changes in interpretation or policy that 

are of more than a minor nature, 

complex scientific issues, or highly 

controversial issues), unless FDA 

determines that prior public 

participation is not feasible or 

appropriate. (21 U.S.C.371(h)(1)(C)(i); 

10.115(g)). If FDA decides that public 

participation is not feasible or 

appropriate prior to implementation of 

a guidance document, FDA must 

provide for public comment upon 

publication and take such comment into 

consideration. (21 U.S.C. 371(h)(1)(C)(i); 

10.115(g)(3)). For Level 2 guidance 

documents (i.e., guidance documents 

that set forth existing practices or minor 

changes in policy), the FD&C Act and 

FDA’s GGP regulation require that FDA 

provide for public comment upon 

implementation. (21 U.S.C. 371(h)(1)(D); 

10.115(g)(4)). 

As part of FDA’s Transparency 

Initiative, in 2011, FDA publicly 

released a comprehensive report 

entitled ‘‘Food and Drug Administration 

Report on Good Guidance Practices: 

Improving Efficiency and 

Transparency’’ (2011 GGP Report, 

available at https://www.fda.gov/aboutfda/transparency/transparencyinitiative). The 2011 GGP Report 

identified ‘‘best practices’’ and made 

recommendations to streamline the 

development of guidance documents, 

reduce the time between issuing draft 

and final guidance documents, and 

improve access to guidance documents 

on FDA’s website. Since 2011, FDA has 

continued to make significant strides to 

modernize and improve our best 

practices for the efficient prioritization, 

development, review, clearance, and 

issuance of our guidance documents. 

The Coronavirus Disease 2019 

(COVID–19) Public Health Emergency 

(PHE) pushed us to consider innovative 

approaches to streamline guidance 

issuance and regulatory submissions to 

reach a broad audience in an expedited 

manner. The facts and circumstances 

surrounding COVID–19 and the COVID– 

19 PHE enabled FDA to rapidly 

disseminate Agency recommendations 

and policies related to COVID–19 to 

industry and other interested parties, 

FDA staff, and the public, including 

patients and consumers. The Agency 

used Paperwork Reduction Act waivers, 

issuance of Level 1 guidance documents 

without prior public participation, and 

expedited external review of guidance 

documents, which translated into 

significant time savings. These tools 

were critical to the significant work 

FDA accomplished during the COVID– 

19 pandemic. Now that the PHE 

determined under section 319 of the 

Public Health Service Act is over, FDA 

is considering the lessons learned from 

that experience and reassessing our 

current best practices for guidance to 

look for additional areas for 

improvement consistent with our 

statutory and regulatory framework. 

In accordance with section 2505(a) of 

the Consolidated Appropriations Act of 

2023 (Pub. L. 117–328), FDA’s ‘‘Draft 

Report and Plan on Best Practices for 

Guidance’’ identifies our current best 

practices for the efficient prioritization, 

development, issuance, and use of 

guidance documents. As a part of this 

draft report and plan, FDA is also 

considering opportunities to streamline 

processes for regulatory submissions 

through the revision and issuance of 

guidance documents and to implement 

innovative guidance development 

processes and practices. Pursuant to 

section 2505(c) of the Consolidated 

Appropriations Act, in this Federal 

Register notice announcing the 

availability of this document, FDA is 

seeking public comment on this ‘‘Draft 

Report and Plan on Best Practices for 

Guidance.’’ 

II. Request for Comments 

FDA is soliciting comments on its 

‘‘Draft Report and Plan on Best Practices 

for Guidance’’ from a broad range of 

commenters, including regulated 

industry; researchers; academic 

organizations; pharmaceutical, 

biotechnology, and medical device 

developers; clinical research 

organizations; clinical laboratories; 

healthcare providers; food 

manufacturers; and consumer and 

patient groups. We are particularly 

interested in feedback on the following 

areas: 

1. FDA regularly considers its 

processes for the development, 

clearance, and issuance of guidance 

documents, with a goal of streamlining 

these processes and making the best use 

of Agency resources. The draft report 

summarizes FDA’s current best 

practices for the initiation, 

prioritization, development, review, 

clearance, and issuance of guidance 

documents that FDA has implemented 

in response to the 2011 report and other 

continual improvement efforts not 

described in the 2011 report. The draft 

report also proposes additional 

initiatives that FDA could consider to 

further improve its processes for the 

issuance of guidance documents. FDA 

solicits input on whether there are 

additional or revised practices, 

consistent with our statutory and 

regulatory framework, for the Agency to 

consider. 

2. Level 1 guidance documents are 

guidance documents that include initial 

interpretations of a statute or regulation, 

changes in interpretation or policy that 

are of more than a minor nature, 

complex scientific issues, or highly 

controversial issues. Level 2 guidance 

documents describe existing practices or 

minor changes in interpretation or 

policy. Pursuant to FDA’s statutory and 

regulatory requirements, while the 

public may comment on a guidance 

document at any time, public 

participation is directly solicited prior 

to the implementation of Level 1 

guidance documents unless we 

determine that such prior public 

participation is not feasible or 

appropriate. In the preamble to the final 

GGP rule, we noted that we anticipated 

that this exception would generally be 

applicable when there are public health 

reasons for the immediate 

implementation of the guidance 

document; there is a statutory 

requirement, executive order, or court 

order that requires immediate 

implementation; or the guidance 

document presents a less burdensome 

policy that is consistent with public 

health.1 Issuing more guidance 

documents either as Level 1 guidance 

documents for immediate 

implementation, as FDA did during the 

COVID–19 PHE, or as Level 2 guidance 

documents would allow FDA to allocate 

its limited resources more efficiently, 

which would help FDA keep pace with 

rapid scientific developments and better 

serve the public health. In addition, 


ddrumheller on DSK120RN23PROD with NOTICES1
382 Federal Register / Vol. 89, No. 2 / Wednesday, January 3, 2024 / Notices 

FDA’s GGP regulation provides that the 

public may comment on any guidance at 

any time, including Level 1 guidance 

documents for immediate 

implementation and Level 2 guidance 

documents, and FDA may delay 

implementation of any guidance 

document. 

a. In light of the above, we seek input 

on whether there are any additional 

circumstances, categories of guidance 

documents, or topics for guidance for 

which it may be appropriate and 

consistent with the FD&C Act and 

FDA’s GGP regulation for FDA to 

consider issuance as a Level 1 guidance 

document for immediate 

implementation without prior public 

comment. 

b. We also seek comment on whether 

there are additional categories or types 

of guidance documents that FDA should 

consider issuing as Level 2 guidance 

documents to streamline the guidance 

process and allow the Agency to better 

leverage its resources for the timely 

development of more guidance 

documents. 

3. FDA requests comment on any 

novel guidance document formats that 

would be of particular utility, such as 

use of templates to accompany a 

guidance document, Q&A formats, 

flowcharts, etc., that are used in FDA 

guidance documents or that were used 

in guidance documents issued in 

response to the COVID–19 PHE. 

4. FDA makes robust use of guidance 

documents to assist industry in making 

regulatory submissions. As described in 

the report, examples of such guidances 

include device-specific guidance 

documents, disease or indication 

specific guidance documents that 

include recommendations on 

developing drugs intended to treat a 

specific disease or for a specific 

indication to support submissions of 

New Drug Applications (NDAs) or 

Supplemental NDAs, product specific 

guidances for generic drug development 

to support submission of Abbreviated 

New Drug Applications (ANDAs), Data 

Technical Conformance Guides to 

accompany guidance documents, and 

guidance documents that provide 

assistance with registration and listing 

requirements. FDA requests comment 

on the utility of guidances in 

streamlining regulatory submissions and 

whether there are additional categories 

or types of guidance that would be 

helpful to streamline processes for 

regulatory submissions to the Agency. 

5. Currently, FDA’s GGP regulation 

(§ 10.115) provides that interested 

persons can suggest areas for guidance 

document development and that such 

suggestions should address why a 

guidance document is necessary. 

(§ 10.115(f)(2)). In addition, proposed 

guidance documents can be submitted 

to a specified docket for FDA 

consideration. (§ 10.115(f)(3)). FDA 

requests comments on whether the 

currently available mechanisms for 

submitting suggested areas for guidance 

development and proposed guidance 

documents are useful and sufficient or 

whether additional mechanisms, for 

example, a Center-specific or Officespecific mailbox for such suggestions 

would ease the process for such 

submissions. 

6. FDA Centers publish guidance 

agendas on their web pages to give 

interested parties and the public notice 

of the areas in which FDA is 

considering upcoming guidance. We 

request comment on the utility of these 

guidance agendas and what, if any, 

modifications to these agendas would be 

helpful for the Agency to consider. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft report and plan at 

https://www.fda.gov/about-fda/reports/ 

reports-agency-policies-and-initiatives 

or https://www.regulations.gov. 

Dated: December 22, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–28872 Filed 1–2–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Current List of HHS-Certified 

Laboratories and Instrumented Initial 

Testing Facilities Which Meet Minimum 

Standards To Engage in Urine and Oral 

Fluid Drug Testing for Federal 

Agencies 

AGENCY: Substance Abuse and Mental 

Health Services Administration, HHS. 

ACTION: Notice. 

SUMMARY: The Department of Health and 

Human Services (HHS) notifies Federal 

agencies of the laboratories and 

Instrumented Initial Testing Facilities 

(IITFs) currently certified to meet the 

standards of the Mandatory Guidelines 

for Federal Workplace Drug Testing 

Programs using Urine or Oral Fluid 

(Mandatory Guidelines). 

FOR FURTHER INFORMATION CONTACT: 

Anastasia Flanagan, Division of 

Workplace Programs, SAMHSA/CSAP, 

5600 Fishers Lane, Room 16N06B, 

Rockville, Maryland 20857; 240–276– 

2600 (voice); Anastasia.Flanagan@

samhsa.hhs.gov (email). 

SUPPLEMENTARY INFORMATION: In 

accordance with section 9.19 of the 

Mandatory Guidelines, a notice listing 

all currently HHS-certified laboratories 

and IITFs is published in the Federal 

Register during the first week of each 

month. If any laboratory or IITF 

certification is suspended or revoked, 

the laboratory or IITF will be omitted 

from subsequent lists until such time as 

it is restored to full certification under 

the Mandatory Guidelines. 

If any laboratory or IITF has 

withdrawn from the HHS National 

Laboratory Certification Program (NLCP) 

during the past month, it will be listed 

at the end and will be omitted from the 

monthly listing thereafter. 

This notice is also available on the 

internet at https://www.samhsa.gov/ 

workplace/resources/drug-testing/ 

certified-lab-list. 

The Department of Health and Human 

Services (HHS) notifies Federal agencies 

of the laboratories and Instrumented 

Initial Testing Facilities (IITFs) 

currently certified to meet the standards 

of the Mandatory Guidelines for Federal 

Workplace Drug Testing Programs 

(Mandatory Guidelines) using Urine and 

of the laboratories currently certified to 

meet the standards of the Mandatory 

Guidelines using Oral Fluid. 

The Mandatory Guidelines using 

Urine were first published in the 

Federal Register on April 11, 1988 (53 

FR 11970), and subsequently revised in 

the Federal Register on June 9, 1994 (59 

FR 29908); September 30, 1997 (62 FR 

51118); April 13, 2004 (69 FR 19644); 

November 25, 2008 (73 FR 71858); 

December 10, 2008 (73 FR 75122); April 

30, 2010 (75 FR 22809); and on January 

23, 2017 (82 FR 7920). 

The Mandatory Guidelines using Oral 

Fluid were first published in the 

Federal Register on October 25, 2019 

(84 FR 57554) with an effective date of 

January 1, 2020. 

The Mandatory Guidelines were 

initially developed in accordance with 

Executive Order 12564 and section 503 

of Public Law 100–71 and allowed urine 

drug testing only. The Mandatory 

Guidelines using Urine have since been 

revised, and new Mandatory Guidelines 

allowing for oral fluid drug testing have 

been published. The Mandatory 

Guidelines require strict standards that 

laboratories and IITFs must meet in 

order to conduct drug and specimen 

validity tests on specimens for Federal 

agencies. HHS does not allow IITFs to 

conduct oral fluid testing. 

To become certified, an applicant 

laboratory or IITF must undergo three 


ddrumheller on DSK120RN23PROD with NOTICES1