57114 Federal Register / Vol. 88, No. 161 / Tuesday, August 22, 2023 / Notices 

Extremely 

satisfied 

Moderately 

satisfied 

Neither 

satisfied nor 

dissatisfied 

Moderately 

dissatisfied 

Extremely 

dissatisfied 

Not 

applicable 

12. That the agency kept offerors informed about any delays in the solicitation process (considering both the initial release and any subsequent delays), if applicable? .................................................................. Æ Æ Æ Æ Æ Æ

13. That the solicitation included clear submission instructions that sufficiently guided offerors or respondents in preparing offers or responses to requests for information? ..................................................... Æ Æ Æ Æ Æ Æ

14. That the solicitation included clear submission instructions that sufficiently guided offerors or respondents in preparing offers or responses to requests for information? ..................................................... Æ Æ Æ Æ Æ Æ

15. That the Government chose an appropriate contract type based on

the requirement and associated risks? .................................................. Æ Æ Æ Æ Æ Æ

16. That the Government chose an appropriate source selection methodology? ................................................................................................. Æ Æ Æ Æ Æ Æ

17. That the agency answered questions regarding the solicitation in

such a way that it helped you to prepare the offer? .............................. Æ Æ Æ Æ Æ Æ

18. With the opportunity to propose unique and innovative solutions

(e.g., the solicitation and evaluation criteria promoted innovation)? ..... Æ Æ Æ Æ Æ Æ

19. With the amount of time the agency gave to submit an offer? ........... Æ Æ Æ Æ Æ Æ

20. That the solicitation’s evaluation methodology allowed for the best

selection among competing offers? ....................................................... Æ Æ Æ Æ Æ Æ

21. With the quality of the agency’s debriefing (e.g., it allowed you to

understand how to improve on similar efforts in the future)? ................ Æ Æ Æ Æ Æ Æ

Overall Satisfaction 

22. How satisfied were you with your overall experience on this acquisition? ........................................................................................................ Æ Æ Æ Æ Æ Æ

Strongly 

agree 

Agree Neutral Disagree Strongly

disagree 

Not 

applicable 

23. This transaction increased my confidence in the acquisition process Æ Æ Æ Æ Æ Æ

24. If given the opportunity, what would you change about the process to improve your experience? [Open Text Field]

The purpose of the Acquisition 360 

Survey is to standardize the gathering of 

feedback regarding preaward and 

debriefing actions so that agencies can 

continually consider and improve their 

performance in early vendor 

engagement efforts and internal 

acquisition practices. 

C. Common Form

This information collection is a

common form. The General Services 

Administration is the sponsor agency of 

this common form. All executive 

agencies covered by the FAR will use 

this common form. Each executive 

agency will report their agency burden 

separately, and the reported information 

will be available at Reginfo.gov. 

D. Annual Burden

General Services Administration

Respondents: 2,689. 

Total Annual Responses: 2,689. 

Total Burden Hours: 448. 

E. Public Comment

A 60-day notice was published as a

part of the notice of the proposed 

rulemaking for FAR case 2017–014 in 

the Federal Register at 85 FR 57177, on 

August 15, 2020. A respondent provided 

comments on a variety of issues on the 

proposed rule; one of the comments 

expressed support for this collection of 

information. 

Comment: Regarding whether the 

collection of information will have 

practical utility, the commenter stated 

that if better communication aids in the 

proper performance of FAR functions, 

both the information and the initiative 

to promote voluntary feedback has 

merit. The commenter finds this 

collection to be a worthy time 

investment to facilitate effective 

communication that could prevent 

delays or errors due to 

miscommunication. 

Response: Noted. 

Obtaining Copies: Requesters may 

obtain a copy of the information 

collection documents from the GSA 

Regulatory Secretariat Division, by 

calling 202–501–4755 or emailing 

GSARegSec@gsa.gov. Please cite OMB 

Control No. 9000–0204, Acquisition 360 

Voluntary Survey. 

Janet Fry, 

Director, Federal Acquisition Policy Division, 

Office of Governmentwide Acquisition Policy, 

Office of Acquisition Policy, Office of 

Governmentwide Policy. 

[FR Doc. 2023–18005 Filed 8–21–23; 8:45 am] 

BILLING CODE 6820–EP–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–3268] 

Oncologic Drugs Advisory Committee; 

Notice of Meeting; Establishment of a 

Public Docket; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; establishment of a 

public docket; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) announces a 

forthcoming public advisory committee 

meeting of the Oncologic Drugs 

Advisory Committee (the Committee). 

The general function of the Committee 

is to provide advice and 

recommendations to FDA on regulatory 

issues. The meeting will be open to the 

public. FDA is establishing a docket for 

public comment on this document. 

DATES: The meeting will be held on 

October 5, 2023, from 9:30 a.m. to 3 

p.m. Eastern Time.

ADDRESSES: All meeting participants

will be heard, viewed, captioned, and

recorded for this advisory committee

meeting via an online teleconferencing

and/or video conferencing platform.

Answers to commonly asked 

questions about FDA advisory 

committee meetings may be accessed at: 

https://www.fda.gov/ 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 88, No. 161 / Tuesday, August 22, 2023 / Notices 57115 

AdvisoryCommittees/AboutAdvisory

Committees/ucm408555.htm. 

FDA is establishing a docket for 

public comment on this meeting. The 

docket number is FDA–2023–N–3268. 

The docket will close on October 4, 

2023. 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 October 4, 2023. Comments 

received by mail/hand delivery/courier 

(for written/paper submissions) will be 

considered timely if they are received 

on or before that date. 

Comments received on or before 

September 21, 2023, will be provided to 

the Committee. Comments received after 

that date will be taken into 

consideration by FDA. In the event that 

the meeting is cancelled, FDA will 

continue to evaluate any relevant 

applications or information, and 

consider any comments submitted to the 

docket, as appropriate. 

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–3268 for ‘‘Oncologic Drugs 

Advisory Committee; Notice of Meeting; 

Establishment of a Public Docket; 

Request for Comments.’’ 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.’’ FDA 

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 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 the 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: 

Joyce Frimpong, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 31, Rm. 2417, 

Silver Spring, MD 20993–0002, 301– 

796–7973, email: ODAC@fda.hhs.gov, or 

FDA Advisory Committee Information 

Line, 1–800–741–8138 (301–443–0572 

in the Washington, DC area). A notice in 

the Federal Register about last-minute 

modifications that impact a previously 

announced advisory committee meeting 

cannot always be published quickly 

enough to provide timely notice. 

Therefore, you should always check 

FDA’s website at https://www.fda.gov/ 

AdvisoryCommittees/default.htm and 

scroll down to the appropriate advisory 

committee meeting link, or call the 

advisory committee information line to 

learn about possible modifications 

before the meeting. 

SUPPLEMENTARY INFORMATION: 

Agenda: The meeting presentations 

will be heard, viewed, captioned, and 

recorded through an online 

teleconferencing and/or video 

conferencing platform. The Committee 

will discuss supplemental new drug 

application (sNDA) 214665/S–005, for 

LUMAKRAS (sotorasib) tablets, 

submitted by Amgen Inc., for the 

proposed treatment of adult patients 

with KRAS G12C mutated locally 

advanced or metastatic non-small cell 

lung cancer, as determined by an FDA 

approved test, who have received at 

least one prior systemic therapy. This 

supplement proposes to convert the 

NDA to full approval based on the 

confirmatory study, CodeBreaK 200. 

The Committee will consider the results 

of the CodeBreaK 200 study and discuss 

the benefit-risk profile of LUMAKRAS. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its website prior to the 

meeting, the background material will 

be made publicly available on FDA’s 

website at the time of the advisory 

committee meeting. Background 

material and the link to the online 

teleconference and/or video conference 

meeting will be available at https://

www.fda.gov/AdvisoryCommittees/ 

Calendar/default.htm. Scroll down to 

the appropriate advisory committee 

meeting link. The meeting will include 

slide presentations with audio and 

video components to allow the 

presentation of materials in a manner 

that most closely resembles an in-person 

advisory committee meeting. 

Procedure: Interested persons may 

present data, information, or views, 


lotter on DSK11XQN23PROD with NOTICES1
57116 Federal Register / Vol. 88, No. 161 / Tuesday, August 22, 2023 / Notices 

orally or in writing, on issues pending 

before the Committee. All electronic and 

written submissions to the Docket (see 

ADDRESSES) on or before September 21, 

2023, will be provided to the 

Committee. Oral presentations from the 

public will be scheduled between 

approximately 1:15 p.m. and 2:15 p.m. 

Eastern Time. Those individuals 

interested in making formal oral 

presentations should notify the contact 

person and submit a brief statement of 

the general nature of the evidence or 

arguments they wish to present, the 

names and addresses of proposed 

participants, and an indication of the 

approximate time requested to make 

their presentation on or before 

September 13, 2023. Time allotted for 

each presentation may be limited. If the 

number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by September 14, 2023. 

For press inquiries, please contact the 

Office of Media Affairs at fdaoma@

fda.hhs.gov or 301–796–4540. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with disabilities. 

If you require accommodations due to a 

disability, please contact Joyce 

Frimpong (see FOR FURTHER INFORMATION

CONTACT) at least 7 days in advance of 

the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our website at 

https://www.fda.gov/ 

AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. 1001 et seq.). This meeting notice 

also serves as notice that, pursuant to 21 

CFR 10.19, the requirements in 21 CFR 

14.22(b), (f), and (g) relating to the 

location of advisory committee meetings 

are hereby waived to allow for this 

meeting to take place using an online 

meeting platform. This waiver is in the 

interest of allowing greater transparency 

and opportunities for public 

participation, in addition to 

convenience for advisory committee 

members, speakers, and guest speakers. 

No participant will be prejudiced by 

this waiver, and that the ends of justice 

will be served by allowing for this 

modification to FDA’s advisory 

committee meeting procedures. 

Dated: August 17, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–18024 Filed 8–21–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–D–0369] 

Product-Specific Guidances; Draft and 

Revised Draft Guidances for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of 

additional draft and revised draft 

product-specific guidances. The 

guidances provide product-specific 

recommendations on, among other 

things, the design of bioequivalence 

(BE) studies to support abbreviated new 

drug applications (ANDAs). In the 

Federal Register of June 11, 2010, FDA 

announced the availability of a guidance 

for industry entitled ‘‘Bioequivalence 

Recommendations for Specific 

Products’’ that explained the process 

that would be used to make productspecific guidances available to the 

public on FDA’s website. The guidances 

identified in this notice were developed 

using the process described in that 

guidance. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by October 23, 2023 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance at any time 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– 

2007–D–0369 for ‘‘Product-Specific 

Guidances; Draft and Revised Draft 

Guidances for Industry.’’ 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 


lotter on DSK11XQN23PROD with NOTICES1