13736 Federal Register / Vol. 87, No. 47 / Thursday, March 10, 2022 / Notices 

from attempting to identify any persons 

in the data. Contact information on 

HCUP DUAs is retained in the event 

that a violation of the HCUP DUA takes 

place requiring legal remedy. 

Estimated Annual Respondent Burden 

Exhibit 1 shows the estimated 

annualized burden associated with the 

applicants’ time to order any of the 

HCUP databases. An estimated 1,800 

persons will order HCUP data annually. 

Each of these persons will complete 

Online Application Order Form for 

HCUP products (30 minutes). The total 

burden for the Online Application 

Order Form is estimated to be 900 hours 

annually. Exhibit 2 shows the estimated 

annualized cost burden associated with 

the applicants’ time to order HCUP data. 

The total cost burden is estimated to be 

$39,879 annually. 

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS

Form name Number of 

respondents 

Number of 

responses per 

respondent 

Hours per 

response 

Total burden 

hours 

Total for the HCUP Data Purchase Ordering Form ........................................ 1,800 1 30/60 900 

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN

Number of 

respondents 

Total burden 

hours 

Average 

hourly wage 

rate * 

Total cost 

burden 

Total ................................................................................................................. 1,800 900 $44.31 $39,879 

*Based upon the mean of the average wages for Life Scientists, All Other (19–1099), National Compensation Survey: Occupational Employment Statistics, May 2020 National Occupational Employment and Wage Estimates United States, U.S. Department of Labor, Bureau of Labor 

Statistics. https://www.bls.gov/oes/current/oes_nat.htm#19-0000. 

Request for Comments 

In accordance with the Paperwork 

Reduction Act, 44 U.S.C. 3501–3520, 

comments on AHRQ’s information 

collection are requested with regard to 

any of the following: (a) Whether the 

proposed collection of information is 

necessary for the proper performance of 

AHRQ’s health care research and health 

care information dissemination 

functions, including whether the 

information will have practical utility; 

(b) the accuracy of AHRQ’s estimate of 

burden (including hours and costs) of 

the proposed collection(s) of 

information; (c) ways to enhance the 

quality, utility and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information upon the 

respondents, including the use of 

automated collection techniques or 

other forms of information technology. 

Comments submitted in response to 

this notice will be summarized and 

included in the Agency’s subsequent 

request for OMB approval of the 

proposed information collection. All 

comments will become a matter of 

public record. 

Dated: March 7, 2022. 

Marquita Cullom, 

Associate Director. 

[FR Doc. 2022–05122 Filed 3–9–22; 8:45 am] 

BILLING CODE 4160–90–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–1285] 

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 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 

virtually on April 21, 2022, from 12 

p.m. to 3:30 p.m. Eastern Time and 

April 22, 2022, from 9 a.m. to 1 p.m. 

Eastern Time. 

ADDRESSES: Please note that due to the 

impact of this COVID–19 pandemic, all 

meeting participants will be joining this 

advisory committee meeting via an 

online teleconferencing platform. 

Answers to commonly asked questions 

about FDA advisory committee meetings 

may be accessed at: https://

www.fda.gov/AdvisoryCommittees/ 

AboutAdvisoryCommittees/ucm408555.

htm. 

FDA is establishing a docket for 

public comment on this meeting. The 

docket number is FDA–2021–N–1285. 

The docket will close on April 20, 2022. 

Submit either electronic or written 

comments on this public meeting by 

April 20, 2022. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before April 20, 

2022. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of April 20, 2022. Comments 

received by mail/hand delivery/courier 

(for written/paper submissions) will be 

considered timely if they are 

postmarked or the delivery service 

acceptance receipt is on or before that 

date. 

Comments received on or before April 

7, 2022, 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. 


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Federal Register / Vol. 87, No. 47 / Thursday, March 10, 2022 / Notices 13737 

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– 

2021–N–1285 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 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 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: SheChia Chen, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 31, Rm. 2417, Silver Spring, 

MD 20993–0002, 240–402–5343, Fax: 

301–847–8533, 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 coming to the meeting. 

SUPPLEMENTARY INFORMATION: Agenda: 

The meeting presentations will be 

heard, viewed, captioned, and recorded 

through an online teleconferencing 

platform. On April 21, 2022, the 

committee will discuss the appropriate 

approach for phosphatidylinositol-3- 

kinase inhibitors currently under 

development in patients with 

hematologic malignancies and whether 

randomized data should be required to 

support a demonstration of substantial 

evidence of effectiveness and that the 

drug is safe for its intended use in the 

proposed population. 

On April 22, 2022, the committee will 

discuss supplemental new drug 

application 213176/S–002, for UKONIQ 

(umbralisib) tablets, and biologics 

license application 761207, for 

ublituximab injection, both submitted 

by TG Therapeutics, Inc. The proposed 

indication (use) for these two products 

is in combination for the treatment of 

adult patients with chronic lymphocytic 

leukemia or small lymphocytic 

lymphoma. In addition, the committee 

will also discuss the existing umbralisib 

indications in patients with relapsed or 

refractory follicular lymphoma and 

marginal zone lymphoma approved 

under 21 CFR 314.500 (subpart H, 

accelerated approval regulations). 

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 meeting room 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 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, 

orally or in writing, on issues pending 

before the committee. All electronic and 

written submissions submitted to the 

Docket (see ADDRESSES) on or before 

April 7, 2022, will be provided to the 

committee. Oral presentations from the 

public will be scheduled between 

approximately 2 p.m. to 2:30 p.m. 

Eastern Time on April 21, 2022, and 

between approximately 11:40 a.m. to 

12:10 p.m. Eastern Time on April 22, 

2022. 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 March 30, 2022. 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 


khammond on DSKJM1Z7X2PROD with NOTICES
13738 Federal Register / Vol. 87, No. 47 / Thursday, March 10, 2022 / Notices 

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 March 31, 2022. 

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 She-Chia Chen 

(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/Advisory

Committees/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. app. 2). 

Dated: February 28, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–05022 Filed 3–9–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–D–3462] 

Verification Systems Under the Drug 

Supply Chain Security Act for Certain 

Prescription Drugs; Draft Guidance 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 a revised 

draft guidance entitled ‘‘Verification 

Systems Under the Drug Supply Chain 

Security Act for Certain Prescription 

Drugs.’’ This revised draft guidance 

addresses the verification systems that 

manufacturers, repackagers, wholesale 

distributors, and dispensers must have 

in place to comply with the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act), as amended by the Drug Supply 

Chain Security Act (DSCSA). 

Specifically, this revised draft guidance 

covers the statutory verification system 

requirements that include the 

quarantine and investigation of a 

product determined to be suspect and 

the quarantine and disposition of a 

product determined to be illegitimate. 

The revised draft guidance also 

addresses the statutory requirement for 

notification to the Agency of a product 

that has been cleared by a manufacturer, 

repackager, wholesale distributor, or 

dispenser (also referred to as ‘‘trading 

partners’’) after a suspect product 

investigation because it is determined 

that the product is not an illegitimate 

product. Finally, the revised draft 

guidance addresses the statutory 

requirement for responding to requests 

for verification and processing saleable 

returns. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on March 10, 2022. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances 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– 

2018–D–3462 for ‘‘Verification Systems 

Under the Drug Supply Chain Security 

Act for Certain Prescription Drugs; Draft 

Guidance for Industry; Availability.’’ 

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. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 


khammond on DSKJM1Z7X2PROD with NOTICES