Federal Register / Vol. 87, No. 72 / Thursday, April 14, 2022 / Notices 22215 

11,339,400 prescriptions) will 

necessitate documenting rationales. 

Averaging this figure equally among 

7,500 compounding pharmacies, 1,134 

(rounded to the nearest whole number) 

rationales will be documented annually, 

for a total of 8,505,000 records. We 

estimate it will take 1 minute (0.017 

hours) to document the rationales 

described in the guidance, for a total of 

144,585 hours, as reported in table 1. 

Under 5 CFR 1320.3(b)(2), the time, 

effort, and financial resources necessary 

to comply with a collection of 

information are excluded from the 

burden estimate if the reporting, 

recordkeeping, or disclosure activities 

needed to comply are usual and 

customary because they would occur in 

the normal course of activities. If the 

compounded drug is compounded for 

use as an antidote for food-producing 

animals or for use as a sedative or 

anesthetic for free-ranging wildlife 

species, section III.C.3 of the guidance 

recommends that the veterinarian 

establishes and documents a 

scientifically based withdrawal time 

that ensures residues of the: (1) Antidote 

and the underlying toxin or (2) sedative 

or anesthetic are not present in the 

animal at the time of slaughter or 

harvest or the veterinarian ensures the 

animal does not enter the food supply. 

We believe that it is usual and 

customary for veterinarians to establish 

and document a scientifically based 

withdrawal time as a matter of 

maintaining an adequate medical record 

in routine practice and, therefore, 

estimate no burden for the time it would 

take for a veterinarian to make this 

record. See 5 CFR 1320.3(b)(2). 

In addition, the guidance makes a 

number of recommendations regarding 

the labeling of animal drugs 

compounded from bulk drug 

substances. In sections III.A.8, III.B.6, 

and III.C.6, the guidance recommends 

basic information that pharmacists and 

veterinarians should include on the 

label of the compounded drug, such as 

the name and strength of the drug and 

the name, address, and contact 

information for the compounding 

pharmacy or compounding veterinarian. 

We believe that it is usual and 

customary for pharmacists and 

veterinarians to include such 

information on the labels of 

compounded animal drugs in the 

normal course of their activities, and 

therefore, estimate no burden for the 

time it would take to prepare such 

labeling. See 5 CFR 1320.3(b)(2). 

Sections III.A.8, III.B.6, and III.C.6 of the 

guidance also recommend compounders 

(pharmacists and veterinarians) include 

several specific statements on the label 

of animal drugs compounded from bulk 

drug substances (e.g., ‘‘This is a 

compounded drug. Not an FDA 

approved or indexed drug.’’). Because 

these recommended labeling statements 

are public disclosure of information 

originally supplied by the Federal 

Government to the recipient for the 

purpose of disclosure to the public (5 

CFR 1320.3(c)(2)), they are exempt from 

OMB review and approval under the 

PRA. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at https://

www.fda.gov/animal-veterinary/ 

guidance-regulations/guidanceindustry, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, or https://

www.regulations.gov. 

Dated: April 11, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–08092 Filed 4–13–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–N–0470] 

Cellular, Tissue and Gene Therapies 

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 Cellular, Tissue and Gene 

Therapies Advisory Committee. The 

general function of the committee is to 

provide advice and recommendations to 

FDA on scientific 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 June 

9, 2022, from 10 a.m. to 6 p.m. and June 

10, 2022, from 10 a.m. to 4 p.m. Eastern 

Time. 

ADDRESSES: Please note that due to the 

impact of the 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. 

The online web conference meeting 

will be available at the following link on 

the day of the meeting: Day 1 June 9 

link: https://youtu.be/RvtTK3KNl5g and 

Day 2 June 10 link: https://youtu.be/ 

Eo2BXnGienc. 

FDA is establishing a docket for 

public comment on this meeting. The 

docket number is FDA–2022–N–0470. 

The docket will close on June 8, 2022. 

Submit either electronic or written 

comments on this public meeting on or 

before June 8, 2022. Please note that 

late, untimely filed comments will not 

be considered. Electronic comments 

must be submitted on or before June 8, 

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

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of June 8, 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 June 

2, 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. 

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 


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22216 Federal Register / Vol. 87, No. 72 / Thursday, April 14, 2022 / Notices 

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– 

2022–N–0470 for ‘‘Cellular, Tissue and 

Gene Therapies 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: 

Christina Vert or Tonica Burke, Center 

for Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

1244, Silver Spring, MD 20993–0002, 

ctgtac@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 the 

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. The committee will discuss 

two biologics license applications 

(BLAs) from bluebird bio, Inc.: (1) BLA 

125755 for elivaldogene autotemcel 

(autologous CD34+ stem cells 

genetically modified with a lentiviral 

vector to contain an adenosine 

triphosphate-binding cassette, subfamily D, member 1 gene that encodes 

a functional adrenoleukodystrophy 

protein); the applicant has requested an 

indication for the treatment of patients 

younger than 18 years of age with early 

cerebral adrenoleukodystrophy who do 

not have an available and willing 

human leukocyte antigen-matched 

sibling hematopoietic stem cell donor 

and (2) BLA 125717 for betibeglogene 

autotemcel (autologous CD34+ stem 

cells genetically modified with a 

lentiviral vector to contain a gene 

encoding functional beta-globin); the 

applicant has requested an indication 

for the treatment of patients with bthalassemia who require regular red 

blood cell transfusions. 

The morning session of June 9, 2022, 

will include presentations of the 

effectiveness and product-specific safety 

results from the clinical trials in BLA 

125755. The afternoon session will 

include presentations of safety concerns 

relevant to both products, followed by 

committee discussion of BLA 125755. 

On June 10, 2022, the morning session 

will include presentations of the 

effectiveness and product-specific safety 

results from the clinical trials in BLA 

125717. The afternoon session will 

include committee discussion of BLA 

125717. 

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 

June 2, 2022, will be provided to the 

committee. Oral presentations from the 

public will be scheduled between 

approximately 1 p.m. and 2 p.m. Eastern 

Time on June 9, 2022, and between 

approximately 1 p.m. and 2 p.m. Eastern 

Time on June 10, 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 May 25, 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 

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 May 26, 2022. 

For press inquiries, please contact the 

Office of Media Affairs at fdaoma@

fda.hhs.gov or 301–796–4540. 


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Federal Register / Vol. 87, No. 72 / Thursday, April 14, 2022 / Notices 22217 

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 Christina Vert 

at ctgtac@fda.hhs.gov (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/AboutAdvisory

Committees/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: April 11, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–08022 Filed 4–13–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–D–0108] 

Considerations for Waiver Requests 

for pH Adjusters in Generic Drug 

Products Intended for Parenteral, 

Ophthalmic, or Otic Use; 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 draft 

guidance for industry entitled 

‘‘Considerations for Waiver Requests for 

pH Adjusters in Generic Drug Products 

Intended for Parenteral, Ophthalmic, or 

Otic Use.’’ This guidance is intended to 

assist abbreviated new drug application 

(ANDA) applicants that reference a drug 

product intended for parenteral, 

ophthalmic, or otic use in seeking 

approval of a drug that is qualitatively 

(Q1) different or quantitatively (Q2) 

different from the reference listed drug 

(RLD) with respect to the pH adjuster(s). 

This draft guidance describes how FDA 

intends to evaluate a request for a 

waiver of Agency requirements for a Q1 

or Q2 difference in pH adjuster, 

including recommendations on the type 

of information to provide in support of 

such a waiver request. This draft 

guidance also includes 

recommendations on the timing and 

process for submitting such waiver 

requests. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by June 13, 2022 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– 

2022–D–0108 for ‘‘Considerations for 

Waiver Requests for pH Adjusters in 

Generic Drug Products Intended for 

Parenteral, Ophthalmic, or Otic Use.’’ 

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)). 

Submit written requests for single 

copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002. Send one self-addressed adhesive 

label to assist that office in processing 

your requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Melissa Mannion, Center for Drug 


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