Federal Register / Vol. 87, No. 100 / Tuesday, May 24, 2022 / Proposed Rules 31439 

Conclusion 

The FAA has determined that Notice 

Nos. 15–10 and 19–02 have been 

superseded by the Aircraft Certification, 

Safety, and Accountability Act. 

Therefore, the FAA withdraws Notice 

No. 15–10, published at 80 FR 59674 on 

October 2, 2015, and Notice No. 19–02, 

published at 84 FR 15533 on April 16, 

2019, as directed. 

Issued under authority provided by 49 

U.S.C. 106(f), 44701(a), and 44703 in 

Washington, DC. 

Robert C. Carty, 

Deputy Executive Director, Flight Standards 

Service. 

[FR Doc. 2022–10054 Filed 5–23–22; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 10, 12, 16, and 205 

[Docket No. FDA–2020–N–1663] 

RIN 0910–AH11 

National Standards for the Licensure 

of Wholesale Drug Distributors and 

Third-Party Logistics Providers; 

Extension of Comment Period 

AGENCY: Food and Drug Administration, 

Health and Human Services (HHS). 

ACTION: Proposed rule; extension of 

comment period. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

extending the comment period for the 

proposed rule on national standards for 

licensure for wholesale drug distributors 

and third-party logistics providers that 

appeared in the Federal Register of 

February 4, 2022. The Agency is taking 

this action in response to a request for 

an extension to allow interested persons 

additional time to submit comments. 

DATES: FDA is extending the comment 

period on the proposed rule published 

February 4, 2022 (87 FR 6708). Submit 

either electronic or written comments 

by September 6, 2022. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before September 6, 

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

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of September 6, 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. 

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– 

2020–N–1663 for ‘‘National Standards 

for the Licensure of Wholesale Drug 

Distributors and Third-Party Logistics 

Providers.’’ 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: 

Aaron Weisbuch, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 4261, 

Silver Spring, MD 20993, 301–796– 

3130. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of February 4, 2022 (87 

FR 6708), FDA published a proposed 

rule proposing to establish national 

standards for licensure for wholesale 

drug distributors and third-party 

logistics providers. The proposed rule 

provided a 120-day period for 

submission of public comments. 

The Agency has received a request for 

a 90-day extension of the comment 

period for the proposed rule. The 

request conveyed concern that the 

current 120-day comment period, which 

ends on June 6, 2022, does not allow 

sufficient time to develop a meaningful 

or thoughtful response to the proposed 

rule. 


jspears on DSK121TN23PROD with PROPOSALS1
31440 Federal Register / Vol. 87, No. 100 / Tuesday, May 24, 2022 / Proposed Rules 

FDA has considered the request and 

is extending the comment period for the 

proposed rule for 90 days, until 

September 6, 2022. The Agency believes 

that a 90-day extension allows adequate 

time for interested persons to submit 

comments. 

Dated: May 17, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–11116 Filed 5–23–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 630 and 640 

[Docket No. FDA–2022–D–0588] 

Compliance Policy Regarding Blood 

and Blood Component Donation 

Suitability, Donor Eligibility and 

Source Plasma Quarantine Hold 

Requirements; Draft Guidance for 

Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability, draft 

compliance policy. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing the availability of a draft 

document entitled ‘‘Compliance Policy 

Regarding Blood and Blood Component 

Donation Suitability, Donor Eligibility 

and Source Plasma Quarantine Hold 

Requirements; Draft Guidance for 

Industry.’’ The draft guidance document 

addresses certain requirements that 

apply to blood establishments that 

collect blood and blood components, 

including Source Plasma. Specifically, 

the draft guidance explains the 

conditions under which FDA does not 

intend to take regulatory action for a 

blood establishment’s failure to comply 

with certain requirements in the 

biologics regulations regarding donation 

suitability, donor eligibility, and 

quarantine hold for Source Plasma. FDA 

expects that the compliance policy 

described in the draft guidance will 

increase the availability of blood and 

blood components, including Source 

Plasma, while maintaining the health of 

blood donors and the safety of blood 

and blood components. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by July 25, 2022 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

Submit electronic or written comments 

on the proposed collection of 

information in the draft guidance by 

July 25, 2022. 

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–0588 for ‘‘Compliance Policy 

Regarding Blood and Blood Component 

Donation Suitability, Donor Eligibility 

and Source Plasma Quarantine Hold 

Requirements; Draft Guidance 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 

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 Office 

of Communication, Outreach and 

Development, Center for Biologics 

Evaluation and Research (CBER), Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 3128, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist the office in processing your 

requests. The draft guidance may also be 

obtained by mail by calling CBER at 1– 

800–835–4709 or 240–402–8010. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance document. 

FOR FURTHER INFORMATION CONTACT: 

With regard to the draft guidance: 

Phillip Kurs, Center for Biologics 


jspears on DSK121TN23PROD with PROPOSALS1