37158 Federal Register / Vol. 86, No. 132 / Wednesday, July 14, 2021 / Notices 

This information may also be obtained 

on an expedited basis, upon request, by 

contacting the appropriate Federal 

Reserve Bank and from the Board’s 

Freedom of Information Office at 

https://www.federalreserve.gov/foia/ 

request.htm. Interested persons may 

express their views in writing on the 

standards enumerated in the BHC Act 

(12 U.S.C. 1842(c)). 

Comments regarding each of these 

applications must be received at the 

Reserve Bank indicated or the offices of 

the Board of Governors, Ann E. 

Misback, Secretary of the Board, 20th 

Street and Constitution Avenue NW, 

Washington, DC 20551–0001, not later 

than August 13, 2021. 

A. Federal Reserve Bank of Boston 

(Prabal Chakrabarti, Senior Vice 

President) 600 Atlantic Avenue, Boston, 

Massachusetts 02210–2204. Comments 

can also be sent electronically to 

BOS.SRC.Applications.Comments@

bos.frb.org: 

1. Independent Bank Corp., 

(‘‘Independent’’) through its subsidiary, 

Bradford Merger Sub Inc., both of 

Rockland, Massachusetts; to merge with 

Meridian Bancorp, Inc., Peabody, 

Massachusetts (‘‘Meridian’’), with 

Meridian as the survivor, and thereby 

indirectly acquire East Boston Savings 

Bank, Boston, Massachusetts. 

Immediately after, Meridian to merge 

with Independent, with Independent as 

the survivor, and East Boston Savings 

Bank to merge with and into Rockland 

Trust, Rockland, Massachusetts, a 

wholly owned subsidiary bank of 

Independent, with Rockland Trust as 

the surviving bank. 

Board of Governors of the Federal Reserve 

System, July 9, 2021. 

Michele Taylor Fennell, 

Deputy Associate Secretary of the Board. 

[FR Doc. 2021–14997 Filed 7–13–21; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10341] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, HHS. 

ACTION: Notice; partial withdrawal. 

SUMMARY: On Friday, July 9, 2021, the 

Centers for Medicare & Medicaid 

Services (CMS) published a notice 

entitled, ‘‘Agency Information 

Collection Activities: Submission for 

OMB Review; Comment Request.’’ That 

notice invited public comments on three 

separate information collection requests 

specific to document identifiers: CMS– 

10215, CMS–10249, and CMS–10341. 

Through the publication of this 

document, we are withdrawing the 

portion of the notice requesting public 

comment on the information collection 

request titled ‘‘Section 1115 

Demonstration Projects Regulations at 

42 CFR 431.408, 431.412, 431.420, 

431.424, and 431.428.’’ Form number 

CMS–10341 (OMB control number 

0938–1162). The withdrawn 

information collection request will be 

replaced by another 30-day notice in 

July or August of this year. 

DATES: For CMS–10215 and CMS– 

10249, the original comment period for 

the notice that published on July 9, 

2021, remains in effect and ends August 

9, 2021. 

SUPPLEMENTARY INFORMATION: In FR 

document, 2021–14671, published on 

July 9, 2021 (86 FR 36281), we are 

withdrawing item 3 ‘‘Section 1115 

Demonstration Projects Regulations at 

42 CFR 431.408, 431.412, 431.420, 

431.424, and 431.428’’ which posted on 

page 36282. 

Dated: July 9, 2021. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2021–15005 Filed 7–13–21; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–P–0191] 

Determination That STROMECTOL 

(Ivermectin) Tablets, 6 Milligrams, 

Were Not Withdrawn From Sale for 

Reasons of Safety or Effectiveness 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) has 

determined that STROMECTOL 

(ivermectin) tablets, 6 milligrams (mg), 

were not withdrawn from sale for 

reasons of safety or effectiveness. This 

determination will allow FDA to 

approve abbreviated new drug 

applications (ANDAs) for 

STROMECTOL (ivermectin) tablets, 6 

mg, if all other legal and regulatory 

requirements are met. 

FOR FURTHER INFORMATION CONTACT: 

Christopher Koepke, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993–0002, 301–796–3600, 

Christopher.Koepke@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 1984, 

Congress enacted the Drug Price 

Competition and Patent Term 

Restoration Act of 1984 (Pub. L. 98–417) 

(the 1984 amendments), which 

authorized the approval of duplicate 

versions of drug products under an 

ANDA procedure. ANDA applicants 

must, with certain exceptions, show that 

the drug for which they are seeking 

approval contains the same active 

ingredient in the same strength and 

dosage form as the ‘‘listed drug,’’ which 

is a version of the drug that was 

previously approved. ANDA applicants 

do not have to repeat the extensive 

clinical testing otherwise necessary to 

gain approval of a new drug application 

(NDA). 

The 1984 amendments include what 

is now section 505(j)(7) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

355(j)(7)), which requires FDA to 

publish a list of all approved drugs. 

FDA publishes this list as part of the 

‘‘Approved Drug Products With 

Therapeutic Equivalence Evaluations,’’ 

which is known generally as the 

‘‘Orange Book.’’ Under FDA regulations, 

drugs are removed from the list if the 

Agency withdraws or suspends 

approval of the drug’s NDA or ANDA 

for reasons of safety or effectiveness or 

if FDA determines that the listed drug 

was withdrawn from sale for reasons of 

safety or effectiveness (21 CFR 314.162). 

A person may petition the Agency to 

determine, or the Agency may 

determine on its own initiative, whether 

a listed drug was withdrawn from sale 

for reasons of safety or effectiveness. 

This determination may be made at any 

time after the drug has been withdrawn 

from sale, but must be made prior to 

approving an ANDA that refers to the 

listed drug (§ 314.161 (21 CFR 314.161)). 

FDA may not approve an ANDA that 

does not refer to a listed drug. 

STROMECTOL (ivermectin) tablets, 6 

mg, are the subject of NDA 050742, held 

by Merck Sharp and Dohme Corp., and 

initially approved on November 22, 

1996. STROMECTOL is indicated for 

strongyloidiasis of the intestinal tract 

and onchocerciasis. 

In a letter dated September 14, 2007, 

Merck and Co., Inc. notified FDA that 

STROMECTOL (ivermectin) tablets, 6 

mg, were being discontinued, and FDA 


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Federal Register / Vol. 86, No. 132 / Wednesday, July 14, 2021 / Notices 37159 

moved the drug product to the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book. 

Foley and Lardner, LLP submitted a 

citizen petition dated February 16, 2021 

(Docket No. FDA–2021–P–0191), under 

21 CFR 10.30, requesting that the 

Agency determine whether 

STROMECTOL (ivermectin) tablets, 6 

mg, were withdrawn from sale for 

reasons of safety or effectiveness. 

After considering the citizen petition 

and reviewing Agency records and 

based on the information we have at this 

time, FDA has determined under 

§ 314.161 that STROMECTOL 

(ivermectin) tablets, 6 mg, were not 

withdrawn for reasons of safety or 

effectiveness. The petitioner has 

identified no data or other information 

suggesting that STROMECTOL 

(ivermectin) tablets, 6 mg, were 

withdrawn for reasons of safety or 

effectiveness. We have carefully 

reviewed our files for records 

concerning the withdrawal of 

STROMECTOL (ivermectin) tablets, 6 

mg, from sale. We have also 

independently evaluated relevant 

literature and data for possible 

postmarketing adverse events. We have 

reviewed the available evidence and 

determined that this drug product was 

not withdrawn from sale for reasons of 

safety or effectiveness. 

Accordingly, the Agency will 

continue to list STROMECTOL 

(ivermectin) tablets, 6 mg, in the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book. The 

‘‘Discontinued Drug Product List’’ 

delineates, among other items, drug 

products that have been discontinued 

from marketing for reasons other than 

safety or effectiveness. ANDAs that refer 

to STROMECTOL (ivermectin) tablets, 6 

mg, may be approved by the Agency as 

long as they meet all other legal and 

regulatory requirements for the approval 

of ANDAs. If FDA determines that 

labeling for this drug product should be 

revised to meet current standards, the 

Agency will advise ANDA applicants to 

submit such labeling. 

Dated: July 7, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–14935 Filed 7–13–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2019–D–3361] 

Eligibility Criteria for Expanded 

Conditional Approval of New Animal 

Drugs; Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

Health and Human Services (HHS). 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of final 

guidance for industry (GFI) #261 

entitled ‘‘Eligibility Criteria for 

Expanded Conditional Approval of New 

Animal Drugs.’’ This guidance is 

intended for sponsors and potential 

sponsors who may be interested in 

pursuing conditional approval of new 

animal drugs for certain major uses in 

major species. Eligibility for conditional 

approval has been expanded beyond 

minor uses in major species and use in 

minor species (MUMS) to include 

certain major uses in major species. The 

Center for Veterinary Medicine (CVM or 

we) refers to the process for 

conditionally approving new animal 

drugs that are not intended for MUMS 

indications as ‘‘expanded conditional 

approval.’’ The purpose of expanded 

conditional approval is to incentivize 

development of new animal drugs for 

serious or life-threatening conditions or 

unmet animal or human health needs 

under circumstances where a 

demonstration of effectiveness would 

require a complex or particularly 

difficult study or studies. This guidance 

defines certain terms, clarifies the 

eligibility criteria for expanded 

conditional approval, and describes the 

criteria CVM intends to consider when 

determining expanded conditional 

approval eligibility. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on July 14, 2021. 

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– 

2019–D–3361 for ‘‘Eligibility Criteria for 

Expanded Conditional Approval of New 

Animal Drugs.’’ 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 


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