29586 Federal Register / Vol. 86, No. 104 / Wednesday, June 2, 2021 / Notices 

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was withdrawn from sale for reasons of 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a listed drug was withdrawn from sale 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time after the drug has been withdrawn 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. 

SANDOSTATIN (octreotide acetate) 

injection, EQ 0.2 mg base/mL and EQ 1 

mg base/mL, is the subject of NDA 

19667, held by Novartis 

Pharmaceuticals Corporation. NDA 

19667 was initially approved on 

October 21, 1988, and the EQ 0.2 mg 

base/mL and EQ 1 mg base/mL strengths 

were approved on June 12, 1991. 

SANDOSTATIN is indicated to reduce 

blood levels of growth hormone and 

IGF–I (somatomedin C) in acromegaly 

patients who have had inadequate 

response to or cannot be treated with 

surgical resection, pituitary irradiation, 

and bromocriptine mesylate at 

maximally tolerated doses. 

SANDOSTATIN is also indicated for the 

symptomatic treatment of patients with 

metastatic carcinoid tumors where it 

suppresses or inhibits the severe 

diarrhea and flushing episodes 

associated with the disease. 

SANDOSTATIN is also indicated for the 

treatment of profuse watery diarrhea 

associated with vasoactive intestinal 

peptide-secreting tumors. 

In a letter received by the Agency on 

May 11, 2020, Novartis Pharmaceuticals 

Corporation notified FDA that 

SANDOSTATIN (octreotide acetate) 

injection, EQ 0.2 mg base/mL and EQ 1 

mg base/mL, was being discontinued, 

and FDA moved the drug product to the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book. Caplin 

Steriles Limited submitted a citizen 

petition dated February 5, 2021 (Docket 

No. FDA–2021–P–0163), under 21 CFR 

10.30, requesting that the Agency 

determine whether SANDOSTATIN 

(octreotide acetate) injection, EQ 0.2 mg 

base/mL and EQ 1 mg base/mL, was 

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 SANDOSTATIN 

(octreotide acetate) injection, EQ 0.2 mg 

base/mL and EQ 1 mg base/mL, was not 

withdrawn for reasons of safety or 

effectiveness. The petitioner has 

identified no data or other information 

suggesting that SANDOSTATIN 

(octreotide acetate) injection, EQ 0.2 mg 

base/mL and EQ 1 mg base/mL, was 

withdrawn for reasons of safety or 

effectiveness. We have carefully 

reviewed our files for records 

concerning the withdrawal of 

SANDOSTATIN (octreotide acetate) 

injection, EQ 0.2 mg base/mL and EQ 1 

mg base/mL, from sale. We have also 

independently evaluated relevant 

literature and data for possible 

postmarketing adverse events. We have 

found no information that would 

indicate that this drug product was 

withdrawn from sale for reasons of 

safety or effectiveness. 

Accordingly, the Agency will 

continue to list SANDOSTATIN 

(octreotide acetate) injection, EQ 0.2 mg 

base/mL and EQ 1 mg base/mL, 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. FDA will not 

begin procedures to withdraw approval 

of approved ANDAs that refer to this 

drug product. Additional ANDAs for 

this drug product may also 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: May 26, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–11575 Filed 6–1–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission to OMB for 

Review and Approval; Public Comment 

Request; Rural Health Care 

Coordination Program Performance 

Improvement and Measurement 

System Database, OMB No. 0906– 

0024—Reinstate With Changes 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: In compliance with the 

Paperwork Reduction Act of 1995, 

HRSA has submitted an Information 

Collection Request (ICR) to the Office of 

Management and Budget (OMB) for 

review and approval. Comments 

submitted during the first public review 

of this ICR will be provided to OMB. 

OMB will accept further comments from 

the public during the review and 

approval period. 

DATES: Comments on this ICR should be 

received no later than July 2, 2021. 

ADDRESSES: Submit your comments, 

including the ICR Title, to the desk 

officer for HRSA, either by email to 

OIRA_submission@omb.eop.gov or by 

fax to (202) 395–5806. 

FOR FURTHER INFORMATION CONTACT: To 

request a copy of the clearance requests 

submitted to OMB for review, email the 

HRSA Information Collection Clearance 

Officer at paperwork@hrsa.gov or call 

(301) 443–1984. 

SUPPLEMENTARY INFORMATION: When 

submitting comments or requesting 

information, please include the 

information request collection title for 

reference. 

Information Collection Request Title: 

Rural Health Care Coordination Program 

Performance Improvement and 

Measurement System Database, OMB 

No. 0906–0024—Reinstate with 

Changes. 

Abstract: The Rural Health Care 

Coordination (Care Coordination) 

program is authorized under Section 

330A(e) of the Public Health Service 

(PHS) Act (42 U.S.C. 254(e)), as 

amended, to ‘‘improve access and 


jbell on DSKJLSW7X2PROD with NOTICES
Federal Register / Vol. 86, No. 104 / Wednesday, June 2, 2021 / Notices 29587 

quality of care through the application 

of care coordination strategies with the 

focus areas of collaboration, leadership 

and workforce, improved outcomes, and 

sustainability in rural communities.’’ 

This authority permits the Federal 

Office of Rural Health Policy to support 

rural health consortiums/networks 

aiming to achieve the overall goals of 

improving access, delivery, and quality 

of care through the application of care 

coordination strategies in rural 

communities. 

This ICR was discontinued in January 

2020. HRSA is requesting a 

reinstatement with changes as it was 

decided to re-compete this pilot 

program. 

The proposed Rural Health Care 

Coordination Program draft measures 

for information collection reflect 

changes to the Clinical Measures section 

which was previously in section eight 

and now currently in section six. The 

Clinical Measures Section now expands 

previous project focus from three 

chronic diseases (i.e., Type 2 diabetes, 

Congestive Heart Failure, and Chronic 

Obstructive Pulmonary Disease) to an 

inclusive list of clinical measures in 

order to reflect a patient’s overall health 

and well-being as well as the 

organizations’ overall improved 

outcomes for the project. Proposed 

revisions also include measures to 

examine key elements cited for a 

successful rural care coordination 

program: (1) Collaboration, (2) 

leadership and workforce, (3) improved 

outcomes, and (4) sustainability. 

1. Collaboration—Utilizing a 

collaborative approach to coordinate 

and deliver health care services through 

a consortium, in which member 

organizations actively engage in 

integrated, coordinated, patientcentered delivery of health care 

services. 

2. Leadership and Workforce— 

Developing and strengthening a highly 

skilled care coordination workforce to 

respond to vulnerable populations’ 

unmet needs within the rural 

communities. 

3. Improved Outcomes—Expanding 

access and improving care quality and 

delivery, and health outcomes through 

evidence-based model and/or promising 

practices tailored to meet the local 

populations’ needs. 

4. Sustainability—Developing and 

strengthening care coordination 

program’s financial sustainability by 

establishing effective revenue sources 

such as expanded service 

reimbursement, resource sharing, and/or 

contributions from partners at the 

community, county, regional, and state 

levels. 

With the continuing shift in the 

healthcare environment towards 

provision of value-based care and 

utilization of reimbursement strategies 

through Centers for Medicare and 

Medicaid Services quality reporting 

programs, the latest competitive Rural 

Health Care Coordination Program 

cohort also aligned with this shift. An 

increased number of sophisticated 

applicants leveraging increasingly 

intricate reporting methodologies for 

quality, data collection, utilization and 

analysis has resulted in an estimate of 

burden hours more in line with the 

realities of the health care landscape. In 

addition, the total number of responses 

has increased to 10 since the previous 

Notice of Award. This is due to a new 

Rural Health Care Coordination Program 

grant cycle with an increased number of 

awardees therefore an increased number 

of respondents. 

A 60-day notice published in the 

Federal Register on November 30, 2020, 

vol. 85, No. 230; pp. 76585–86. There 

were no public comments. 

Need and Proposed Use of the 

Information: For this program, 

performance measures were drafted to 

provide data to the program and to 

enable HRSA to provide aggregate 

program data required by Congress 

under the Government Performance and 

Results Act of 1993. These measures 

cover the principal topic areas of 

interest to the Office of Rural Health 

Policy, including: (a) Access to care; (b) 

population demographics; (c) staffing; 

(d) consortium/network; (e) 

sustainability; and (f) project specific 

domains. All measures will speak to 

HRSA’s progress toward meeting the 

goals set. 

Likely Respondents: The respondents 

would be recipients of the Rural Health 

Care Coordination Program funding. 

Burden Statement: Burden in this 

context means the time expended by 

persons to generate, maintain, retain, 

disclose or provide the information 

requested. This includes the time 

needed to review instructions; to 

develop, acquire, install, and utilize 

technology and systems for the purpose 

of collecting, validating, and verifying 

information, processing and 

maintaining information, and disclosing 

and providing information; to train 

personnel and to be able to respond to 

a collection of information; to search 

data sources; to complete and review 

the collection of information; and to 

transmit or otherwise disclose the 

information. The total annual burden 

hours estimated for this ICR are 

summarized in the table below. 

TOTAL ESTIMATED ANNUALIZED BURDEN HOURS

Form name Number of 

respondents 

Number of 

responses per 

respondent 

Total 

responses 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

Rural Health Care Coordination Grant Program Measures 10 1 10 3.5 35 

Total .............................................................................. 10 ........................ 10 ........................ 35 


jbell on DSKJLSW7X2PROD with NOTICES
29588 Federal Register / Vol. 86, No. 104 / Wednesday, June 2, 2021 / Notices 

HRSA specifically requests comments 

on: (1) The necessity and utility of the 

proposed information collection for the 

proper performance of the agency’s 

functions, (2) the accuracy of the 

estimated burden, (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected, and (4) the 

use of automated collection techniques 

or other forms of information 

technology to minimize the information 

collection burden. 

Maria G. Button, 

Director, Executive Secretariat. 

[FR Doc. 2021–11542 Filed 6–1–21; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Meeting of the Advisory Committee on 

Infant Mortality 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: In accordance with the 

Federal Advisory Committee Act, this 

notice announces that the Advisory 

Committee on Infant Mortality (ACIM) 

has scheduled a public meeting. 

Information about ACIM and the agenda 

for this meeting can be found on the 

ACIM website at https://www.hrsa.gov/ 

advisory-committees/infant-mortality/ 

index.html. 

DATES: June 22, 2021, 12:00 p.m.–4:00 

p.m. Eastern Time (ET) and June 23, 

2021, 12:00 p.m.–4:00 p.m. ET. 

ADDRESSES: This meeting will be held 

via webinar. The webinar link and login information will be available at 

ACIM’s website before the meeting: 

https://www.hrsa.gov/advisorycommittees/infant-mortality/index.html. 

FOR FURTHER INFORMATION CONTACT: 

Vanessa Lee, MPH, Acting Designated 

Federal Official, Maternal and Child 

Health Bureau, HRSA, 5600 Fishers 

Lane, Rockville, Maryland 20857; 301– 

443–0543; or SACIM@hrsa.gov. 

SUPPLEMENTARY INFORMATION: The ACIM 

is authorized by section 222 of the 

Public Health Service Act (42 U.S.C. 

217a), as amended. The Committee is 

governed by provisions of Public Law 

92–463, as amended, (5 U.S.C. App. 2), 

which sets forth standards for the 

formation and use of Advisory 

Committees. 

The ACIM advises the Secretary of 

HHS on department activities and 

programs directed at reducing infant 

mortality and improving the health 

status of pregnant women and infants. 

The ACIM represents a public-private 

partnership at the highest level to 

provide guidance and focus attention on 

the policies and resources required to 

address the reduction of infant mortality 

and the improvement of the health 

status of pregnant women and infants. 

With a focus on life course, the ACIM 

addresses disparities in maternal health 

to improve maternal health outcomes, 

including preventing and reducing 

maternal mortality and severe maternal 

morbidity. The ACIM provides advice 

on how best to coordinate myriad 

federal, state, local, and private 

programs and efforts that are designed 

to deal with the health and social 

problems impacting infant mortality and 

maternal health, including 

implementation of the Healthy Start 

program and maternal and infant health 

objectives from the National Health 

Promotion and Disease Prevention 

Objectives (i.e., Healthy People 2030). 

The agenda for the June 22–23, 2021, 

meeting is being finalized and may 

include the following topics: Discussion 

of recommendations by ACIM to the 

Secretary; updates from HRSA’s 

Maternal and Child Health Bureau, and 

other federal agencies; the Centers for 

Disease Control and Prevention’s 

Pregnancy Risk Assessment Monitoring 

System survey; and patient-physician 

racial concordance in health care. 

Agenda items are subject to change as 

priorities dictate. Refer to the ACIM 

website for any updated information 

concerning the meeting. 

Members of the public will have the 

opportunity to provide written or oral 

comments. Requests to submit a written 

statement or make oral comments to the 

ACIM should be sent to Vanessa Lee, 

using the email address above at least 3 

business days prior to the meeting. 

Public participants may submit written 

statements in advance of the scheduled 

meeting by emailing SACIM@hrsa.gov. 

Oral comments will be honored in the 

order they are requested and may be 

limited as time allows. 

Individuals who plan to attend and 

need special assistance or another 

reasonable accommodation should 

notify Vanessa Lee at the contact 

information listed above at least 10 

business days prior to the meeting. 

Maria G. Button, 

Director, Executive Secretariat. 

[FR Doc. 2021–11504 Filed 6–1–21; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health. 

National Institute of Neurological 

Disorders and Stroke; Notice of Closed 

Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Neurological Disorders and Stroke Special 

Emphasis Panel; Music and Health. 

Date: June 24, 2021. 

Time: 9:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852 (Virtual 

Meeting). 

Contact Person: W. Ernest Lyons, PhD, 

Scientific Review Administrator, Scientific 

Review Branch, NINDS/NIH/DHHS, 

Neuroscience Center, 6001 Executive Blvd., 

Suite 3208, MSC 9529, Rockville, MD 20852, 

301–496–4056, lyonse@ninds.nih.gov. 

Name of Committee: National Institute of 

Neurological Disorders and Stroke Special 

Emphasis Panel; Small Vessel VCID 

Biomarkers Validation Consortium Sites & 

Coordinating Center Review (U01 & U24). 

Date: June 25, 2021. 

Time: 10:30 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852 (Virtual 

Meeting). 

Contact Person: Mir Ahamed Hossain, 

PhD, Scientific Review Officer, Scientific 

Review Branch, NINDS/NIH/DHHS, 

Neuroscience Center, 6001 Executive Blvd., 

Suite 3208, MSC 9529, Rockville, MD 20852, 

301–496–9223, mirahamed.hossain@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.853, Clinical Research 

Related to Neurological Disorders; 93.854, 

Biological Basis Research in the 

Neurosciences, National Institutes of Health, 

HHS) 


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