Federal Register / Vol. 86, No. 168 / Thursday, September 2, 2021 / Notices 49337 

based on his determination that the 

drug’s clinical risks, device-related 

deficiencies, and product quality and 

manufacturing deficiencies had not 

been satisfactorily resolved, reaffirming 

the reasoning in OCHEN’s denial of the 

prior FDRR. Intarcia submitted a third 

FDRR on November 27, 2020, for review 

of the OND denial and requested an 

advisory committee meeting. Douglas 

Throckmorton, Deputy Director for 

Regulatory Programs, CDER, denied the 

third FDRR and the request for an 

advisory committee meeting on behalf 

of CDER by correspondence dated 

February 12, 2021, based on his 

determination that the drug’s clinical 

risks and device-related deficiencies 

had not been satisfactorily resolved, 

reaffirming the reasoning in OND’s 

denial of the prior FDRR, and 

determined that an advisory committee 

would be premature because of these 

unresolved safety issues. 

On March 16, 2021, Intarcia 

submitted a request for an opportunity 

for a hearing under § 314.110(b)(3) on 

whether there are grounds under section 

505(d) of the FD&C Act for denying 

approval of NDA 209053. 

II. Notice of Opportunity for a Hearing 

For the reasons stated above and as 

explained in further detail in the March 

9, 2020, complete response letter and 

the February 12, 2021, November 27, 

2020, and July 30, 2020, FDRR denials, 

notice is given to Intarcia and all other 

interested persons that the Center 

Director proposes to issue an order 

refusing to approve NDA 209053 on the 

grounds that the application fails to 

meet the criteria for approval under 

section 505(d) of the FD&C Act, 

including the following: (1) Data 

submitted in the application do not 

show that the product would be safe 

under the proposed conditions of use 

(section 505(d)(2) of the FD&C Act) and 

(2) the methods used in, and the 

facilities and controls used for, the 

manufacture, processing, or packing of 

the product are not shown to be 

adequate to preserve its identity, 

strength, quality, and purity (section 

505(d)(3) of the FD&C Act). 

Intarcia may request a hearing before 

the Commissioner of Food and Drugs 

(the Commissioner) on the Center 

Director’s proposal to refuse to approve 

NDA 209053. If Intarcia decides to seek 

a hearing, it must file: (1) A written 

notice of participation and request for a 

hearing (see the DATES section) and (2) 

the studies, data, information, and 

analyses relied upon to justify a hearing 

(see the DATES section), as specified in 

§ 314.200 (21 CFR 314.200). 

As stated in § 314.200(g), a request for 

a hearing may not rest upon mere 

allegations or denials, but must present 

specific facts showing that there is a 

genuine and substantial issue of fact 

that requires a hearing to resolve. We 

note in this regard that because CDER 

proposes to refuse to approve NDA 

209053 based on the multiple 

deficiencies summarized above, any 

hearing request from Intarcia must 

address all of those deficiencies. Failure 

to request a hearing within the time 

provided and in the manner required by 

§ 314.200 constitutes a waiver of the 

opportunity to request a hearing. If a 

hearing request is not properly 

submitted, FDA will issue a notice 

refusing to approve NDA 209053. 

The Commissioner will grant a 

hearing if there exists a genuine and 

substantial issue of fact or if the 

Commissioner concludes that a hearing 

would otherwise be in the public 

interest (§ 314.200(g)(6)). If a hearing is 

granted, it will be conducted according 

to the procedures provided in 21 CFR 

parts 10 through 16 (21 CFR 314.201). 

Paper submissions under this notice 

of opportunity for a hearing should be 

filed in one copy, except for those 

submitted as ‘‘Confidential 

Submissions’’ (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Except for data and information 

prohibited from public disclosure under 

21 U.S.C. 331(j) or 18 U.S.C. 1905, 

submissions may be seen in the Dockets 

Management Staff Office between 9 a.m. 

and 4 p.m., Monday through Friday, and 

on the internet at https://

www.regulations.gov. This notice is 

issued under section 505(c)(1)(B) of the 

FD&C Act and §§ 314.110(b)(3) and 

314.200. 

Dated: August 27, 2021. 

Jacqueline Corrigan-Curay, 

Principal Deputy Center Director, Center for 

Drug Evaluation and Research. 

[FR Doc. 2021–18928 Filed 9–1–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration; 

Delegation of Authority 

Notice is hereby given that I have 

delegated to the Food and Drug 

Administration (FDA) Commissioner of 

Food and Drugs (Commissioner), the 

authority vested in the Secretary to 

issue all regulations of the FDA. This 

includes authority to issue regulations 

pursuant to the Federal Food, Drug, and 

Cosmetic Act (FD&C Act), applicable 

portions of the Public Health Service 

Act (PHS Act), and other authorities 

governing functions of the FDA. This 

authority may be re-delegated by the 

Commissioner. 

On September 15, 2020, the Secretary 

of Health and Human Services (HHS) 

issued a memorandum (‘‘September 15 

Memorandum’’) to the HHS Heads of 

Operating and Staff Divisions that 

reserved to the Secretary ‘‘the authority 

to sign and issue any rule for which 

notice and comment would normally be 

required, irrespective of whether notice 

and comment is waived.’’ The 

September 15 Memorandum further 

stated that it rescinded ‘‘any prior 

delegation of rulemaking authority’’ to 

the Operating Divisions, including FDA. 

This delegation revokes the September 

15 Memorandum as it applies to FDA 

and reinstates any delegations to FDA 

rescinded by the September 15 

Memorandum. 

This delegation shall be exercised in 

accordance with the Department’s 

applicable policies, procedures, and 

guidelines. For internal Department 

management purposes, this delegation is 

subject to certain reservations of 

authority for the Secretary to approve 

FDA regulations. Specifically, the 

Secretary reserves the authority to 

approve regulations of FDA, except 

regulations to which sections 556 and 

557 of Title 5 U.S.C. apply, which (1) 

establish procedural rules applicable to 

a general class of foods, drugs, 

cosmetics, medical devices, tobacco 

products, or other subjects of regulation; 

or (2) present highly significant public 

issues involving the quality, availability, 

marketability, or cost of one or more 

foods, drugs, cosmetics, medical 

devices, tobacco products, or other 

subjects of regulation. The delegation 

does not preclude the Secretary from 

approving a regulation, or being notified 

in advance of an action, to which 

section 556 and 557 of Title 5 U.S.C. 

apply, which meets one of the abovereferenced criteria. This reservation of 

authority is intended only to improve 

the internal management of the 

Department of Health and Human 

Services, and it is not intended to create 

any right or benefit, substantive or 

procedural, enforceable at law by a 

party against the United States, the 

Department of Health and Human 

Services, the FDA, any Agency, officer, 

or employee of the United States, or any 

person. Regulations issued by FDA 

without the approval of the Secretary 

are to be conclusively viewed as falling 

outside the scope of this reservation of 

authority. 

This delegation became effective upon 

the date of signature. In addition, I 

hereby affirm and ratify any actions 


lotter on DSK11XQN23PROD with NOTICES1
49338 Federal Register / Vol. 86, No. 168 / Thursday, September 2, 2021 / Notices 

taken by the Commissioner or the 

Commissioner’s subordinates which 

involved the exercise of the authorities 

delegated herein, or substantially 

similar authorities, prior to the effective 

date of the delegation. 

Dated: August 30, 2021. 

Xavier Becerra, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2021–18985 Filed 9–1–21; 8:45 am] 

BILLING CODE 4164–28–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; 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: Center for Scientific 

Review Special Emphasis Panel; Shared 

Instrumentation: NMR and X-Ray (S10). 

Date: October 6, 2021. 

Time: 10:00 a.m. to 9:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Shan Wang, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, 6701 Rockledge Drive, 

Bethesda, MD 20892, 858–735–0788, 

shan.wang@nih.gov. 

Name of Committee: Integrative, 

Functional and Cognitive Neuroscience 

Integrated Review Group; Behavioral 

Neuroendocrinology, Neuroimmunology, 

Rhythms, and Sleep Study Section. 

Date: October 7–8, 2021. 

Time: 8:00 a.m. to 7:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Michael Selmanoff, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5164, 

MSC 7844, Bethesda, MD 20892, 301–435– 

1119, selmanom@csr.nih.gov. 

Name of Committee: Risk, Prevention and 

Health Behavior Integrated Review Group; 

Psychosocial Development, Risk and 

Prevention Study Section. 

Date: October 7–8, 2021. 

Time: 9:00 a.m. to 8:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Anna L. Riley, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3114, 

MSC 7759, Bethesda, MD 20892, 301–435– 

2889, rileyann@csr.nih.gov. 

Name of Committee: Biological Chemistry 

and Macromolecular Biophysics Integrated 

Review Group; Synthetic and Biological 

Chemistry B Study Section. 

Date: October 7–8, 2021. 

Time: 9:00 a.m. to 8:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Michael Eissenstat, Ph.D., 

Scientific Review Officer, BCMB IRG, Center 

for Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4166, 

MSC 7806, Bethesda, MD 20892, 301–435– 

1722, eissenstatma@csr.nih.gov. 

Name of Committee: Interdisciplinary 

Molecular Sciences and Training Integrated 

Review Group; Enabling Bioanalytical and 

Imaging Technologies Study Section. 

Date: October 7–8, 2021. 

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

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Kenneth Ryan, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3218, 

MSC 7717, Bethesda, MD 20892, 301–435– 

0229, kenneth.ryan@nih.hhs.gov. 

Name of Committee: Biological Chemistry 

and Macromolecular Biophysics Integrated 

Review Group; Macromolecular Structure 

and Function C Study Section. 

Date: October 7–8, 2021. 

Time: 9:00 a.m. to 8:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: William A. Greenberg, 

Ph.D., Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4168, 

MSC 7806, Bethesda, MD 20892, (301) 435– 

1726, greenbergwa@csr.nih.gov. 

Name of Committee: Cardiovascular and 

Respiratory Sciences Integrated Review 

Group; Cardiovascular Differentiation and 

Development Study Section. 

Date: October 7, 2021. 

Time: 9:30 a.m. to 7:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Sara Ahlgren, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, RM 4136, 

Bethesda, MD 20817–7814, 301–435–0904, 

sara.ahlgren@nih.gov. 

Name of Committee: Surgical Sciences, 

Biomedical Imaging and Bioengineering 

Integrated Review Group; Surgery, 

Anesthesiology and Trauma Study Section. 

Date: October 7–8, 2021. 

Time: 9:30 a.m. to 8:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Weihua Luo, MD, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5114, 

MSC 7854, Bethesda, MD 20892, (301) 435– 

1170, luow@csr.nih.gov. 

Name of Committee: Integrative, 

Functional and Cognitive Neuroscience 

Integrated Review Group; Sensory-Motor 

Neuroscience Study Section. 

Date: October 7–8, 2021. 

Time: 10:00 a.m. to 7:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: John Bishop, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5182, 

MSC 7844, Bethesda, MD 20892, (301) 408– 

9664, bishopj@csr.nih.gov. 

Name of Committee: Oncology 1-Basic 

Translational Integrated Review Group; 

Tumor Cell Biology Study Section. 

Date: October 7–8, 2021. 

Time: 10:00 a.m. to 8:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Charles Morrow, MD, 

Ph.D., Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 6202, 

MSC 7804, Bethesda, MD 20892, 301–408– 

9850, morrowcs@csr.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: August 30, 2021. 

Melanie J. Pantoja, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2021–18980 Filed 9–1–21; 8:45 am] 

BILLING CODE 4140–01–P 


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