49334 Federal Register / Vol. 86, No. 168 / Thursday, September 2, 2021 / Notices 

This matching program complies with 

these requirements. 

Naomi Goldstein, 

Deputy Assistant Secretary for Planning, 

Research, and Evaluation, ACF. 

Participating Agencies 

Department of Defense, Defense 

Manpower Data Center (DoD/DMDC) is 

the source agency, and each State Public 

Assistance Agency (SPAA) is a nonFederal agency. The Department of 

Health and Human Services, 

Administration for Children and 

Families, Office of Planning, Research 

and Evaluation (HHS/ACF/OPRE) 

facilitates the matching program and is 

not a source or recipient of data used in 

the matching program. 

Authority for Conducting the Matching 

Program 

Sections 402, 1137, and 1903(r) of the 

Social Security Act (42 U.S.C. 602, 

1320b–7, and 1396b(r)). 

Purpose(s) 

This matching program identifies 

individuals receiving both Federal 

compensation (pay or pension benefits) 

and public assistance benefits under 

Federal benefit programs administered 

by the states and verifies public 

assistance clients’ declarations of 

income circumstances. 

Each participating State Public 

Assistance Agency (SPAA) will provide 

the Department of Defense, Defense 

Manpower Data Center (DMDC) with 

finder files containing identifying and 

other data about public assistance 

applicants or recipients (clients), which 

DMDC will match against DoD military 

and civilian pay files, military retired 

pay files, and survivor pay files (Office 

of Personnel Management (OPM) 

civilian retired and survivor pay files 

will not be used). DMDC will return 

matched data to the SPAA, which the 

SPAA will use to verify clients’ 

continued eligibility to receive public 

assistance benefits under HHS’ 

Medicaid and Temporary Assistance for 

Needy Families (TANF) programs and 

the Department of Agriculture’s 

Supplemental Nutrition Assistance 

Program (SNAP) and, if ineligible, to 

take such action as may be authorized 

by law and regulation to ensure fair and 

equitable treatment in the delivery of 

benefits attributable to funds provided 

by the Federal Government. HHS will 

support each SPAA’s efforts to 

participate in the matching program by 

assisting with finalizing the terms of the 

agreement and coordinating signatures 

on the agreement. 

Categories of Individuals 

The categories of individuals whose 

information is involved in the matching 

program are: 

• Individuals who apply for or 

receive public assistance benefits under 

Federal programs administered by the 

states (i.e., under Medicaid, TANF, and 

SNAP); and 

• Individuals who receive 

compensation from the DoD (i.e., 

military, civilian, survivor, or retirement 

pay or pension benefits). 

Categories of Records 

The categories of records involved in 

the matching program are public 

assistance client identifying information 

and Federal pay and pension data. 

A SPAA will provide the following 

data elements to DMDC about each 

public assistance client: 

• Client social security number 

(SSN), client last name, first name, 

client date of birth, address, gender, 

marital status, information regarding the 

specific public assistance benefit being 

received, file date, state name, state 

optional data, client location code, and 

case number. 

DMDC will provide the SPAA with 

match results containing the following 

data elements about any public 

assistance client who is receiving 

compensation from DoD: 

• SSN; state data; record type; file 

date; date of birth; last name; first name; 

middle name; suffix name; sex; gross 

pay; unit identification (ID) code (UIC); 

agency; pay plan; pay grade; pay step; 

basic salary; state residence; Federal 

taxable wages; Federal tax withheld; 

state taxable wages; state tax withheld; 

employee status code; payroll office 

number; personnel office ID; pay basic 

code; pay period end date 

(YYYYMMDD); disbursing date 

(YYYYMMDD); pay status; category 

code; total base pay all drills; marital 

status code; dependents quantity; off 

duty military code; welfare to work hire 

code; city; state; zip; address lines 1, 2, 

3, 4, 5 and 6; mailing address effective; 

claim number; retired pay entitlement 

effective; comments 1, 2, 3 and 4; and 

member SSN. 

System(s) of Records 

The DoD data used in this matching 

program will be disclosed from the 

following system of records, as 

authorized by routine use 16 published 

March 11, 2019: DMDC 01, titled 

‘‘Defense Manpower Data Center Data 

Base,’’ last published in full at 84 FR 

6383 (Feb. 27, 2019), and modified at 84 

FR 8698 (Mar. 11, 2019) and 84 FR 

15605 (Apr. 16, 2019). 

[FR Doc. 2021–19067 Filed 8–31–21; 11:15 am] 

BILLING CODE 4184–79–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0874] 

Proposal To Refuse To Approve a New 

Drug Application for ITCA 650 

(Exenatide in DUROS Device); 

Opportunity for a Hearing 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Director of the Center for 

Drug Evaluation and Research (Center 

Director) at the Food and Drug 

Administration (FDA or Agency) is 

proposing to refuse to approve a new 

drug application (NDA) submitted by 

Intarcia Therapeutics, Inc. (Intarcia), for 

ITCA 650 (exenatide in DUROS device) 

in its present form. This notice 

summarizes the grounds for the Center 

Director’s proposal and offers Intarcia 

an opportunity to request a hearing on 

the matter. 

DATES: Submit either electronic or 

written requests for a hearing by 

October 4, 2021; submit data, 

information, and analyses in support of 

the hearing and any other comments by 

November 1, 2021. 

ADDRESSES: You may submit hearing 

requests, documents in support of the 

hearing, and any other comments as 

follows. Please note that late, untimely 

filed requests and documents will not 

be considered. Electronic requests for a 

hearing must be submitted on or before 

October 4, 2021; electronic documents 

in support of the hearing and any other 

comments must be submitted on or 

before November 1, 2021. The https://

www.regulations.gov electronic filing 

system will accept hearing requests 

until 11:59 p.m. Eastern Time at the end 

of October 4, 2021, and will accept 

documents in support of the hearing 

and any other comments until 11:59 

p.m. Eastern Time at the end of 

November 1, 2021. Documents 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 these 

dates. 

Electronic Submissions 

Submit electronic comments in the 

following way: 


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Federal Register / Vol. 86, No. 168 / Thursday, September 2, 2021 / Notices 49335 

• 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– 

2021–N–0874 for ‘‘Proposal To Refuse 

To Approve a New Drug Application for 

ITCA 650 (Exenatide in DUROS Device); 

Opportunity for a Hearing.’’ 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: 

Kevin Fain, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 22, Rm. 6419, Silver Spring, 

MD 20993, 301–796–5842, Kevin.Fain@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Proposal To Refuse To Approve NDA 

209053 

Intarcia submitted NDA 209053 for 

ITCA 650 (exenatide in DUROS device), 

a drug-device combination product 

intended to deliver the active ingredient 

exenatide, a GLP–1 receptor agonist 

(RA), on November 21, 2016, under 

section 505(b)(1) of the Federal Food, 

Drug, and Cosmetic Act (FD&C Act) (21 

U.S.C. 355(b)(1)). Intarcia proposed that 

ITCA 650 be indicated as an adjunct to 

diet and exercise to improve glycemic 

control in adults with type 2 diabetes 

mellitus (T2DM). 

On September 21, 2017, the former 

Division of Metabolism and 

Endocrinology Products (DMEP), Office 

of Drug Evaluation II (now the Division 

of Diabetes, Lipid Disorders, and 

Obesity, within the Office of Cardiology, 

Hematology, Endocrinology and 

Nephrology (OCHEN)) in the Office of 

New Drugs (OND) in FDA’s Center for 

Drug Evaluation and Research (CDER), 

issued a complete response letter to 

Intarcia under § 314.110(a) (21 CFR 

314.110(a)) stating that NDA 209053 

could not be approved in its present 

form, describing the specific 

deficiencies and, where possible, 

recommending ways that Intarcia might 

remedy these deficiencies. On 

September 9, 2019, Intarcia resubmitted 

the NDA under section 505(b)(1) of the 

FD&C Act. On March 9, 2020, the former 

DMEP issued a second complete 

response letter stating that NDA 209053 

could not be approved in its present 

form, describing the specific 

deficiencies and, where possible, 

recommending ways that Intarcia might 

remedy these deficiencies. These 

deficiencies, which are summarized 

below, include the following: 

1. The clinical trial data demonstrated 

that ITCA 650 causes acute kidney 

injury (AKI). 

a. A signal of AKI was evident in the 

pivotal phase 3 trials of the ITCA 650 

clinical development program. A 

standardized Medical Dictionary for 

Regulatory Activities query for acute 

renal failure identified reports of AKI 

serious adverse events in 14 subjects 

(0.6 percent) who received ITCA 650 

versus 4 subjects (0.2 percent) who 

received placebo. 

b. The magnitude of the AKI risk was 

greater for ITCA 650 than for the 

marketed exenatide products or for 

other members of the GLP–1 RA class. 

Although other drugs in the GLP–1 RA 

class have a risk of AKI, this 

information is based on spontaneous 

postmarketing adverse event reports. 

The risk of AKI was not detected in the 

clinical trials that supported the 

approval of these drugs. In contrast, the 

risk of AKI was clearly identified in the 

ITCA 650 clinical trial data. This AKI 

risk for ITCA 650, compared to other 

members of the GLP–1 RA class, is 

particularly concerning because it was 

identified from these adequate and wellcontrolled clinical trials, which 

constitute stronger evidence for 

assessing a drug’s safety than 

spontaneous postmarketing adverse 

event reports. 

c. AKI events experienced by 

participants who received ITCA 650 

sometimes resulted in prolonged 

hospitalization; complications observed 

in association with AKI events included 

dialysis and death. 

d. A majority of the serious AKI 

events in participants randomized to 

ITCA 650 appeared to be associated 

with vomiting, diarrhea, and 

dehydration, which are known adverse 


lotter on DSK11XQN23PROD with NOTICES1
49336 Federal Register / Vol. 86, No. 168 / Thursday, September 2, 2021 / Notices 

1Available at https://www.fda.gov/media/ 

126910/download. FDA updates guidances 

periodically. For the most recent version of a 

guidance, check the FDA guidance web page at 

https://www.fda.gov/regulatory-information/searchfda-guidance-documents. 

reactions associated with exenatide 

therapy, supporting a causal 

relationship between ITCA 650 and 

AKI. 

e. Intarcia’s proposed risk mitigation 

measures were inadequate and 

sufficient risk mitigation approaches 

could not be identified for the AKI risk 

identified in the clinical trial data, 

particularly because serious AKI events 

occurred in participants who received 

ITCA 650 who did not have known risk 

factors (moderate to severe renal 

impairment or use of concomitant 

medications that increase the risk of 

AKI) and serious AKI events were 

observed with use of both the nominal 

initial/reduced dose ITCA 650, 20 

micrograms (mcg)/day, and the nominal 

maintenance dose ITCA 650, 60 mcg/ 

day. 

2. The cardiovascular risk assessment 

failed to provide sufficient assurance 

that ITCA 650 is not associated with 

excess cardiovascular (CV) risk. Rather, 

the clinical trial data suggested that 

ITCA 650 may be associated with an 

increased risk for major adverse 

cardiovascular events (MACE), defined 

as myocardial infarction, nonfatal 

stroke, and cardiovascular death. 

a. A prespecified meta-analysis 

incorporated the data from clinical trials 

CLP–103, CLP–105, and CLP–107, and 

included 181 MACE and unstable 

angina (UA) events. An unfavorable 

point estimate of 1.12 was observed 

[hazard ratio (HR) for MACE + UA; 1.12 

(95 percent confidence interval (CI): 

0.83, 1.51)]. 

b. Furthermore, estimates of CV risk 

from the meta-analysis were notably 

higher and nominally statistically 

significant in the subgroup of 

participants 65 years of age or older [HR 

for MACE + UA; 1.67 (95 percent CI: 

1.02, 2.71)]. Subgroup analyses also 

suggested an interaction between CV 

risk and baseline renal function, where 

the HR estimates trended higher with 

worse renal function. 

c. The CV risk analyses from trial 

CLP–107 augmented the concern that 

the drug is associated with a higher risk 

for MACE. CLP–107 was a randomized, 

double-blind, placebo-controlled 

cardiovascular outcomes trial (CVOT) 

conducted in a patient population at 

high risk of MACE. CLP–107 

contributed 174 of the 181 total MACE 

+ UA events observed in the CV risk 

meta-analysis. In CLP–107, the 

assessment of product-related CV risk 

yielded an HR for MACE of 1.24 (95 

percent CI: 0.90, 1.70). 

d. This CV risk resulting from ITCA 

650 use is particularly concerning when 

compared to the beneficial effect of 

other drugs in this class on CV 

outcomes. In contrast to the unfavorable 

CVOT results for ITCA 650, some other 

GLP–1 RA products carry indications 

for MACE risk reduction in patients 

with T2DM based on favorable results of 

CVOTs. The MACE HR observed in a 

CVOT conducted for another 

formulation of exenatide was 0.91 (95 

percent CI: 0.83, 1.0). The lower bound 

of the CLP–107 confidence interval 

(0.90) nearly excludes the point estimate 

for MACE risk observed with this other 

product (0.91), suggesting a true 

difference in MACE risk between the 

products. 

3. The data provided to validate the 

limits of the in vitro dose delivery 

specifications did not support the safe 

and effective use of the device 

constituent of ITCA 650. 

a. The device design validation data 

did not support the proposed daily, 

weekly, and biweekly in vitro drugrelease specifications as appropriate for 

the intended use. 

b. The in vitro device performance 

data demonstrated inconsistent day-today drug delivery and did not support 

that weekly and biweekly in vitro drugrelease testing is adequate to ensure 

controlled in vivo drug release by the 

device constituent of ITCA 650. 

4. The data provided, inclusive of 

delivery performance data and failure 

analyses, did not demonstrate adequate 

device reliability associated with in 

vitro dose delivery to support safety and 

effectiveness for the intended use. 

a. Variability in the daily in vitro 

drug-release data did not support the 

use of weekly and biweekly averages to 

calculate device failure rates. 

b. The failure rate data was 

inadequate to support the safety and 

effectiveness of the device constituent of 

ITCA 650. 

c. The sponsor provided inadequate 

mitigation strategies to reduce device 

failures. 

5. The information provided, 

including the following, was inadequate 

in support of sterility assurance for 

ITCA 650: 

a. The container-closure integrity test 

data provided to support integrity of a 

container-closure system used for sterile 

intermediate storage of sterile 

components of ITCA 650. 

b. Information regarding the productcontact filling equipment used for 

commercial manufacturing of ITCA 650. 

c. Information provided to support the 

routine depyrogenation process for 

components of the primary containerclosure system for ITCA 650. 

d. The method suitability data 

provided to support the proposed 

routine endotoxins test method with 

ITCA 650. 

6. An FDA inspection of the Intarcia 

manufacturing facility identified 

deficiencies with the manufacturing 

practices for ITCA 650 that were not 

adequately addressed. 

a. Controls were inadequate to ensure 

empty devices would not be included in 

the final release of ITCA 650. 

b. Qualification of the filling line with 

an original or new manifold was not 

performed. 

c. The results and reports of the 

process simulation test, used to 

demonstrate the effectiveness of 

preventing microbiological 

contamination of ITCA 650, were not 

provided. 

The complete response letters issued 

on September 21, 2017, and March 9, 

2020, both stated that to address the 

clinical deficiencies, Intarcia should 

address all the specific device and 

product quality-related deficiencies and 

provide additional clinical data that 

adequately address the clinical risks and 

establish that ITCA 650 is safe and 

effective for the intended use. The 

complete response letters stated that 

Intarcia is required either to resubmit 

the application, fully addressing all 

deficiencies listed in the letter, or take 

other actions available under § 314.110 

(i.e., withdraw the application or 

request an opportunity for a hearing). 

Applicable regulations, including 21 

CFR 10.75, also provide a mechanism 

for applicants to obtain formal review of 

one or more decisions reflected in a 

complete response letter (see FDA’s 

guidance for industry and review staff 

‘‘Formal Dispute Resolution: Sponsor 

Appeals Above the Division Level’’ 

(November 2017)).1

Intarcia submitted a formal dispute 

resolution request (FDRR) on June 5, 

2020, concerning the complete response 

letter issued on March 9, 2020, by the 

former DMEP. Ellis Unger, Director of 

OND’s OCHEN, denied the FDRR by 

correspondence dated July 30, 2020, 

based on his determination that the 

drug’s unexpected numeric imbalance 

in cases of serious AKI, the MACE 

observed in the CVOT, and devicerelated deficiencies regarding exenatide 

release rates over the life of the product 

outweighed the benefit in reductions in 

Hemoglobin A1c. Intarcia submitted 

another FDRR on August 14, 2020, for 

review of the OCHEN denial. Robert 

Temple, Senior Advisor to OND, denied 

the second FDRR on behalf of OND by 

correspondence dated October 30, 2020, 


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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 


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