35648 Federal Register / Vol. 83, No. 145 / Friday, July 27, 2018 / Notices 

Jeffery M. Zirger, 

Acting Chief, Information Collection Review 

Office, Office of Scientific Integrity, Office 

of the Associate Director for Science, Office 

of the Director, Centers for Disease Control 

and Prevention. 

[FR Doc. 2018–16090 Filed 7–26–18; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Advisory Committee to the Director 

(ACD), Centers for Disease Control and 

Prevention (CDC)—Health Disparities 

Subcommittee (HDS) 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Notice of meeting. 

SUMMARY: In accordance with the 

Federal Advisory Committee Act, the 

CDC announces the following meeting 

for the Advisory Committee to the 

Director, Centers for Disease Control 

and Prevention—Health Disparities 

Subcommittee (ACD, CDC–HDS). This 

meeting is open to the public, limited 

only by the 50 audio phone lines. The 

public is also welcome to listen to the 

meeting by teleconference. Please dial 

(866) 918–8397 and enter code 9346283. 

There are 50 lines available. The public 

comment period is from 3:15 p.m.–3:20 

p.m. 

DATES: The meeting will be held on 

October 9, 2018, 1:30 p.m. to 3:30 p.m., 

EDT. 

ADDRESSES: Teleconference phone 

(866) 918–8397 and enter code 9346283. 

FOR FURTHER INFORMATION CONTACT: 

Leandris Liburd, Ph.D., M.P.H., M.A., 

Designated Federal Officer, Health 

Disparities Subcommittee, Advisory 

Committee to the Director, CDC, 1600 

Clifton Road NE, M/S K–77, Atlanta, 

Georgia 30329. Telephone (404) 498– 

6482, Email: ACDirector@cdc.gov. 

SUPPLEMENTARY INFORMATION: 

Purpose: The Subcommittee will 

provide counsel to the CDC Director 

through the ACD on strategic and other 

health disparities and health equity 

issues and provide guidance on 

opportunities for CDC. 

Matters to be Considered: The agenda 

will include discussions on new 

member orientation. This meeting will 

provide information to new members 

regarding their role & duties on this 

subcommittee. Agenda items are subject 

to change as priorities dictate. 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

management activities, for both the 

Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Dia Taylor, 

Acting Chief Operating Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. 2018–16103 Filed 7–26–18; 8:45 am] 

BILLING CODE 4163–19–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–P–1283] 

Determination That Metaxalone 

Tablets, 640 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 metaxalone tablets, 640 

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 

metaxalone tablets, 640 mg, if all other 

legal and regulatory requirements are 

met. 

FOR FURTHER INFORMATION CONTACT: Glen 

Cheng, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave. Bldg. 51, Rm. 6217, Silver Spring, 

MD 20993–0002, 301–796–1494. 

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. 

Metaxalone tablets, 640 mg, are the 

subject of NDA 22–503, held by Primus 

Pharmaceuticals, Inc., and initially 

approved on June 1, 2015. Metaxalone 

tablets, 640 mg, are indicated as an 

adjunct to rest, physical therapy, and 

other measures for the relief of 

discomfort associated with acute, 

painful musculoskeletal conditions. 

In a letter dated September 30, 2015, 

the previous NDA holder CorePharma, 

LLC notified FDA that metaxalone 

tablets, 640 mg, were discontinued, and 

FDA moved the drug product to the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book. 

Sovereign Pharmaceuticals, LLC 

submitted a citizen petition dated 

March 26, 2018 (Docket No. FDA–2018– 

P–1283), under 21 CFR 10.30, 

requesting that the Agency determine 

whether metaxalone tablets, 640 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 metaxalone tablets, 640 

mg, were not withdrawn for reasons of 

safety or effectiveness. The petitioner 

has identified no data or other 

information suggesting that metaxalone 

tablets, 640 mg, were withdrawn for 

reasons of safety or effectiveness. We 

have carefully reviewed our files for 

records concerning the withdrawal of 

metaxalone tablets, 640 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 


amozie on DSK3GDR082PROD with NOTICES1
Federal Register / Vol. 83, No. 145 / Friday, July 27, 2018 / Notices 35649 

not withdrawn from sale for reasons of 

safety or effectiveness. 

Accordingly, the Agency will 

continue to list metaxalone tablets, 640 

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 metaxalone tablets, 640 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 20, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–16031 Filed 7–26–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2016–N–0007] 

Generic Drug User Fee Rates for Fiscal 

Year 2019 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Federal Food, Drug, and 

Cosmetic Act (FD&C Act), as amended 

by the Generic Drug User Fee 

Amendments of 2017 (GDUFA II), 

authorizes the Food and Drug 

Administration (FDA, Agency, or we) to 

assess and collect fees for abbreviated 

new drug applications (ANDAs), drug 

master files (DMFs), generic drug active 

pharmaceutical ingredient (API) 

facilities, finished dosage form (FDF) 

facilities, contract manufacturing 

organization (CMO) facilities, and 

generic drug applicant program user 

fees. In this document, FDA is 

announcing fiscal year (FY) 2019 rates 

for GDUFA II fees. 

FOR FURTHER INFORMATION CONTACT: 

Melissa Hurley, Office of Financial 

Management, Food and Drug 

Administration, 8455 Colesville Rd., 

COLE–14202J, Silver Spring, MD 

20993–0002, 240–402–4585. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Sections 744A and 744B of the FD&C 

Act (21 U.S.C. 379j–41 and 379j–42) 

establish fees associated with human 

generic drug products. Fees are assessed 

on: (1) Certain types of applications for 

human generic drug products; (2) 

certain facilities where APIs and FDFs 

are produced; (3) certain DMFs 

associated with human generic drug 

products; and (4) generic drug 

applicants who have approved ANDAs 

(the program fee) (see section 

744B(a)(2)–(5) of the FD&C Act). 

GDUFA II stipulates that user fees 

should total $493,600,000 annually 

adjusted each year for inflation. For FY 

2019, the generic drug fee rates are: 

ANDA ($178,799), DMF ($55,013), 

domestic API facility ($44,226), foreign 

API facility ($59,226), domestic FDF 

facility ($211,305), foreign FDF facility 

($226,305), domestic CMO facility 

($70,435), foreign CMO facility 

($85,435), large size operation generic 

drug applicant program ($1,862,167), 

medium size operation generic drug 

applicant program ($744,867), and small 

business generic drug applicant program 

($186,217). These fees are effective on 

October 1, 2018, and will remain in 

effect through September 30, 2019. 

II. Fee Revenue Amount for FY 2019 

The base revenue amount for FY 2019 

is $493,600,000, as set in the statute (see 

section 744B(b)(1) of the FD&C Act). 

GDUFA II directs FDA to use the yearly 

revenue amount as a starting point to set 

the fee rates for each fee type. For more 

information about GDUFA II, please 

refer to the FDA website (https://

www.fda.gov/gdufa). The ANDA, DMF, 

API facility, FDF facility, CMO facility, 

and generic drug applicant program fee 

(GDUFA program fee) calculations for 

FY 2019 are described in this document. 

GDUFA II specifies that the 

$493,600,000 is to be adjusted for 

inflation increases for FY 2019 using 

two separate adjustments—one for 

personnel compensation and benefits 

(PC&B) and one for non-PC&B costs (see 

sections 744B(c)(1)(B) and (C) of the 

FD&C Act). 

The component of the inflation 

adjustment for PC&B costs shall be one 

plus the average annual percent change 

in the cost of all PC&B paid per full-time 

equivalent position (FTE) at FDA for the 

first 3 of the 4 preceding fiscal years, 

multiplied by the proportion of PC&B 

costs to total FDA costs of human 

generic drug activities for the first 3 of 

the preceding 4 fiscal years (see section 

744B(c)(1)(B) of the FD&C Act). 

Table 1 summarizes the actual cost 

and total FTE for the specified fiscal 

years, and provides the percent change 

from the previous fiscal year and the 

average percent change over the first 3 

of the 4 fiscal years preceding FY 2019. 

The 3-year average is 2.4152 percent. 

TABLE 1—FDA PERSONNEL COMPENSATION AND BENEFITS (PC&B) EACH YEAR AND PERCENT CHANGE

Fiscal year 2015 2016 2017 3-Year average 

Total PC&B .............................................................................. $2,232,304,000 $2,414,728,159 $2,581,551,000 ..............................

Total FTE ................................................................................. 15,484 16,381 17,022 ..............................

PC&B per FTE ......................................................................... $144,168 $147,408 $151,660 ..............................

Percent Change from Previous Year ...................................... 2.1136 2.2474 2.8845 2.4152 

The statute specifies that this 2.4152 

percent should be multiplied by the 

proportion of PC&B expended for 

human generic drug activities for the 

first 3 of the preceding 4 fiscal years. 

Table 2 shows the amount of PC&B and 

the total amount obligated for human 

generic drug activities from FY 2015 

through FY 2017. 

TABLE 2—PC&B AS A PERCENT OF FEE REVENUES SPENT ON THE PROCESS OF HUMAN GENERIC DRUG APPLICATIONS

OVER THE LAST 3 YEARS

Fiscal year 2015 2016 2017 3-Year average 

PC&B ....................................................................................... $201,116,305 $242,963,571 $271,748,229 ..............................

Non-PC&B ............................................................................... $251,589,013 $250,987,599 $262,058,852 ..............................

Total Costs ............................................................................... $452,705,318 $493,951,170 $533,807,081 ..............................


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