39100 Federal Register / Vol. 83, No. 153 / Wednesday, August 8, 2018 / Notices 

comment does not include any sensitive 

or confidential information. In 

particular, your comment should not 

include any sensitive personal 

information, such as your or anyone 

else’s Social Security number; date of 

birth; driver’s license number or other 

state identification number, or foreign 

country equivalent; passport number; 

financial account number; or credit or 

debit card number. You are also solely 

responsible for making sure that your 

comment does not include any sensitive 

health information, such as medical 

records or other individually 

identifiable health information. In 

addition, your comment should not 

include any ‘‘trade secret or any 

commercial or financial information 

which . . . is privileged or 

confidential’’—as provided by Section 

6(f) of the FTC Act, 15 U.S.C. 46(f), and 

FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2)— 

including in particular competitively 

sensitive information such as costs, 

sales statistics, inventories, formulas, 

patterns, devices, manufacturing 

processes, or customer names. 

Comments containing material for 

which confidential treatment is 

requested must be filed in paper form, 

must be clearly labeled ‘‘Confidential,’’ 

and must comply with FTC Rule 4.9(c). 

In particular, the written request for 

confidential treatment that accompanies 

the comment must include the factual 

and legal basis for the request, and must 

identify the specific portions of the 

comment to be withheld from the public 

record. See FTC Rule 4.9(c). Your 

comment will be kept confidential only 

if the General Counsel grants your 

request in accordance with the law and 

the public interest. Once your comment 

has been posted on the public FTC 

website—as legally required by FTC 

Rule 4.9(b)—we cannot redact or 

remove your comment from the FTC 

website, unless you submit a 

confidentiality request that meets the 

requirements for such treatment under 

FTC Rule 4.9(c), and the General 

Counsel grants that request. 

The FTC Act and other laws that the 

Commission administers permit the 

collection of public comments to 

consider and use in this proceeding as 

appropriate. The Commission will 

consider all timely and responsive 

public comments that it receives on or 

before October 9, 2018. For information 

on the Commission’s privacy policy, 

including routine uses permitted by the 

Privacy Act, see https://www.ftc.gov/ 

site-information/privacy-policy. 

Heather Hippsley, 

Acting Principal Deputy General Counsel. 

[FR Doc. 2018–16936 Filed 8–7–18; 8:45 am] 

BILLING CODE 6750–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day–18–1072] 

Agency Forms Undergoing Paperwork 

Reduction Act Review 

In accordance with the Paperwork 

Reduction Act of 1995, the Centers for 

Disease Control and Prevention (CDC) 

has submitted the information 

collection request titled Enhanced STD 

surveillance Network (SSuN) to the 

Office of Management and Budget 

(OMB) for review and approval. CDC 

previously published a ‘‘Proposed Data 

Collection Submitted for Public 

Comment and Recommendations’’ 

notice on March, 15, 2018 to obtain 

comments from the public and affected 

agencies. CDC received 37 comments 

related to the previous notice. This 

notice serves to allow an additional 30 

days for public and affected agency 

comments. 

CDC will accept all comments for this 

proposed information collection project. 

The Office of Management and Budget 

is particularly interested in comments 

that: 

(a) Evaluate whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information will have 

practical utility; 

(b) Evaluate the accuracy of the 

agencies estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used; 

(c) Enhance the quality, utility, and 

clarity of the information to be 

collected; 

(d) Minimize the burden of the 

collection of information on those who 

are to respond, including, through the 

use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology, 

e.g., permitting electronic submission of 

responses; and 

(e) Assess information collection 

costs. 

To request additional information on 

the proposed project or to obtain a copy 

of the information collection plan and 

instruments, call (404) 639–7570 or 

send an email to omb@cdc.gov. Direct 

written comments and/or suggestions 

regarding the items contained in this 

notice to the Attention: CDC Desk 

Officer, Office of Management and 

Budget, 725 17th Street NW, 

Washington, DC 20503 or by fax to (202) 

395–5806. Provide written comments 

within 30 days of notice publication. 

Proposed Project 

Enhanced STD surveillance Network 

(SSuN)—Reinstatement with Change— 

Division of STD Prevention (DSTDP), 

National Center for HIV/AIDS, Viral 

Hepatitis, STD, and TB prevention 

(NCHHSTP), Centers for Disease Control 

and Prevention (CDC). 

Background and Brief Description 

The Enhanced STD surveillance 

network project was created to provide 

enhanced behavioral, demographic, and 

clinical information on gonorrhea cases 

reported to state and local health 

departments, to provide information on 

patients presenting for care in STD 

clinical settings, and to provide an 

infrastructure for identifying emerging 

sequelae of STDs. 

Enhanced SSuN continues to be a 

collaboration between different 

branches of the CDC Division of STD 

Prevention and selected state/local 

public health departments and their 

associated STD specialty care clinics in 

the US. Data from enhanced SSuN data 

is used to (1) provide a dataset of 

supplemental information on gonorrhea 

case reports; (2) provide geographic 

information on case reports of STDs of 

interest for investigating social 

determinants of STDs, (3) monitor STD 

screening, incidence, prevalence, 

epidemiologic and health care access 

trends in populations of interest, (4) 

monitor STD treatment and prevention 

service practices, and (5) monitor 

selected adverse health outcomes of 

STDs, including neuro/ocular syphilis, 

This project will continue to utilize 

two distinct surveillance strategies to 

collect information. The first strategy 

employs facility-based sentinel 

surveillance, which will abstract routine 

standardized data from existing 

electronic medical records for all patient 

visits to participating STD clinics 

during the project period. For the 

facility-based component of enhanced 

SSuN, participating sites have 

developed common protocols 

stipulating data elements to be 

collected, including patient 

demographics, clinical, risk and sexual 

behaviors. The specified data elements 

are abstracted by clinic staff from 


sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 83, No. 153 / Wednesday, August 8, 2018 / Notices 39101 

existing electronic medical records for 

all patient visits to participating STD 

clinics. Some of the participating 

facilities are satellite clinics of large 

network providers where clinical data 

systems are centralized. Hence, there are 

10 unique clinic data managers that will 

be abstracting the facility data. Each of 

the clinic data managers will spend 

three hours to extract and transmit data 

to local/state health departments. 

Individual patient records are deidentified (all patient-specific identifiers 

are removed) by clinic staff before being 

transmitted to health departments, who 

recode the data into standardized 

formats before being transmitted to CDC 

through secure file transport 

mechanisms. Each enhanced SSuN site 

will spend 16 hours to recode and 

transmit the data to CDC every other 

month. At CDC, data will be aggregated 

across all participating sites in a 

common data structure and formatted 

for analysis. 

Under this revision, the second 

strategy, population-based STD 

surveillance is being expanded to 

include not only a random sample of 

reported gonorrhea cases but also 

include patients diagnosed with early 

syphilis that report neurologic/ocular 

manifestations. For the gonorrhea 

population component, a probability 

sample of gonorrhea cases (up to 10% 

of total gonorrhea morbidity for 

participating jurisdictions) will be 

contacted by health department staff for 

a standardized interview either by 

phone or in-person. Enhanced 

gonorrhea investigations will also 

include verification of treatment and an 

internal health department record 

review (performed on either all cases or 

on the sampled cases). The focus of the 

new population activity focuses on 

obtaining additional clinical 

information on early syphilis cases who 

report neurologic/ocular symptoms. The 

subset of patients reporting these 

symptoms are asked to participate in an 

interview to obtain additional clinical 

information for a more complete 

assessment of neurologic/ocular 

involvement as well as obtain additional 

clinical information from the diagnosing 

or reporting provider. Lastly, early 

syphilis cases reporting neurologic and/ 

or ocular symptoms are recontacted at 

approximately three months following 

prescribed treatment to ascertain 

whether initial symptoms have 

resolved. 

The population data will be directly 

entered into existing STD surveillance 

information systems at each health 

department. Data will be locally 

extracted, de-identified and recoded 

into standardized formats prior to being 

transmitted to CDC through secure file 

transport mechanisms on bimonthly 

basis. Patient participation in the 

interview is voluntary and refusal to 

participate has no impact on other STD 

services the health department provides 

to persons diagnosed with gonorrhea. 

This project will not collect name, 

social security number, or date of birth. 

A Patient ID, a unique patient identifier 

assigned by the clinic or health 

department depending on the 

component, is requested and will be 

provided to CDC for purposes of 

enhanced surveillance. Patient IDs are 

not linkable across enhanced SSuN 

components. Sensitive information such 

as sex of sex partners, HIV status, sex 

work exposure, and injection drug use 

are collected. All personally identifiable 

information (PII) is retained by the STD 

clinics and/or health departments and is 

not recorded with data sent to CDC. The 

electronic enhanced SSuN database is 

stored on the CDC mainframe computer 

and only approved Division of STD 

Prevention (DSTDP) staff have access 

rights to the data. As part of the 

revision, we will continue to 

systematically identify the risks and 

potential effects of collecting, 

maintaining, and disseminating PII and 

to examine and evaluate alternative 

processes for handling that information 

to mitigate potential privacy risks and 

risks to confidentiality. 

Both components of enhanced SSuN 

are designed to (1) Integrate traditional 

surveillance methods with innovative 

data management technologies to 

produce high-quality, timely 

surveillance and epidemiologic data, (2) 

provide valuable information to direct 

public health STD prevention and 

control efforts, (3) enhance 

understanding of the community burden 

of disease, (4) identify syndemic 

patterns and population at greatest risk, 

and, (5) monitor long-term health 

consequences of STDs. The enhanced 

SSuN surveillance platform allows CDC 

to establish and maintain common 

standards for data collection, 

transmission, and analysis, and to build 

and maintain STD surveillance 

expertise in 10 state/local health 

departments. Such common systems, 

established mechanisms of 

communication, and in-place expertise 

are all critical components for timely, 

flexible, and high quality surveillance. 

The total estimated annual burden is 

3,479 hours. There are no costs to 

respondents other than their time. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Data manager at Sentinel STD clinics ........... Record Abstraction ......................................... 10 6 3 

General Public—Adults (persons diagnosed 

and reported with gonorrhea or early syphilis.

Interview ......................................................... 5492 1 10/60 

Diagnosing Provider ........................................ Data for early syphilis cases .......................... 406 1 10/60 

General Public—Adults (persons with early 

syphilis who were reported with neurologic/ 

ocular manifestations.

3 month follow-up telephone Interview .......... 203 1 5/60 

Data Managers: 10 local/state health department.Data cleaning/validation/reformatting ............. 10 12 19 


sradovich on DSK3GMQ082PROD with NOTICES
39102 Federal Register / Vol. 83, No. 153 / Wednesday, August 8, 2018 / Notices 

Jeffrey 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. 2018–16947 Filed 8–7–18; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–2485] 

Fougera Pharmaceuticals, Inc., et al.; 

Withdrawal of Approval of 27 

Abbreviated New Drug Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

withdrawing approval of 27 abbreviated 

new drug applications (ANDAs) from 

multiple applicants. The holders of the 

applications notified the Agency in 

writing that the drug products were no 

longer marketed and requested that the 

approval of the applications be 

withdrawn. 

DATES: Approval is withdrawn as of 

September 7, 2018. 

FOR FURTHER INFORMATION CONTACT: 

Trang Tran, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 75, Rm. 1671, Silver Spring, 

MD 20993–0002, 240–402–7945, 

Trang.Tran@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

holders of the applications listed in the 

table have informed FDA that these drug 

products are no longer marketed and 

have requested that FDA withdraw 

approval of the applications under the 

process described in § 314.150(c) (21 

CFR 314.150(c)). The applicants have 

also, by their requests, waived their 

opportunity for a hearing. Withdrawal 

of approval of an application or 

abbreviated application under 

§ 314.150(c) is without prejudice to 

refiling. 

Application No. Drug Applicant 

ANDA 061467 ......... Pyocidin-Otic (hydrocortisone and polymyxin B sulfate) Otic Solution, 5 milligrams (mg)/10,000 units per milliliter (mL).Fougera Pharmaceuticals, Inc., 60 

Baylis Rd., P.O. Box 2006, Melville, 

NY 11747. 

ANDA 061653 ......... Tetrex (tetracycline phosphate complex) Capsules, Equivalent to (EQ) 100 mg 

Hydrochloride (HCl), EQ 250 mg HCl and EQ 500 mg HCl.

Bristol-Myers Squibb Co., P.O. Box 

4000, Princeton, NJ 08543. 

ANDA 061658 ......... Bristacycline (tetracycline HCl) Capsules, 250 mg and 500 mg ........................... Do. 

ANDA 061711 ......... Penicillin V Potassium Tablets .............................................................................. Do. 

ANDA 061721 ......... Ampicillin Capsules, 250 mg and 500 mg ............................................................. Do. 

ANDA 061726 ......... Azotrex (phenazopyridine HCl, sulfamethizole and tetracycline phosphate complex) Capsules, 50 mg/250 mg/125 mg.Do. 

ANDA 061790 ......... Hetacillin Potassium ............................................................................................... Do. 

ANDA 061887 ......... Bristamycin (erythromycin stearate) Tablets, EQ 250 mg base ........................... Do. 

ANDA 061888 ......... Bristacycline (tetracycline HCl) Capsules, 250 mg and 500 mg ........................... Do. 

ANDA 061889 ......... Tetrex (tetracycline phosphate complex) Capsules, EQ 250 mg HCl and EQ 

500 mg HCl.

Do. 

ANDA 061890 ......... Azotrex (phenazopyridine HCl, sulfamethizole, and tetracycline) Capsules, 50 

mg/250 mg/125 mg.

Do. 

ANDA 061891 ......... Tetrex-S (tetracycline) Syrup, 125 mg/5 mL ......................................................... Do. 

ANDA 061975 ......... Cephradine Powder for Injection ........................................................................... Do. 

ANDA 062168 ......... Cephradine Tablets ................................................................................................ Do. 

ANDA 062259 ......... Amphotericin B for Use in Parenteral Products .................................................... Do. 

ANDA 062543 ......... Mycolog (nystatin, neomycin sulfate, gramicidin, and triamcinolone acetonide) 

Ointment.

Do. 

ANDA 071793 ......... Foamcoat (aluminum hydroxide; magnesium trisilicate) Chewable Tablets, 80 

mg/20 mg (OTC).

Guardian Drug Co., 2 Charles Court, 

Dayton, NJ 08810. 

ANDA 072035 ......... Nuprin (ibuprofen) Tablets, 200 mg ....................................................................... Bristol-Myers Squibb Co. 

ANDA 072036 ......... Nuprin (ibuprofen) Tablets, 200 mg ....................................................................... Do. 

ANDA 074911 ......... Phrenilin with Caffeine and Codeine (acetaminophen, butalbital, caffeine, and 

codeine phosphate) Capsules, 325 mg/50 mg/40 mg/30 mg.

Valeant Pharmaceuticals North America, LLC, 400 Somerset Corporate 

Blvd., Bridgewater, NJ 08807. 

ANDA 074944 ......... Atracurium Besylate Injection, 10 mg/mL .............................................................. Watson Laboratories, Inc., Subsidiary 

of Teva Pharmaceuticals USA, Inc., 

425 Privet Rd., Horsham, PA 19044. 

ANDA 075206 ......... Cytosar-U (cytarabine) for Injection USP, 100 mg/vial, 500 mg/vial, 1 gram (g)/ 

vial, and 2 g/vial.

Teva Pharmaceuticals USA, Inc., 425 

Privet Rd., Horsham, PA 19044. 

ANDA 077337 ......... Rosiglitazone Maleate and Metformin HCl Tablets, EQ 1 mg base/500 mg, EQ 

2 mg base/500 mg, EQ 4 mg base/500 mg, EQ 2 mg base/1 g, and EQ 4 mg 

base/1 g.

Do. 

ANDA 077930 ......... Meloxicam Tablets, 7.5 mg and 15 mg ................................................................. Impax Laboratories, Inc., 30831 

Huntwood Ave., Hayward, CA 94544. 

ANDA 080658 ......... Procaine HCl Injection, 1% and 2% ...................................................................... Watson Laboratories, Inc., Subsidiary 

of Teva Pharmaceuticals USA, Inc. 

ANDA 083128 ......... Hydrocortisone Acetate Injectable Suspension, 25 mg/mL ................................... Do. 

ANDA 090181 ......... Ifosfamide for Injection, 1 g/20 mL and 3 g/60 mL ............................................... Fresenius Kabi USA, LLC, Three Corporate Dr., Lake Zurich, IL 60047. 


sradovich on DSK3GMQ082PROD with NOTICES