Federal Register / Vol. 82, No. 182 / Thursday, September 21, 2017 / Notices 44185 

little research on ASD in adolescence 

and adulthood. 

While there is research showing that 

the majority of ASD diagnoses made in 

early childhood are retained in 

adolescence with mostly stable in 

symptom severity, there are major gaps 

in our understanding of the health, 

functioning, and experiences of 

adolescents with ASD and other 

developmental disabilities. Many of 

these topics are especially relevant to 

public health: Adolescents and adults 

with ASD have been shown to have 

frequent health problems, high 

healthcare utilization and specialized 

service needs, high caregiving burden, 

require substantial supports to perform 

daily activities, are likely to be bullied, 

or isolated from society, and are likely 

to have food allergies or put on 

restrictive diets of questionable benefit. 

Many of these problems emerge after 

early childhood, and more studies are 

needed to estimate the frequency, 

severity, and predictive factors for these 

important outcomes in diverse cohorts 

of individuals with autism and other 

developmental conditions. 

SEED Teen is a follow-up study of 

children who participated in the first 

phase of the SEED case-control study 

(SEED 1) in 2007–2011 when they were 

2 to 5 years of age. SEED includes one 

of the largest cohorts of children 

assembled with ASD. Children will be 

identified from four SEED sites in 

Georgia, Maryland, North Carolina, and 

Pennsylvania. Three groups of children 

will be included: Children with ASD, 

children with other developmental 

(non-ASD) conditions (DD comparison 

group), and children from the general 

population who were initially sampled 

from birth records (POP comparison 

group). 

The children and parents previously 

enrolled in SEED 1 represent a unique 

opportunity to better understand the 

long term trajectory of children 

identified as having ASD at early ages. 

Mothers or other primary caregivers 

who participated in SEED 1 will be recontacted when their child is 13–17 

years of age and asked to complete two 

self-administered questionnaires (SEED 

Teen Health and Development Survey 

and the Social Responsiveness Scale) 

about their child’s health, development, 

education, and current functioning. 

Information from this study will allow 

researchers to assess the long term 

health and functioning of children with 

ASD and other developmental 

disabilities, family impacts associated 

with ASD and other DDs, and service 

needs and use associated with having 

and ASD and other DDs, particularly 

during the teen years. 

We estimate that 1,410 SEED families 

are potentially eligible to participate in 

SEED Teen. Reading the letter and other 

materials in the invitation mailing will 

take approximately five minutes. We 

estimate that a minimum of 60% of 

parents/caregivers will be sent the 

invitation mailing or will be 

successfully contacted and participate 

in the invitation call (approximately 15 

minutes). We estimate that 80% of the 

families who participate in the 

invitation call will meet the eligibility 

criteria for SEED Teen and 70% of those 

will enroll in SEED Teen. We assume all 

enrolled families will complete the 

follow-up call to confirm data collection 

packet receipt (approximately 10 

minutes) and will review the materials 

in the data collection packet. Finally, 

we estimate that 90% of enrolled 

parents/caregivers will complete two 

self-administered questionnaires (SEED 

Teen Health and Development Survey 

and the Social Responsiveness Scale) 

and two supplemental consent forms. 

The two questionnaires will take 

approximately 60 minutes to complete, 

plus an additional 5 minutes to read and 

sign the informed consent. Therefore, 

we estimate the total burden hours are 

303. 

There are no costs to participants 

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) 

Eligible families who were enrolled in SEED 1 Invitation Packet ............................................. 470 1 5/60 

Eligible families who were enrolled in SEED 1 Invitation Call Script ....................................... 282 1 15/60 

Families who agreed to participate in SEED 

Teen.

Follow-up Call ................................................ 158 1 10/60 

Families who agreed to participate in SEED 

Teen.

Data Collection Packet ................................... 158 1 5/60 

Families who agreed to participate in SEED 

Teen.

SEED Teen Health and Development Survey 142 1 40/60 

Families who agreed to participate in SEED 

Teen.

Social Responsive-ness Scale ....................... 142 1 20/60 

Families who agreed to participate in SEED 

Teen.

Supplemental Consent forms ......................... 142 1 5/60 

Leroy A. Richardson, 

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. 2017–20067 Filed 9–20–17; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–5526] 

Department of Health and Human 

Services, Supply Service Center 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) 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: Applied Date: October 23, 2017. 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
44186 Federal Register / Vol. 82, No. 182 / Thursday, September 21, 2017 / Notices 

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. 

SUPPLEMENTARY INFORMATION: The 

holders of the applications listed in 

table 1 have informed FDA that these 

drug products are no longer marketed 

and have requested that FDA withdraw 

approval of the applications under the 

process 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 abbreviated 

application under § 314.150(c) is 

without prejudice to refiling. 

TABLE 1 

Application No. Drug Applicant 

ANDA 061071 ...................... Tetracycline Hydrochloride (HCl) Tablets, 250 milligrams (mg).Department of Health and Human Services, Supply 

Service Center, PSC Bldg. 14 Boiler House Rd., 

Perry Point, MD 21902. 

ANDA 062279 ...................... Grifulvin V (griseofulvin microsize) Tablets USP,125 

mg, 250 mg, and 500 mg.

Valeant Pharmaceuticals North America, LLC, 400 

Somerset Corporate Blvd., Bridgewater, NJ 08807. 

ANDA 062398 ...................... Cephalexin Capsules, 250 mg and 500 mg ................... Department of Health and Human Services, Supply 

Service Center, PSC Bldg. 14 Boiler House Rd., 

Perry Point, MD 21902. 

ANDA 062756 ...................... Primaxin (cilastatin sodium and imipenem) for Injection, 

Equivalent to (EQ) 250 mg base/vial; 250 mg/vial and 

EQ 500 mg base/vial; 500 mg/vial.

Merck Sharp & Dohme Corp., Subsidiary of Merck & 

Co., Inc., 1 Merck Dr., P.O. Box 100, Whitehouse 

Station, NJ 08889. 

ANDA 062814 ...................... Gentamicin Sulfate in 0.9% Sodium Chloride Injection, 

EQ 0.8 mg base/milliliter (mL), EQ 1.2 mg base/mL, 

EQ 1.4 mg base/mL, EQ 1.6 mg base/mL, EQ 1.8 

mg base/mL, EQ 2 mg base/mL, EQ 2.4 mg base/ 

mL, EQ 40 mg base/100 mL, EQ 60 mg base/100 

mL, EQ 70 mg base/100 mL, EQ 80 mg base/100 

mL, EQ 90 mg base/100 mL, EQ 100 mg base/100 

mL, and EQ 120 mg base/100 mL.

B. Braun Medical Inc., 901 Marcon Blvd., Allentown, PA 

18109. 

ANDA 063239 ...................... Rocephin (ceftriaxone sodium) for Injection USP, EQ 

250 mg base/vial, EQ 500 mg base/vial, and EQ 1 

gram (g) base/vial.

Hoffmann-La Roche, Inc., c/o Genentech Inc., 1 DNA 

Way, MS 241B, South San Francisco, CA 94080. 

ANDA 064127 ...................... Erythromycin Topical Solution, 2% ................................. Renaissance Pharma, Inc., 411 South State St., Suite 

E–100, Newton, PA 18940. 

ANDA 064146 ...................... Amikacin Sulfate in Sodium Chloride 0.9% Injection, 

EQ 500 mg base/100 mL.

Hospira, Inc., Subsidiary of Pfizer Inc., 375 N. Field Dr., 

Lake Forest, IL 60045. 

ANDA 070598 ...................... Metoclopramide HCl Tablets, EQ 10 mg base ............... Merck Sharp & Dohme Corp., Subsidiary of Merck & 

Co., Inc. 

ANDA 072080 ...................... Furosemide Injection USP, 10 mg/mL ............................ Hospira, Inc., Subsidiary of Pfizer Inc. 

ANDA 074601 ...................... Dipyridamole Injection, 5 mg/mL .................................... Do. 

ANDA 074720 ...................... Acyclovir Sodium Injection, EQ 25 mg base/mL ............ Do. 

ANDA 076564 ...................... Adenosine Injection USP, 3 mg/mL ................................ Teva Pharmaceuticals USA, Inc., 425 Privet Rd., 

Horsham, PA 19044. 

ANDA 078211 ...................... Quinapril HCl and Hydrochlorothiazide Tablets, EQ 10 

mg base/12.5 mg, EQ 20 mg base/12.5 mg, and EQ 

20 mg base/25 mg.

Sun Pharmaceutical Industries Ltd., c/o Sun Pharmaceutical Industries, Inc., 2 Independence Way, 

Princeton, NJ 08540. 

ANDA 078935 ...................... Tramadol HCl Tablets USP, 50 mg ................................ Northstar Healthcare Holdings, c/o Quality Regulatory 

Consultants, 1966 Anglers Cove, Vero Beach, FL 

32963. 

ANDA 080810 ...................... Halothane USP, 99.99% ................................................. Halocarbon Products Corp., 1100 Dittman Ct., North 

Augusta, SC 29841. 

ANDA 085458 ...................... Dexamethasone Tablets USP, 0.5 mg ........................... Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 

19044. 

ANDA 085883 ...................... Acetaminophen and Codeine Phosphate Oral Suspension USP, 120 mg/5 mL and 12 mg/5 mL.Actavis Mid Atlantic LLC, Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 

19044. 

ANDA 085884 ...................... Cortisone Acetate Tablets USP, 25 mg .......................... Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. 

ANDA 086179 ...................... Carisoprodol Tablets USP, 350 mg ................................ Do. 

ANDA 086440 ...................... Atropine Sulfate and Diphenoxylate HCl Capsules, 

0.025 mg/2.5 mg.

Catalent Pharma Solutions, Inc., 2725 Scherer Dr. 

North, St. Petersburg, FL 33716. 

ANDA 087535 ...................... Methylprednisolone Sodium Succinate for Injection 

USP, EQ 500 mg base/vial and EQ 1 g base/vial.

Organon USA, Inc., Subsidiary of Merck and Co., Inc., 

126 E. Lincoln Ave., P.O. Box 2000, Rahway, NJ 

07065. 

ANDA 087711 ...................... Dexamethasone Acetate Injectable Suspension USP, 

EQ 16 mg base/mL.

Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. 

ANDA 088346 ...................... Heparin Lock Flush Solution USP and 0.9% Sodium 

Chloride Injection USP, 10 USP heparin units/mL and 

100 USP heparin units/mL.

Hospira, Inc. 

ANDA 088852 ...................... Chlorpropamide Tablets USP, 100 mg ........................... Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
Federal Register / Vol. 82, No. 182 / Thursday, September 21, 2017 / Notices 44187 

TABLE 1—Continued 

Application No. Drug Applicant 

ANDA 091201 ...................... Meropenem for Injection USP, 500 mg/vial and 1 g/vial Sandoz Inc., 100 College Rd. West, Princeton, NJ 

08540. 

ANDA 200156 ...................... Armodafinil Tablets, 100 mg and 200 mg ...................... Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. 

Therefore, approval of the 

applications listed in table 1, and all 

amendments and supplements thereto, 

is hereby withdrawn, effective October 

23, 2017. Introduction or delivery for 

introduction into interstate commerce of 

products without approved new drug 

applications violates section 301(a) and 

(d) of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 331(a) and (d)). 

Drug products that are listed in table 1 

that are in inventory on the date that 

this notice becomes effective (see the 

DATES section) may continue to be 

dispensed until the inventories have 

been depleted or the drug products have 

reached their expiration dates or 

otherwise become violative, whichever 

occurs first. 

Dated: September 15, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–20107 Filed 9–20–17; 8:45 a.m.] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–5255] 

Dermatologic and Ophthalmic Drugs 

Advisory Committee; Notice of 

Meeting; Establishment of a Public 

Docket; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; establishment of a 

public docket; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) 

announces a forthcoming public 

advisory committee meeting of the 

Dermatologic and Ophthalmic Drugs 

Advisory Committee. The general 

function of the committee is to provide 

advice and recommendations to the 

Agency on FDA’s regulatory issues. The 

meeting will be open to the public. FDA 

is establishing a docket for public 

comment on this document. 

DATES: The public meeting will be held 

on October 13, 2017, from 8:30 a.m. to 

4 p.m. 

ADDRESSES: FDA White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31 

Conference Center, the Great Room (Rm. 

1503), Silver Spring, MD 20993–0002. 

Answers to commonly asked questions 

including information regarding special 

accommodations due to a disability, 

visitor parking, and transportation may 

be accessed at: https://www.fda.gov/ 

AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm408555.htm. 

FDA is establishing a docket for 

public comment on this meeting. The 

docket number is FDA–2017–N–5255. 

The docket will close on October 12, 

2017. Submit either electronic or 

written comments on this public 

meeting by October 12, 2017. Late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before October 12, 

2017. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of October 12, 2017. 

Comments 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 that date. 

Comments received on or before 

September 28, 2017, will be provided to 

the committee. Comments received after 

that date will be taken into 

consideration by the Agency. 

You may submit comments as 

follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• 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– 

2017–N–5255 for ‘‘Dermatologic and 

Ophthalmic Drugs Advisory Committee; 

Notice of Meeting; Establishment of a 

Public Docket; Request for Comments.’’ 

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. 

• 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 


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