82_FR_44367 82 FR 44185 - Department of Health and Human Services, Supply Service Center et al.; Withdrawal of Approval of 27 Abbreviated New Drug Applications

82 FR 44185 - Department of Health and Human Services, Supply Service Center et al.; Withdrawal of Approval of 27 Abbreviated New Drug Applications

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 182 (September 21, 2017)

Page Range44185-44187
FR Document2017-20107

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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

Federal Register, Volume 82 Issue 182 (Thursday, September 21, 2017) 
[Federal Register Volume 82, Number 182 (Thursday, September 21, 2017)]
[Notices]
[Pages 44185-44187]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-20107]


-----------------------------------------------------------------------

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that the approval of the applications be withdrawn.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.

[[Page 44186]]


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 Sec.  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 Sec.  314.150(c) is without prejudice to refiling.

                                 Table 1
------------------------------------------------------------------------
       Application No.                Drug                Applicant
------------------------------------------------------------------------
ANDA 061071.................  Tetracycline          Department of Health
                               Hydrochloride (HCl)   and Human Services,
                               Tablets, 250          Supply Service
                               milligrams (mg).      Center, PSC Bldg.
                                                     14 Boiler House
                                                     Rd., Perry Point,
                                                     MD 21902.
ANDA 062279.................  Grifulvin V           Valeant
                               (griseofulvin         Pharmaceuticals
                               microsize) Tablets    North America, LLC,
                               USP,125 mg, 250 mg,   400 Somerset
                               and 500 mg.           Corporate Blvd.,
                                                     Bridgewater, NJ
                                                     08807.
ANDA 062398.................  Cephalexin Capsules,  Department of Health
                               250 mg and 500 mg.    and Human Services,
                                                     Supply Service
                                                     Center, PSC Bldg.
                                                     14 Boiler House
                                                     Rd., Perry Point,
                                                     MD 21902.
ANDA 062756.................  Primaxin (cilastatin  Merck Sharp & Dohme
                               sodium and            Corp., Subsidiary
                               imipenem) for         of Merck & Co.,
                               Injection,            Inc., 1 Merck Dr.,
                               Equivalent to (EQ)    P.O. Box 100,
                               250 mg base/vial;     Whitehouse Station,
                               250 mg/vial and EQ    NJ 08889.
                               500 mg base/vial;
                               500 mg/vial.
ANDA 062814.................  Gentamicin Sulfate    B. Braun Medical
                               in 0.9% Sodium        Inc., 901 Marcon
                               Chloride Injection,   Blvd., Allentown,
                               EQ 0.8 mg base/       PA 18109.
                               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.
ANDA 063239.................  Rocephin              Hoffmann-La Roche,
                               (ceftriaxone          Inc., c/o Genentech
                               sodium) for           Inc., 1 DNA Way, MS
                               Injection USP, EQ     241B, South San
                               250 mg base/vial,     Francisco, CA
                               EQ 500 mg base/       94080.
                               vial, and EQ 1 gram
                               (g) base/vial.
ANDA 064127.................  Erythromycin Topical  Renaissance Pharma,
                               Solution, 2%.         Inc., 411 South
                                                     State St., Suite E-
                                                     100, Newton, PA
                                                     18940.
ANDA 064146.................  Amikacin Sulfate in   Hospira, Inc.,
                               Sodium Chloride       Subsidiary of
                               0.9% Injection, EQ    Pfizer Inc., 375 N.
                               500 mg base/100 mL.   Field Dr., Lake
                                                     Forest, IL 60045.
ANDA 070598.................  Metoclopramide HCl    Merck Sharp & Dohme
                               Tablets, EQ 10 mg     Corp., Subsidiary
                               base.                 of Merck & Co.,
                                                     Inc.
ANDA 072080.................  Furosemide Injection  Hospira, Inc.,
                               USP, 10 mg/mL.        Subsidiary of
                                                     Pfizer Inc.
ANDA 074601.................  Dipyridamole           Do.
                               Injection, 5 mg/mL.
ANDA 074720.................  Acyclovir Sodium       Do.
                               Injection, EQ 25 mg
                               base/mL.
ANDA 076564.................  Adenosine Injection   Teva Pharmaceuticals
                               USP, 3 mg/mL.         USA, Inc., 425
                                                     Privet Rd.,
                                                     Horsham, PA 19044.
ANDA 078211.................  Quinapril HCl and     Sun Pharmaceutical
                               Hydrochlorothiazide   Industries Ltd., c/
                               Tablets, EQ 10 mg     o Sun
                               base/12.5 mg, EQ 20   Pharmaceutical
                               mg base/12.5 mg,      Industries, Inc., 2
                               and EQ 20 mg base/    Independence Way,
                               25 mg.                Princeton, NJ
                                                     08540.
ANDA 078935.................  Tramadol HCl Tablets  Northstar Healthcare
                               USP, 50 mg.           Holdings, c/o
                                                     Quality Regulatory
                                                     Consultants, 1966
                                                     Anglers Cove, Vero
                                                     Beach, FL 32963.
ANDA 080810.................  Halothane USP,        Halocarbon Products
                               99.99%.               Corp., 1100 Dittman
                                                     Ct., North Augusta,
                                                     SC 29841.
ANDA 085458.................  Dexamethasone         Watson Laboratories,
                               Tablets USP, 0.5 mg.  Inc., Subsidiary of
                                                     Teva
                                                     Pharmaceuticals
                                                     USA, Inc., 425
                                                     Privet Rd.,
                                                     Horsham, PA 19044.
ANDA 085883.................  Acetaminophen and     Actavis Mid Atlantic
                               Codeine Phosphate     LLC, Subsidiary of
                               Oral Suspension       Teva
                               USP, 120 mg/5 mL      Pharmaceuticals
                               and 12 mg/5 mL.       USA, Inc., 425
                                                     Privet Rd.,
                                                     Horsham, PA 19044.
ANDA 085884.................  Cortisone Acetate     Watson Laboratories,
                               Tablets USP, 25 mg.   Inc., Subsidiary of
                                                     Teva
                                                     Pharmaceuticals
                                                     USA, Inc.
ANDA 086179.................  Carisoprodol Tablets   Do.
                               USP, 350 mg.
ANDA 086440.................  Atropine Sulfate and  Catalent Pharma
                               Diphenoxylate HCl     Solutions, Inc.,
                               Capsules, 0.025 mg/   2725 Scherer Dr.
                               2.5 mg.               North, St.
                                                     Petersburg, FL
                                                     33716.
ANDA 087535.................  Methylprednisolone    Organon USA, Inc.,
                               Sodium Succinate      Subsidiary of Merck
                               for Injection USP,    and Co., Inc., 126
                               EQ 500 mg base/vial   E. Lincoln Ave.,
                               and EQ 1 g base/      P.O. Box 2000,
                               vial.                 Rahway, NJ 07065.
ANDA 087711.................  Dexamethasone         Watson Laboratories,
                               Acetate Injectable    Inc., Subsidiary of
                               Suspension USP, EQ    Teva
                               16 mg base/mL.        Pharmaceuticals
                                                     USA, Inc.
ANDA 088346.................  Heparin Lock Flush    Hospira, Inc.
                               Solution USP and
                               0.9% Sodium
                               Chloride Injection
                               USP, 10 USP heparin
                               units/mL and 100
                               USP heparin units/
                               mL.
ANDA 088852.................  Chlorpropamide        Watson Laboratories,
                               Tablets USP, 100 mg.  Inc., Subsidiary of
                                                     Teva
                                                     Pharmaceuticals
                                                     USA, Inc.

[[Page 44187]]

 
ANDA 091201.................  Meropenem for         Sandoz Inc., 100
                               Injection USP, 500    College Rd. West,
                               mg/vial and 1 g/      Princeton, NJ
                               vial.                 08540.
ANDA 200156.................  Armodafinil Tablets,  Watson Laboratories,
                               100 mg and 200 mg.    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

Federal Register / Vol. 82, No. 182 / Thursday, September 21, 2017 / Notices 44185 little research on ASD in adolescence assembled with ASD. Children will be We estimate that 1,410 SEED families and adulthood. identified from four SEED sites in are potentially eligible to participate in While there is research showing that Georgia, Maryland, North Carolina, and SEED Teen. Reading the letter and other the majority of ASD diagnoses made in Pennsylvania. Three groups of children materials in the invitation mailing will early childhood are retained in will be included: Children with ASD, take approximately five minutes. We adolescence with mostly stable in children with other developmental estimate that a minimum of 60% of symptom severity, there are major gaps (non-ASD) conditions (DD comparison parents/caregivers will be sent the in our understanding of the health, group), and children from the general invitation mailing or will be functioning, and experiences of population who were initially sampled successfully contacted and participate adolescents with ASD and other from birth records (POP comparison in the invitation call (approximately 15 developmental disabilities. Many of group). minutes). We estimate that 80% of the these topics are especially relevant to families who participate in the public health: Adolescents and adults The children and parents previously enrolled in SEED 1 represent a unique invitation call will meet the eligibility with ASD have been shown to have criteria for SEED Teen and 70% of those frequent health problems, high opportunity to better understand the long term trajectory of children will enroll in SEED Teen. We assume all healthcare utilization and specialized enrolled families will complete the service needs, high caregiving burden, identified as having ASD at early ages. Mothers or other primary caregivers follow-up call to confirm data collection require substantial supports to perform packet receipt (approximately 10 daily activities, are likely to be bullied, who participated in SEED 1 will be re- contacted when their child is 13–17 minutes) and will review the materials or isolated from society, and are likely in the data collection packet. Finally, to have food allergies or put on years of age and asked to complete two self-administered questionnaires (SEED we estimate that 90% of enrolled restrictive diets of questionable benefit. Teen Health and Development Survey parents/caregivers will complete two Many of these problems emerge after and the Social Responsiveness Scale) self-administered questionnaires (SEED early childhood, and more studies are about their child’s health, development, Teen Health and Development Survey needed to estimate the frequency, education, and current functioning. and the Social Responsiveness Scale) severity, and predictive factors for these important outcomes in diverse cohorts Information from this study will allow and two supplemental consent forms. of individuals with autism and other researchers to assess the long term The two questionnaires will take developmental conditions. health and functioning of children with approximately 60 minutes to complete, SEED Teen is a follow-up study of ASD and other developmental plus an additional 5 minutes to read and children who participated in the first disabilities, family impacts associated sign the informed consent. Therefore, phase of the SEED case-control study with ASD and other DDs, and service we estimate the total burden hours are (SEED 1) in 2007–2011 when they were needs and use associated with having 303. 2 to 5 years of age. SEED includes one and ASD and other DDs, particularly There are no costs to participants of the largest cohorts of children during the teen years. other than their time. ESTIMATED ANNUALIZED BURDEN HOURS Average Number of Number of burden per Type of respondents Form name responses per respondents response respondent (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 Follow-up Call ................................................ 158 1 10/60 Teen. Families who agreed to participate in SEED Data Collection Packet ................................... 158 1 5/60 Teen. Families who agreed to participate in SEED SEED Teen Health and Development Survey 142 1 40/60 Teen. Families who agreed to participate in SEED Social Responsive-ness Scale ....................... 142 1 20/60 Teen. Families who agreed to participate in SEED Supplemental Consent forms ......................... 142 1 5/60 Teen. Leroy A. Richardson, DEPARTMENT OF HEALTH AND ACTION: Notice. Chief, Information Collection Review Office, HUMAN SERVICES Office of Scientific Integrity, Office of the SUMMARY: The Food and Drug Associate Director for Science, Office of the Food and Drug Administration Administration (FDA) is withdrawing Director, Centers for Disease Control and approval of 27 abbreviated new drug asabaliauskas on DSKBBXCHB2PROD with NOTICES Prevention. [Docket No. FDA–2017–N–5526] applications (ANDAs) from multiple [FR Doc. 2017–20067 Filed 9–20–17; 8:45 am] applicants. The holders of the BILLING CODE 4163–18–P Department of Health and Human applications notified the Agency in Services, Supply Service Center et al.; writing that the drug products were no Withdrawal of Approval of 27 longer marketed and requested that the Abbreviated New Drug Applications approval of the applications be withdrawn. AGENCY: Food and Drug Administration, HHS. DATES: Applied Date: October 23, 2017. VerDate Sep<11>2014 17:52 Sep 20, 2017 Jkt 241001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 E:\FR\FM\21SEN1.SGM 21SEN1

44186 Federal Register / Vol. 82, No. 182 / Thursday, September 21, 2017 / Notices FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: The 314.150(c)). The applicants have also, Trang Tran, Center for Drug Evaluation holders of the applications listed in by their requests, waived their and Research, Food and Drug table 1 have informed FDA that these opportunity for a hearing. Withdrawal Administration, 10903 New Hampshire drug products are no longer marketed of approval of an abbreviated Ave., Bldg. 75, Rm. 1671, Silver Spring, and have requested that FDA withdraw application under § 314.150(c) is MD 20993–0002, 240–402–7945. approval of the applications under the without prejudice to refiling. process in § 314.150(c) (21 CFR TABLE 1 Application No. Drug Applicant ANDA 061071 ...................... Tetracycline Hydrochloride (HCl) Tablets, 250 milli- Department of Health and Human Services, Supply grams (mg). Service Center, PSC Bldg. 14 Boiler House Rd., Perry Point, MD 21902. ANDA 062279 ...................... Grifulvin V (griseofulvin microsize) Tablets USP,125 Valeant Pharmaceuticals North America, LLC, 400 mg, 250 mg, and 500 mg. 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, Merck Sharp & Dohme Corp., Subsidiary of Merck & Equivalent to (EQ) 250 mg base/vial; 250 mg/vial and Co., Inc., 1 Merck Dr., P.O. Box 100, Whitehouse EQ 500 mg base/vial; 500 mg/vial. Station, NJ 08889. ANDA 062814 ...................... Gentamicin Sulfate in 0.9% Sodium Chloride Injection, B. Braun Medical Inc., 901 Marcon Blvd., Allentown, PA EQ 0.8 mg base/milliliter (mL), EQ 1.2 mg base/mL, 18109. 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. ANDA 063239 ...................... Rocephin (ceftriaxone sodium) for Injection USP, EQ Hoffmann-La Roche, Inc., c/o Genentech Inc., 1 DNA 250 mg base/vial, EQ 500 mg base/vial, and EQ 1 Way, MS 241B, South San Francisco, CA 94080. gram (g) base/vial. 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, Hospira, Inc., Subsidiary of Pfizer Inc., 375 N. Field Dr., EQ 500 mg base/100 mL. 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 Sun Pharmaceutical Industries Ltd., c/o Sun Pharma- mg base/12.5 mg, EQ 20 mg base/12.5 mg, and EQ ceutical Industries, Inc., 2 Independence Way, 20 mg base/25 mg. 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 Pharma- ceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044. ANDA 085883 ...................... Acetaminophen and Codeine Phosphate Oral Suspen- Actavis Mid Atlantic LLC, Subsidiary of Teva Pharma- sion USP, 120 mg/5 mL and 12 mg/5 mL. ceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044. ANDA 085884 ...................... Cortisone Acetate Tablets USP, 25 mg .......................... Watson Laboratories, Inc., Subsidiary of Teva Pharma- ceuticals USA, Inc. ANDA 086179 ...................... Carisoprodol Tablets USP, 350 mg ................................ Do. ANDA 086440 ...................... Atropine Sulfate and Diphenoxylate HCl Capsules, Catalent Pharma Solutions, Inc., 2725 Scherer Dr. 0.025 mg/2.5 mg. North, St. Petersburg, FL 33716. ANDA 087535 ...................... Methylprednisolone Sodium Succinate for Injection Organon USA, Inc., Subsidiary of Merck and Co., Inc., asabaliauskas on DSKBBXCHB2PROD with NOTICES USP, EQ 500 mg base/vial and EQ 1 g base/vial. 126 E. Lincoln Ave., P.O. Box 2000, Rahway, NJ 07065. ANDA 087711 ...................... Dexamethasone Acetate Injectable Suspension USP, Watson Laboratories, Inc., Subsidiary of Teva Pharma- EQ 16 mg base/mL. ceuticals USA, Inc. ANDA 088346 ...................... Heparin Lock Flush Solution USP and 0.9% Sodium Hospira, Inc. Chloride Injection USP, 10 USP heparin units/mL and 100 USP heparin units/mL. ANDA 088852 ...................... Chlorpropamide Tablets USP, 100 mg ........................... Watson Laboratories, Inc., Subsidiary of Teva Pharma- ceuticals USA, Inc. VerDate Sep<11>2014 17:52 Sep 20, 2017 Jkt 241001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 E:\FR\FM\21SEN1.SGM 21SEN1

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 Pharma- ceuticals USA, Inc. Therefore, approval of the ADDRESSES: FDA White Oak Campus, that if you include your name, contact applications listed in table 1, and all 10903 New Hampshire Ave., Bldg. 31 information, or other information that amendments and supplements thereto, Conference Center, the Great Room (Rm. identifies you in the body of your is hereby withdrawn, effective October 1503), Silver Spring, MD 20993–0002. comments, that information will be 23, 2017. Introduction or delivery for Answers to commonly asked questions posted on https://www.regulations.gov. introduction into interstate commerce of including information regarding special • If you want to submit a comment products without approved new drug accommodations due to a disability, with confidential information that you applications violates section 301(a) and visitor parking, and transportation may do not wish to be made available to the (d) of the Federal Food, Drug, and be accessed at: https://www.fda.gov/ public, submit the comment as a Cosmetic Act (21 U.S.C. 331(a) and (d)). AdvisoryCommittees/ written/paper submission and in the Drug products that are listed in table 1 AboutAdvisoryCommittees/ manner detailed (see ‘‘Written/Paper that are in inventory on the date that ucm408555.htm. Submissions’’ and ‘‘Instructions’’). this notice becomes effective (see the FDA is establishing a docket for Written/Paper Submissions DATES section) may continue to be public comment on this meeting. The dispensed until the inventories have docket number is FDA–2017–N–5255. Submit written/paper submissions as been depleted or the drug products have The docket will close on October 12, follows: reached their expiration dates or 2017. Submit either electronic or • Mail/Hand delivery/Courier (for otherwise become violative, whichever written comments on this public written/paper submissions): Dockets occurs first. meeting by October 12, 2017. Late, Management Staff (HFA–305), Food and untimely filed comments will not be Drug Administration, 5630 Fishers Dated: September 15, 2017. Lane, Rm. 1061, Rockville, MD 20852. considered. Electronic comments must Anna K. Abram, be submitted on or before October 12, • For written/paper comments Deputy Commissioner for Policy, Planning, submitted to the Dockets Management 2017. The https://www.regulations.gov Legislation, and Analysis. Staff, FDA will post your comment, as electronic filing system will accept [FR Doc. 2017–20107 Filed 9–20–17; 8:45 a.m.] comments until midnight Eastern Time well as any attachments, except for BILLING CODE 4164–01–P at the end of October 12, 2017. information submitted, marked and Comments received by mail/hand identified, as confidential, if submitted delivery/courier (for written/paper as detailed in ‘‘Instructions.’’ DEPARTMENT OF HEALTH AND Instructions: All submissions received submissions) will be considered timely HUMAN SERVICES must include the Docket No. FDA– if they are postmarked or the delivery service acceptance receipt is on or 2017–N–5255 for ‘‘Dermatologic and Food and Drug Administration Ophthalmic Drugs Advisory Committee; before that date. [Docket No. FDA–2017–N–5255] Comments received on or before Notice of Meeting; Establishment of a September 28, 2017, will be provided to Public Docket; Request for Comments.’’ Dermatologic and Ophthalmic Drugs the committee. Comments received after Received comments, those filed in a Advisory Committee; Notice of that date will be taken into timely manner (see ADDRESSES), will be Meeting; Establishment of a Public consideration by the Agency. placed in the docket and, except for Docket; Request for Comments You may submit comments as those submitted as ‘‘Confidential follows: Submissions,’’ publicly viewable at AGENCY: Food and Drug Administration, https://www.regulations.gov or at the HHS. Electronic Submissions Dockets Management Staff between 9 ACTION: Notice; establishment of a Submit electronic comments in the a.m. and 4 p.m., Monday through public docket; request for comments. following way: Friday. • Federal eRulemaking Portal: • Confidential Submissions—To SUMMARY: The Food and Drug https://www.regulations.gov. Follow the submit a comment with confidential Administration (FDA or Agency) instructions for submitting comments. information that you do not wish to be announces a forthcoming public Comments submitted electronically, made publicly available, submit your advisory committee meeting of the including attachments, to https:// comments only as a written/paper Dermatologic and Ophthalmic Drugs www.regulations.gov will be posted to submission. You should submit two Advisory Committee. The general the docket unchanged. Because your copies total. One copy will include the function of the committee is to provide asabaliauskas on DSKBBXCHB2PROD with NOTICES comment will be made public, you are information you claim to be confidential advice and recommendations to the solely responsible for ensuring that your with a heading or cover note that states Agency on FDA’s regulatory issues. The comment does not include any ‘‘THIS DOCUMENT CONTAINS meeting will be open to the public. FDA confidential information that you or a CONFIDENTIAL INFORMATION.’’ The is establishing a docket for public third party may not wish to be posted, Agency will review this copy, including comment on this document. such as medical information, your or the claimed confidential information, in DATES: The public meeting will be held anyone else’s Social Security number, or its consideration of comments. The on October 13, 2017, from 8:30 a.m. to confidential business information, such second copy, which will have the 4 p.m. as a manufacturing process. Please note claimed confidential information VerDate Sep<11>2014 17:52 Sep 20, 2017 Jkt 241001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 E:\FR\FM\21SEN1.SGM 21SEN1


Document Created: 2018-10-24 14:34:01
Document Modified: 2018-10-24 14:34:01
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesApplied Date: October 23, 2017.
ContactTrang 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.
FR Citation82 FR 44185 
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