83 FR 10493 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments; Correction

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 47 (March 9, 2018)

Page Range		10493-10493
FR Document		2018-04774

The Food and Drug Administration is correcting a notice entitled ``Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments'' that appeared in the Federal Register of February 22, 2018. The document was published with the incorrect docket number. This document corrects that error.

Federal Register, Volume 83 Issue 47 (Friday, March 9, 2018)

[Federal Register Volume 83, Number 47 (Friday, March 9, 2018)]
[Notices]
[Page 10493]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-04774]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0410]


Peripheral and Central Nervous System Drugs Advisory Committee; 
Notice of Meeting; Establishment of a Public Docket; Request for 
Comments; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; request for comments; 
correction.

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

SUMMARY: The Food and Drug Administration is correcting a notice 
entitled ``Peripheral and Central Nervous System Drugs Advisory 
Committee; Notice of Meeting; Establishment of a Public Docket; Request 
for Comments'' that appeared in the Federal Register of February 22, 
2018. The document was published with the incorrect docket number. This 
document corrects that error.

FOR FURTHER INFORMATION CONTACT: Lisa Granger, Office of Policy and 
Planning, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
32, Rm. 3330, Silver Spring, MD 20993-0002, 301-796-9115.

SUPPLEMENTARY INFORMATION: In the Federal Register of Thursday, 
February 22, 2018 (83 FR 7727), in FR Doc. 2018-03603, on page 7727, 
the following correction is made:
    1. On page 7727, in the first column, in the header of the 
document, the docket number is corrected to read ``FDA-2018-N-0410.''

    Dated: March 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-04774 Filed 3-8-18; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 47 / Friday, March 9, 2018 / Notices 10493

17. Meeting Summary and Attachment from Committee; Notice of Meeting; Restoration Act of 1984 (Pub. L. 98–417)
the U.S.-EU Bivalve Molluscan Shellfish Establishment of a Public Docket; (the 1984 amendments), which
Equivalence Project. November 19–20, Request for Comments’’ that appeared in authorized the approval of duplicate
2015. FDA Hillandale Building, Silver the Federal Register of February 22, versions of drug products under an
Spring, MD.
18. Commission Regulation (EU) 2015/2285
2018. The document was published ANDA procedure. ANDA applicants
of 8 December 2015 Amending Annex II with the incorrect docket number. This must, with certain exceptions, show that
to Regulation (EC) No. 854/2004 of the document corrects that error. the drug for which they are seeking
European Parliament. Accessed online at FOR FURTHER INFORMATION CONTACT: Lisa approval contains the same active
http://eur-lex.europa.eu/legal-content/ Granger, Office of Policy and Planning, ingredient in the same strength and
EN/TXT/PDF/?uri=CELEX:32015R2285 Food and Drug Administration, 10903 dosage form as the ‘‘listed drug,’’ which
&from=EN. New Hampshire Ave., Bldg. 32, Rm. is a version of the drug that was
19. Meeting Summary and Attachment from previously approved. ANDA applicants
3330, Silver Spring, MD 20993–0002,
the U.S.-EU Bivalve Molluscan Shellfish do not have to repeat the extensive
Equivalence Project. September 19–20, 301–796–9115.
SUPPLEMENTARY INFORMATION: In the clinical testing otherwise necessary to
2016. FDA Center for Food Safety and
Applied Nutrition, College Park, MD. Federal Register of Thursday, February gain approval of a new drug application
20. Bad Bug Book, Foodborne Pathogenic 22, 2018 (83 FR 7727), in FR Doc. 2018– (NDA).
Microorganisms and Natural Toxins. The 1984 amendments include what
03603, on page 7727, the following
Second Edition. FDA. 2012. Accessed is now section 505(j)(7) of the Federal
correction is made:
online at https://www.fda.gov/food/ 1. On page 7727, in the first column, Food, Drug, and Cosmetic Act (21 U.S.C.
foodborneillnesscontaminants/ in the header of the document, the 355(j)(7)), which requires FDA to
causesofillnessbadbugbook/.
docket number is corrected to read publish a list of all approved drugs.
21. Risk Assessment of Vibrio vulnificus in FDA publishes this list as part of the
Raw Oysters, Interpretive Summary and ‘‘FDA–2018–N–0410.’’
‘‘Approved Drug Products With
Technical Report. World Health Dated: March 5, 2018. Therapeutic Equivalence Evaluations,’’
Organization/Food and Agriculture Leslie Kux, which is known generally as the
Organization of the United Nations.
2005. Accessed online at http://
Associate Commissioner for Policy. ‘‘Orange Book.’’ Under FDA regulations,
www.who.int/foodsafety/publications/ [FR Doc. 2018–04774 Filed 3–8–18; 8:45 am] drugs are removed from the list if the
micro/mra8.pdf. BILLING CODE 4164–01–P Agency withdraws or suspends
22. Meeting Summary and Attachments from approval of the drug’s NDA or ANDA
the U.S.-EU Molluscan Shellfish for reasons of safety or effectiveness or
Equivalence Project. September 5–6, DEPARTMENT OF HEALTH AND if FDA determines that the listed drug
2013. FDA White Oak Campus, Silver HUMAN SERVICES was withdrawn from sale for reasons of
Spring, MD. safety or effectiveness (§ 314.162 (21
23. On-going Activities on Emerging Risks in Food and Drug Administration CFR 314.162)).
the SCER Unit. Presentation at European A person may petition the Agency to
Food Safety Authority (EFSA) 56th [Docket No. FDA–2017–P–5946]
determine, or the Agency may
Advisory Forum Meeting. June 11–12,
2015. Accessed online at https:// Determination That DORYX MPC determine on its own initiative, whether
www.efsa.europa.eu/sites/default/files/ (Doxycycline Hyclate), Delayed- a listed drug was withdrawn from sale
assets/af150611a-p9d.pdf. Release Tablets, 60 Milligrams, Were for reasons of safety or effectiveness.
Not Withdrawn From Sale for Reasons This determination may be made at any
Dated: March 6, 2018. of Safety or Effectiveness time after the drug has been withdrawn
Leslie Kux, from sale, but must be made prior to
Associate Commissioner for Policy.
AGENCY: Food and Drug Administration, approving an ANDA that refers to the
HHS. listed drug (§ 314.161 (21 CFR 314.161)).
[FR Doc. 2018–04772 Filed 3–8–18; 8:45 am]
ACTION: Notice. FDA may not approve an ANDA that
BILLING CODE 4164–01–P
does not refer to a listed drug.
SUMMARY: The Food and Drug DORYX MPC (doxycycline hyclate),
Administration (FDA or Agency) has delayed-release tablets, 60 mg, are the
DEPARTMENT OF HEALTH AND determined that DORYX MPC
HUMAN SERVICES subject of NDA 50–795, held by Mayne
(doxycycline hyclate), delayed-release Pharma International Pty Ltd., and
tablets, 60 milligrams (mg), were not initially approved on May 6, 2005.
Food and Drug Administration
withdrawn from sale for reasons of DORYX MPC is indicated for rickettsial
[Docket No. FDA–2018–N–0410] safety or effectiveness. This infections; sexually transmitted
determination will allow FDA to infections; respiratory tract infections;
Peripheral and Central Nervous approve abbreviated new drug
System Drugs Advisory Committee; specific bacterial infections; ophthalmic
applications (ANDAs) for DORYX MPC infections; anthrax, including
Notice of Meeting; Establishment of a (doxycycline hyclate), delayed-release
Public Docket; Request for Comments; inhalational anthrax (post-exposure);
tablets, 60 mg, if all other legal and alternative treatment for selected
Correction regulatory requirements are met. infections when penicillin is
AGENCY: Food and Drug Administration, FOR FURTHER INFORMATION CONTACT: contraindicated; adjunctive therapy in
HHS. Aaron Young, Center for Drug acute intestinal amebiasis and severe
ACTION: Notice; establishment of a Evaluation and Research, Food and acne; and prophylaxis of malaria.
amozie on DSK30RV082PROD with NOTICES

public docket; request for comments; Drug Administration, 10903 New Mayne Pharma International Pty Ltd.
correction. Hampshire Ave., Bldg. 51, Rm. 6217, has never marketed DORYX MPC
Silver Spring, MD 20993–0002, 301– (doxycycline hyclate), delayed-release
SUMMARY: The Food and Drug 796–8083. tablets, 60 mg. In previous instances
Administration is correcting a notice SUPPLEMENTARY INFORMATION: In 1984, (see, e.g., 72 FR 9763 (March 5, 2007)
entitled ‘‘Peripheral and Central Congress enacted the Drug Price and 61 FR 25497 (May 21, 1996)), the
Nervous System Drugs Advisory Competition and Patent Term Agency has determined that, for

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Document Created: 2018-03-09 03:48:42
Document Modified: 2018-03-09 03:48:42

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice; establishment of a public docket; request for comments; correction.
Contact		Lisa Granger, Office of Policy and Planning, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3330, Silver Spring, MD 20993-0002, 301-796-9115.
FR Citation		83 FR 10493

83 FR 10493 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments; Correction

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 47 (March 9, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration