81 FR 89470 - Determination That SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER (Sodium Chloride), Injectable, 234 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 238 (December 12, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 238 (December 12, 2016)
| Page Range | 89470-89471 | |
| FR Document | 2016-29674 |
[Federal Register Volume 81, Number 238 (Monday, December 12, 2016)] [Notices] [Pages 89470-89471] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-29674] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-P-1363] Determination That SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER (Sodium Chloride), Injectable, 234 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS.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 SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER (sodium chloride), injectable, 234 milligrams (mg)/milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for sodium chloride, injectable, 234 mg/mL, if all other legal and regulatory requirements are met. FOR FURTHER INFORMATION CONTACT: David Faranda, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6213, Silver Spring, MD 20993-0002, 301- 796-8767. 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 (Sec. 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug. SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER (sodium chloride), injectable, 234 mg/mL, is the subject of NDA 019329, held by Abraxis Pharmaceutical Products, and initially approved on April 22, 1987. SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER is indicated for use in patients who have special problems of sodium electrolyte intake or excretion, and for the treatment of sodium chloride and water deficiencies, which commonly occur in many diseases. In a letter dated January 18, 1996, the original NDA holder, Fujisawa USA, Inc., notified FDA that SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER (sodium chloride), injectable, 234 mg/mL, was being discontinued, and FDA moved the drug product to the ``Discontinued Drug [[Page 89471]] Product List'' section of the Orange Book. Gordon Johnston Regulatory Consultants, LLC, submitted a citizen petition dated May 25, 2016 (Docket No. FDA-2016-P-1363), under 21 CFR 10.30, requesting that the Agency determine whether SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER (sodium chloride), injectable, 234 mg/mL, was 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 Sec. 314.161 that SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER (sodium chloride), injectable, 234 mg/mL, was not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER (sodium chloride), injectable, 234 mg/mL, was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER (sodium chloride), injectable, 234 mg/mL, 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 not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER (sodium chloride), injectable, 234 mg/mL, 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 this drug product 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: December 7, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-29674 Filed 12-9-16; 8:45 am] BILLING CODE 4164-01-P
![89470 Federal Register / Vol. 81, No. 238 / Monday, December 12, 2016 / Notices
requirements prior to the dispensing of of ‘‘Immediately in Effect Guidance SUPPLEMENTARY INFORMATION: In 1984,
certain hearing aid devices to Document: Conditions for Sale for Air- Congress enacted the Drug Price
individuals 18 years of age and older. Conduction Hearing Aids’’ may send an Competition and Patent Term
This guidance applies to the subset of email request to CDRH-Guidance@ Restoration Act of 1984 (Pub. L. 98–417)
hearing aids that are regulated as class fda.hhs.gov to receive an electronic (the 1984 amendments), which
I air-conduction hearing aids under copy of the document. Please use the authorized the approval of duplicate
§ 874.3300(b)(1) (21 CFR 874.3300(b)(1)) document number 16041 to identify the versions of drug products under an
and class II wireless air-conduction guidance you are requesting. ANDA procedure. ANDA applicants
hearing aids under § 874.3305, where must, with certain exceptions, show that
hearing aid means ‘‘any wearable IV. Paperwork Reduction Act of 1995
the drug for which they are seeking
instrument or device designed for, This guidance refers to previously approval contains the same active
offered for the purpose of, or approved collections of information ingredient in the same strength and
represented as aiding persons with or found in FDA regulations. These dosage form as the ‘‘listed drug,’’ which
compensating for, impaired hearing,’’ as collections of information are subject to is a version of the drug that was
defined in § 801.420(a)(1). This review by the Office of Management and previously approved. ANDA applicants
guidance does not apply to class II bone- Budget (OMB) under the Paperwork do not have to repeat the extensive
conduction hearing aids as identified in Reduction Act of 1995 (44 U.S.C. 3501– clinical testing otherwise necessary to
§ 874.3300(b)(2). Also, hearing aids 3520). The collections of information in gain approval of a new drug application
labeled for prescription use only, e.g., 21 CFR part 807, subpart E have been (NDA).
those that are inserted deep in the ear approved under OMB control number The 1984 amendments include what
canal by a hearing health professional, 0910–0120; and the collections of is now section 505(j)(7) of the Federal
should continue to be sold only as information in 21 CFR part 801 have Food, Drug, and Cosmetic Act (21 U.S.C.
directed. been approved under OMB control 355(j)(7)), which requires FDA to
This guidance is being implemented number 0910–0485. publish a list of all approved drugs.
without prior public comment because Dated: December 1, 2016. FDA publishes this list as part of the
the Agency has determined that prior Leslie Kux, ‘‘Approved Drug Products With
public participation is not feasible or Associate Commissioner for Policy. Therapeutic Equivalence Evaluations,’’
appropriate (see section 701(h)(1)(C)(i) which is known generally as the
[FR Doc. 2016–29724 Filed 12–9–16; 8:45 am]
of the FD&C Act (21 U.S.C. ‘‘Orange Book.’’ Under FDA regulations,
BILLING CODE 4164–01–P
371(h)(1)(C)(i)) and § 10.115.(g)(2) (21 drugs are removed from the list if the
CFR 10.115(g)(2))). FDA believes that Agency withdraws or suspends
immediate implementation of the DEPARTMENT OF HEALTH AND approval of the drug’s NDA or ANDA
guidance is needed to assist in HUMAN SERVICES for reasons of safety or effectiveness or
addressing a significant public health if FDA determines that the listed drug
issue. Further, FDA has determined that Food and Drug Administration was withdrawn from sale for reasons of
this guidance document presents a less safety or effectiveness (21 CFR 314.162).
burdensome policy that is consistent [Docket No. FDA–2016–P–1363] A person may petition the Agency to
with public health. Although this determine, or the Agency may
Determination That SODIUM
guidance is immediately in effect, FDA determine on its own initiative, whether
CHLORIDE 23.4% IN PLASTIC
will consider all comments received and a listed drug was withdrawn from sale
CONTAINER (Sodium Chloride),
revise the guidance document as for reasons of safety or effectiveness.
Injectable, 234 Milligrams/Milliliter,
appropriate. This determination may be made at any
Was Not Withdrawn From Sale for
time after the drug has been withdrawn
II. Significance of Guidance Reasons of Safety or Effectiveness
from sale, but must be made prior to
This guidance is being issued AGENCY: Food and Drug Administration, approving an ANDA that refers to the
consistent with FDA’s good guidance HHS. listed drug (§ 314.161 (21 CFR 314.161)).
practices regulation (§ 10.115). The ACTION: Notice. FDA may not approve an ANDA that
guidance represents the current thinking does not refer to a listed drug.
of FDA on conditions for sale for air- SUMMARY: The Food and Drug SODIUM CHLORIDE 23.4% IN
conduction hearing aids. It does not Administration (FDA or Agency) has PLASTIC CONTAINER (sodium
establish any rights for any person and determined that SODIUM CHLORIDE chloride), injectable, 234 mg/mL, is the
is not binding on FDA or the public. 23.4% IN PLASTIC CONTAINER subject of NDA 019329, held by Abraxis
You can use an alternative approach if (sodium chloride), injectable, 234 Pharmaceutical Products, and initially
it satisfies the requirements of the milligrams (mg)/milliliter (mL), was not approved on April 22, 1987. SODIUM
applicable statutes and regulations. withdrawn from sale for reasons of CHLORIDE 23.4% IN PLASTIC
safety or effectiveness. This CONTAINER is indicated for use in
III. Electronic Access determination will allow FDA to patients who have special problems of
Persons interested in obtaining a copy approve abbreviated new drug sodium electrolyte intake or excretion,
of the guidance may do so by applications (ANDAs) for sodium and for the treatment of sodium chloride
downloading an electronic copy from chloride, injectable, 234 mg/mL, if all and water deficiencies, which
the Internet. A search capability for all other legal and regulatory requirements commonly occur in many diseases.
Center for Devices and Radiological are met. In a letter dated January 18, 1996, the
mstockstill on DSK3G9T082PROD with NOTICES
Health guidance documents is available FOR FURTHER INFORMATION CONTACT: original NDA holder, Fujisawa USA,
at http://www.fda.gov/MedicalDevices/ David Faranda, Center for Drug Inc., notified FDA that SODIUM
DeviceRegulationandGuidance/ Evaluation and Research, Food and CHLORIDE 23.4% IN PLASTIC
GuidanceDocuments/default.htm. Drug Administration, 10903 New CONTAINER (sodium chloride),
Guidance documents are also available Hampshire Ave., Bldg. 51, Rm. 6213, injectable, 234 mg/mL, was being
at http://www.regulations.gov. Persons Silver Spring, MD 20993–0002, 301– discontinued, and FDA moved the drug
unable to download an electronic copy 796–8767. product to the ‘‘Discontinued Drug
VerDate Sep<11>2014 18:59 Dec 09, 2016 Jkt 241001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 E:\FR\FM\12DEN1.SGM 12DEN1](https://thefederalregister.org/doc/81_FR_89708/page/1.svg)
![Federal Register / Vol. 81, No. 238 / Monday, December 12, 2016 / Notices 89471
Product List’’ section of the Orange DEPARTMENT OF HEALTH AND which creates a compensation program.
Book. HUMAN SERVICES These sections are codified in the U.S.
Gordon Johnston Regulatory Code as 42 U.S.C. 247d–6d and 42
Office of the Secretary U.S.C. 247d–6e, respectively.
Consultants, LLC, submitted a citizen
The Pandemic and All-Hazards
petition dated May 25, 2016 (Docket No. Ebola Virus Disease Vaccines— Preparedness Reauthorization Act
FDA–2016–P–1363), under 21 CFR Amendment (PAHPRA), Public Law 113–5, was
10.30, requesting that the Agency enacted on March 13, 2013. Among
determine whether SODIUM CHLORIDE ACTION: Notice of Amendment to the
other things, PAHPRA added sections
23.4% IN PLASTIC CONTAINER December 3, 2014, Declaration under
564A and 564B to the Federal Food,
(sodium chloride), injectable, 234 mg/ the Public Readiness and Emergency
Drug, and Cosmetic (FD&C) Act to
mL, was withdrawn from sale for Preparedness Act for Ebola Virus
provide new authorities for the
reasons of safety or effectiveness. Disease Vaccines.
emergency use of approved products in
After considering the citizen petition SUMMARY: The Secretary is amending the emergencies and products held for
and reviewing Agency records and Declaration issued pursuant to section emergency use. PAHPRA accordingly
based on the information we have at this 319F–3 of the Public Health Service Act amended the definitions of ‘‘Covered
time, FDA has determined under on December 3, 2014 (79 FR 73314) and Countermeasures’’ and ‘‘qualified
§ 314.161 that SODIUM CHLORIDE amended on December 1, 2015 (80 FR pandemic and epidemic products’’ in
76541) to extend the effective time section 319F–3 of the Public Health
23.4% IN PLASTIC CONTAINER
period for an additional 24 months and Service Act (PREP Act provisions), so
(sodium chloride), injectable, 234 mg/
to clarify the description of Covered that products made available under
mL, was not withdrawn for reasons of these new FD&C Act authorities could
safety or effectiveness. The petitioner Countermeasures consistent with the
terms of the Declaration and be covered under PREP Act
has identified no data or other Declarations. PAHPRA also extended
republishing the Declaration in its
information suggesting that SODIUM the definition of qualified pandemic and
entirety as amended.
CHLORIDE 23.4% IN PLASTIC epidemic products that may be covered
DATES: The Amended Declaration is
CONTAINER (sodium chloride), under a PREP Act Declaration to include
effective as of December 3, 2016.
injectable, 234 mg/mL, was withdrawn products or technologies intended to
FOR FURTHER INFORMATION CONTACT:
for reasons of safety or effectiveness. We enhance the use or effect of a drug,
Nicole Lurie, MD, MSPH, Assistant
have carefully reviewed our files for biological product, or device used
Secretary for Preparedness and
records concerning the withdrawal of against the pandemic or epidemic or
Response, Office of the Secretary,
SODIUM CHLORIDE 23.4% IN against adverse events from these
Department of Health and Human products.
PLASTIC CONTAINER (sodium Services, 200 Independence Avenue
chloride), injectable, 234 mg/mL, from The Ebola virus causes an acute,
SW., Washington, DC 20201, Telephone serious illness that is often fatal. From
sale. We have also independently 202–205–2882.
evaluated relevant literature and data 2014 to 2015, West Africa experienced
SUPPLEMENTARY INFORMATION: The the largest and most complex Ebola
for possible postmarketing adverse Public Readiness and Emergency outbreak since the virus was discovered
events. We have reviewed the available Preparedness Act (PREP Act) authorizes in 1976, affecting populations in West
evidence and determined that this drug the Secretary of Health and Human African countries and travelers who left
product was not withdrawn from sale Services to issue a Declaration to West Africa. In 2014, the World Health
for reasons of safety or effectiveness. provide liability immunity to certain Organization (WHO) declared the Ebola
Accordingly, the Agency will individuals and entities (Covered Virus Disease Outbreak as a Public
continue to list SODIUM CHLORIDE Persons) against any claim of loss Health Emergency of International
23.4% IN PLASTIC CONTAINER caused by, arising out of, relating to, or Concern under the framework of the
(sodium chloride), injectable, 234 mg/ resulting from the administration or use International Health Regulations (2005).
mL, in the ‘‘Discontinued Drug Product of medical countermeasures (Covered In March 2016, WHO determined that
List’’ section of the Orange Book. The Countermeasures), except for claims the Ebola outbreak no longer constituted
‘‘Discontinued Drug Product List’’ that meet the PREP Act’s definition of a Public Health Emergency of
delineates, among other items, drug willful misconduct. The Secretary may, International Concern, but emphasized
products that have been discontinued through publication in the Federal the crucial need for continued support
Register, amend any portion of a to prevent, detect and respond rapidly
from marketing for reasons other than
Declaration. Using this authority, the to any new Ebola outbreak in West
safety or effectiveness. ANDAs that refer
Secretary is amending the Declaration Africa. Thus, there is a continuing need
to this drug product may be approved that provides liability immunity to
by the Agency as long as they meet all for development of vaccines against
Covered Persons for activities related to Ebola Virus Disease.
other legal and regulatory requirements the Covered Countermeasures, Ebola Unless otherwise noted, all statutory
for the approval of ANDAs. If FDA Virus Disease Vaccines listed in Section citations below are to the U.S. Code.
determines that labeling for this drug VI of the Declaration, to extend the
product should be revised to meet effective time period for an additional Section I, Determination of Public
current standards, the Agency will 24 months and to clarify the description Health Emergency or Credible Risk of
advise ANDA applicants to submit such of Covered Countermeasures consistent Future Public Health Emergency
mstockstill on DSK3G9T082PROD with NOTICES
labeling. with the terms of this Declaration. Before issuing a Declaration under the
Dated: December 7, 2016. The PREP Act was enacted on PREP Act, the Secretary is required to
December 30, 2005, as Public Law 109– determine that a disease or other health
Leslie Kux,
148, Division C, Section 2. It amended condition or threat to health constitutes
Associate Commissioner for Policy. the Public Health Service (PHS) Act, a public health emergency or that there
[FR Doc. 2016–29674 Filed 12–9–16; 8:45 am] adding section 319F–3, which addresses is a credible risk that the disease,
BILLING CODE 4164–01–P liability immunity, and section 319F–4, condition, or threat may constitute such
VerDate Sep<11>2014 18:59 Dec 09, 2016 Jkt 241001 PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 E:\FR\FM\12DEN1.SGM 12DEN1](https://thefederalregister.org/doc/81_FR_89708/page/2.svg)
Document Created: 2018-02-14 09:05:28
Document Modified: 2018-02-14 09:05:28
| 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. | |
| Contact | David Faranda, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6213, Silver Spring, MD 20993-0002, 301- 796-8767. | |
| FR Citation | 81 FR 89470 |
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