Immediately in Effect Guidance Document: Conditions for Sale for Air-Conduction Hearing Aids; Guidance for Industry and Food and Drug Administration Staff; Availability, 89469-89470 [2016-29724]
Download as PDF
Federal Register / Vol. 81, No. 238 / Monday, December 12, 2016 / Notices
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Mary Jones,
Reports Clearance Officer.
[FR Doc. 2016–29709 Filed 12–9–16; 8:45 am]
BILLING CODE 4184–32–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–D–3466]
Immediately in Effect Guidance
Document: Conditions for Sale for AirConduction Hearing Aids; Guidance
for Industry and Food and Drug
Administration Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of the
guidance entitled ‘‘Immediately in
Effect Guidance Document: Conditions
for Sale for Air-Conduction Hearing
Aids.’’ FDA is issuing this guidance to
communicate to consumers, hearing aid
dispensers, hearing aid manufacturers,
and hearing health professionals that
FDA does not intend to enforce certain
conditions for sale of hearing aid
devices that are required per FDA
regulation. Specifically, FDA does not
intend to enforce the medical evaluation
or recordkeeping requirements prior to
the dispensing of certain hearing aid
devices to individuals 18 years of age
and older.
DATES: Submit either electronic or
written comments on this guidance at
any time. General comments on Agency
guidance documents are welcome at any
time.
ADDRESSES: You may submit comments
as follows:
SUMMARY:
mstockstill on DSK3G9T082PROD with NOTICES
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
VerDate Sep<11>2014
18:59 Dec 09, 2016
Jkt 241001
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): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, 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–
2016–D–3466 for ‘‘Immediately in Effect
Guidance Document: Conditions for
Sale for Air-Conduction Hearing Aids.’’
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
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
redacted/blacked out, will be available
for public viewing and posted on https://
www.regulations.gov. Submit both
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
89469
copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
An electronic copy of the guidance
document is available for download
from the Internet. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance. Submit written requests for a
single hard copy of the guidance
document entitled ‘‘Immediately in
Effect Guidance Document: Conditions
for Sale for Air-Conduction Hearing
Aids’’ to the Office of the Center
Director, Guidance and Policy
Development, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, Silver Spring,
MD 20993–0002. Send one selfaddressed adhesive label to assist that
office in processing your request.
FOR FURTHER INFORMATION CONTACT:
Srinivas Nandkumar, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2436, Silver Spring,
MD 20993–0002, 301–796–6480.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is issuing this guidance to
communicate to consumers, hearing aid
dispensers, hearing aid manufacturers,
and hearing health professionals that
FDA does not intend to enforce certain
conditions for sale of hearing aid
devices that are required per FDA
regulation. Specifically, FDA does not
intend to enforce the medical evaluation
(§ 801.421(a) (21 CFR 801.421(a)) or
recordkeeping (§ 801.421(d))
E:\FR\FM\12DEN1.SGM
12DEN1
89470
Federal Register / Vol. 81, No. 238 / Monday, December 12, 2016 / Notices
requirements prior to the dispensing of
certain hearing aid devices to
individuals 18 years of age and older.
This guidance applies to the subset of
hearing aids that are regulated as class
I air-conduction hearing aids under
§ 874.3300(b)(1) (21 CFR 874.3300(b)(1))
and class II wireless air-conduction
hearing aids under § 874.3305, where
hearing aid means ‘‘any wearable
instrument or device designed for,
offered for the purpose of, or
represented as aiding persons with or
compensating for, impaired hearing,’’ as
defined in § 801.420(a)(1). This
guidance does not apply to class II boneconduction hearing aids as identified in
§ 874.3300(b)(2). Also, hearing aids
labeled for prescription use only, e.g.,
those that are inserted deep in the ear
canal by a hearing health professional,
should continue to be sold only as
directed.
This guidance is being implemented
without prior public comment because
the Agency has determined that prior
public participation is not feasible or
appropriate (see section 701(h)(1)(C)(i)
of the FD&C Act (21 U.S.C.
371(h)(1)(C)(i)) and § 10.115.(g)(2) (21
CFR 10.115(g)(2))). FDA believes that
immediate implementation of the
guidance is needed to assist in
addressing a significant public health
issue. Further, FDA has determined that
this guidance document presents a less
burdensome policy that is consistent
with public health. Although this
guidance is immediately in effect, FDA
will consider all comments received and
revise the guidance document as
appropriate.
mstockstill on DSK3G9T082PROD with NOTICES
II. Significance of Guidance
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (§ 10.115). The
guidance represents the current thinking
of FDA on conditions for sale for airconduction hearing aids. It does not
establish any rights for any person and
is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
III. Electronic Access
Persons interested in obtaining a copy
of the guidance may do so by
downloading an electronic copy from
the Internet. A search capability for all
Center for Devices and Radiological
Health guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://www.regulations.gov. Persons
unable to download an electronic copy
VerDate Sep<11>2014
18:59 Dec 09, 2016
Jkt 241001
of ‘‘Immediately in Effect Guidance
Document: Conditions for Sale for AirConduction Hearing Aids’’ may send an
email request to CDRH-Guidance@
fda.hhs.gov to receive an electronic
copy of the document. Please use the
document number 16041 to identify the
guidance you are requesting.
IV. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
21 CFR part 807, subpart E have been
approved under OMB control number
0910–0120; and the collections of
information in 21 CFR part 801 have
been approved under OMB control
number 0910–0485.
Dated: December 1, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–29724 Filed 12–9–16; 8:45 am]
BILLING CODE 4164–01–P
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.
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.
SUMMARY:
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
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 (§ 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
SUPPLEMENTARY INFORMATION:
E:\FR\FM\12DEN1.SGM
12DEN1
Agencies
[Federal Register Volume 81, Number 238 (Monday, December 12, 2016)]
[Notices]
[Pages 89469-89470]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-29724]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-D-3466]
Immediately in Effect Guidance Document: Conditions for Sale for
Air-Conduction Hearing Aids; Guidance for Industry and Food and Drug
Administration Staff; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the guidance entitled ``Immediately in Effect
Guidance Document: Conditions for Sale for Air-Conduction Hearing
Aids.'' FDA is issuing this guidance to communicate to consumers,
hearing aid dispensers, hearing aid manufacturers, and hearing health
professionals that FDA does not intend to enforce certain conditions
for sale of hearing aid devices that are required per FDA regulation.
Specifically, FDA does not intend to enforce the medical evaluation or
recordkeeping requirements prior to the dispensing of certain hearing
aid devices to individuals 18 years of age and older.
DATES: Submit either electronic or written comments on this guidance at
any time. General comments on Agency guidance documents are welcome at
any time.
ADDRESSES: 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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, 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-2016-D-3466 for ``Immediately in Effect Guidance Document:
Conditions for Sale for Air-Conduction Hearing Aids.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management 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 redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
An electronic copy of the guidance document is available for
download from the Internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Immediately in Effect Guidance Document: Conditions for Sale for Air-
Conduction Hearing Aids'' to the Office of the Center Director,
Guidance and Policy Development, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-addressed
adhesive label to assist that office in processing your request.
FOR FURTHER INFORMATION CONTACT: Srinivas Nandkumar, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 2436, Silver Spring, MD 20993-0002, 301-
796-6480.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is issuing this guidance to communicate to consumers, hearing
aid dispensers, hearing aid manufacturers, and hearing health
professionals that FDA does not intend to enforce certain conditions
for sale of hearing aid devices that are required per FDA regulation.
Specifically, FDA does not intend to enforce the medical evaluation
(Sec. 801.421(a) (21 CFR 801.421(a)) or recordkeeping (Sec.
801.421(d))
[[Page 89470]]
requirements prior to the dispensing of certain hearing aid devices to
individuals 18 years of age and older.
This guidance applies to the subset of hearing aids that are
regulated as class I air-conduction hearing aids under Sec.
874.3300(b)(1) (21 CFR 874.3300(b)(1)) and class II wireless air-
conduction hearing aids under Sec. 874.3305, where hearing aid means
``any wearable instrument or device designed for, offered for the
purpose of, or represented as aiding persons with or compensating for,
impaired hearing,'' as defined in Sec. 801.420(a)(1). This guidance
does not apply to class II bone-conduction hearing aids as identified
in Sec. 874.3300(b)(2). Also, hearing aids labeled for prescription
use only, e.g., those that are inserted deep in the ear canal by a
hearing health professional, should continue to be sold only as
directed.
This guidance is being implemented without prior public comment
because the Agency has determined that prior public participation is
not feasible or appropriate (see section 701(h)(1)(C)(i) of the FD&C
Act (21 U.S.C. 371(h)(1)(C)(i)) and Sec. 10.115.(g)(2) (21 CFR
10.115(g)(2))). FDA believes that immediate implementation of the
guidance is needed to assist in addressing a significant public health
issue. Further, FDA has determined that this guidance document presents
a less burdensome policy that is consistent with public health.
Although this guidance is immediately in effect, FDA will consider all
comments received and revise the guidance document as appropriate.
II. Significance of Guidance
This guidance is being issued consistent with FDA's good guidance
practices regulation (Sec. 10.115). The guidance represents the
current thinking of FDA on conditions for sale for air-conduction
hearing aids. It does not establish any rights for any person and is
not binding on FDA or the public. You can use an alternative approach
if it satisfies the requirements of the applicable statutes and
regulations.
III. Electronic Access
Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the Internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at https://www.regulations.gov. Persons
unable to download an electronic copy of ``Immediately in Effect
Guidance Document: Conditions for Sale for Air-Conduction Hearing
Aids'' may send an email request to CDRH-Guidance@fda.hhs.gov to
receive an electronic copy of the document. Please use the document
number 16041 to identify the guidance you are requesting.
IV. Paperwork Reduction Act of 1995
This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 807, subpart E have been
approved under OMB control number 0910-0120; and the collections of
information in 21 CFR part 801 have been approved under OMB control
number 0910-0485.
Dated: December 1, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-29724 Filed 12-9-16; 8:45 am]
BILLING CODE 4164-01-P