81 FR 89469 - Immediately in Effect Guidance Document: Conditions for Sale for Air-Conduction Hearing Aids; Guidance for Industry and Food and Drug Administration Staff; Availability
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 | 89469-89470 | |
| FR Document | 2016-29724 |
[Federal Register Volume 81, Number 238 (Monday, December 12, 2016)] [Notices] [Pages 89469-89470] From the Federal Register Online [www.thefederalregister.org] [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: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://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 http://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 http://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 http://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: http://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 http://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 http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at http://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 [email protected] 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
![Federal Register / Vol. 81, No. 238 / Monday, December 12, 2016 / Notices 89469
ways to minimize the burden of the solely responsible for ensuring that your copies to the Division of Dockets
collection of information on comment does not include any Management. If you do not wish your
respondents, including through the use confidential information that you or a name and contact information to be
of automated collection techniques or third party may not wish to be posted, made publicly available, you can
other forms of information technology. such as medical information, your or provide this information on the cover
Consideration will be given to anyone else’s Social Security number, or sheet and not in the body of your
comments and suggestions submitted confidential business information, such comments and you must identify this
within 60 days of this publication. as a manufacturing process. Please note information as ‘‘confidential.’’ Any
that if you include your name, contact information marked as ‘‘confidential’’
Mary Jones,
information, or other information that will not be disclosed except in
Reports Clearance Officer. identifies you in the body of your accordance with 21 CFR 10.20 and other
[FR Doc. 2016–29709 Filed 12–9–16; 8:45 am] comments, that information will be applicable disclosure law. For more
BILLING CODE 4184–32–P posted on http://www.regulations.gov. information about FDA’s posting of
• If you want to submit a comment comments to public dockets, see 80 FR
with confidential information that you 56469, September 18, 2015, or access
DEPARTMENT OF HEALTH AND do not wish to be made available to the the information at: http://www.fda.gov/
HUMAN SERVICES public, submit the comment as a regulatoryinformation/dockets/
written/paper submission and in the default.htm.
Food and Drug Administration manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
[Docket No. FDA–2016–D–3466] Submissions’’ and ‘‘Instructions’’). read background documents or the
Written/Paper Submissions electronic and written/paper comments
Immediately in Effect Guidance received, go to http://
Document: Conditions for Sale for Air- Submit written/paper submissions as www.regulations.gov and insert the
Conduction Hearing Aids; Guidance follows: docket number, found in brackets in the
for Industry and Food and Drug • Mail/Hand delivery/Courier (for
heading of this document, into the
Administration Staff; Availability written/paper submissions): Division of
‘‘Search’’ box and follow the prompts
Dockets Management (HFA–305), Food
AGENCY: Food and Drug Administration, and/or go to the Division of Dockets
and Drug Administration, 5630 Fishers
HHS. Management, 5630 Fishers Lane, Rm.
Lane, Rm. 1061, Rockville, MD 20852.
ACTION: Notice of availability. • For written/paper comments 1061, Rockville, MD 20852.
submitted to the Division of Dockets An electronic copy of the guidance
SUMMARY: The Food and Drug Management, FDA will post your document is available for download
Administration (FDA or Agency) is comment, as well as any attachments, from the Internet. See the
announcing the availability of the SUPPLEMENTARY INFORMATION section for
except for information submitted,
guidance entitled ‘‘Immediately in marked and identified, as confidential, information on electronic access to the
Effect Guidance Document: Conditions if submitted as detailed in guidance. Submit written requests for a
for Sale for Air-Conduction Hearing ‘‘Instructions.’’ single hard copy of the guidance
Aids.’’ FDA is issuing this guidance to Instructions: All submissions received document entitled ‘‘Immediately in
communicate to consumers, hearing aid must include the Docket No. FDA– Effect Guidance Document: Conditions
dispensers, hearing aid manufacturers, 2016–D–3466 for ‘‘Immediately in Effect for Sale for Air-Conduction Hearing
and hearing health professionals that Guidance Document: Conditions for Aids’’ to the Office of the Center
FDA does not intend to enforce certain Sale for Air-Conduction Hearing Aids.’’ Director, Guidance and Policy
conditions for sale of hearing aid Received comments will be placed in Development, Center for Devices and
devices that are required per FDA the docket and, except for those Radiological Health, Food and Drug
regulation. Specifically, FDA does not submitted as ‘‘Confidential Administration, 10903 New Hampshire
intend to enforce the medical evaluation Submissions,’’ publicly viewable at Ave., Bldg. 66, Rm. 5431, Silver Spring,
or recordkeeping requirements prior to http://www.regulations.gov or at the MD 20993–0002. Send one self-
the dispensing of certain hearing aid Division of Dockets Management addressed adhesive label to assist that
devices to individuals 18 years of age between 9 a.m. and 4 p.m., Monday office in processing your request.
and older. through Friday. FOR FURTHER INFORMATION CONTACT:
DATES: Submit either electronic or • Confidential Submissions—To Srinivas Nandkumar, Center for Devices
written comments on this guidance at submit a comment with confidential and Radiological Health, Food and Drug
any time. General comments on Agency information that you do not wish to be Administration, 10903 New Hampshire
guidance documents are welcome at any made publicly available, submit your Ave., Bldg. 66, Rm. 2436, Silver Spring,
time. comments only as a written/paper MD 20993–0002, 301–796–6480.
ADDRESSES: You may submit comments submission. You should submit two SUPPLEMENTARY INFORMATION:
as follows: copies total. One copy will include the
information you claim to be confidential I. Background
Electronic Submissions with a heading or cover note that states FDA is issuing this guidance to
Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS communicate to consumers, hearing aid
following way: CONFIDENTIAL INFORMATION.’’ The dispensers, hearing aid manufacturers,
• Federal eRulemaking Portal: http:// Agency will review this copy, including and hearing health professionals that
mstockstill on DSK3G9T082PROD with NOTICES
www.regulations.gov. Follow the the claimed confidential information, in FDA does not intend to enforce certain
instructions for submitting comments. its consideration of comments. The conditions for sale of hearing aid
Comments submitted electronically, second copy, which will have the devices that are required per FDA
including attachments, to http:// claimed confidential information regulation. Specifically, FDA does not
www.regulations.gov will be posted to redacted/blacked out, will be available intend to enforce the medical evaluation
the docket unchanged. Because your for public viewing and posted on http:// (§ 801.421(a) (21 CFR 801.421(a)) or
comment will be made public, you are www.regulations.gov. Submit both recordkeeping (§ 801.421(d))
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![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_89707/page/2.svg)
Document Created: 2018-02-14 09:05:36
Document Modified: 2018-02-14 09:05:36
| 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 of availability. | |
| Dates | Submit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome at any time. | |
| 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. | |
| FR Citation | 81 FR 89469 |
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