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
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