83 FR 21297 - Waivers, Exceptions, and Exemptions From the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 90 (May 9, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 90 (May 9, 2018)
| Page Range | 21297-21299 | |
| FR Document | 2018-09843 |
[Federal Register Volume 83, Number 90 (Wednesday, May 9, 2018)] [Notices] [Pages 21297-21299] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-09843] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-D-1434] Waivers, Exceptions, and Exemptions From the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act.'' When finalized, this draft guidance will describe the process that trading partners and stakeholders should use to request a waiver, exception, or exemption from certain requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act), and describe how FDA intends to review and decide such requests and determine FDA-initiated exceptions and exemptions. Additionally, when finalized, this draft guidance will describe how FDA intends to biennially review and renew waivers, exceptions, and exemptions. DATES: Submit either electronic or written comments on the draft guidance by July 9, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time 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): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, 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-2018-D-1434 for ``Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry.'' 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 Dockets Management Staff 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 [[Page 21298]] 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 Dockets Management Staff. 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.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. 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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002, or the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Abha Kundi, Office of Compliance, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-3130, [email protected]. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ``Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act.'' The Drug Supply Chain Security Act (DSCSA) was signed into law on November 27, 2013 (Title II of Pub. L. 113-54). The DSCSA outlines critical steps to build an electronic, interoperable system by 2023 that can identify and trace products as they are distributed in the United States. Section 202 of the DSCSA added section 582 to the FD&C Act (21 U.S.C. 360eee- 1), which sets forth trading partner requirements, including those related to product tracing, product identifiers, authorized trading partners, and verification. Section 582(a)(3)(A) of the FD&C Act directs FDA to establish processes by which: (1) An authorized trading partner (i.e., manufacturer, repackager, wholesale distributor, or dispenser) may request a waiver from certain requirements in section 582 if it would result in an undue economic hardship or for emergency medical reasons; (2) a manufacturer or repackager may request an exception to the section 582 requirements related to product identifiers if a product package is too small or otherwise unable to accommodate a label with sufficient space; and (3) FDA may determine other products or transactions shall be exempt from certain requirements in section 582. Accordingly, this draft guidance describes these processes required by the law. Additionally, as required by section 582(a)(3)(B) of the FD&C Act, this draft guidance also includes a process for the biennial review and renewal of waivers, exceptions, and exemptions. This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on the process for waivers, exceptions, and exemptions from the requirements of section 582 of the FD&C Act. 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. This guidance is not subject to Executive Order 12866. II. Paperwork Reduction Act of 1995 Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501- 3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. III. Waivers, Exceptions, and Exemptions From the Requirements of Section 582 of the FD&C Act Under the draft guidance, a trading partner or stakeholder may request a waiver, exception, or exemption from the requirements of section 582 of the FD&C Act. FDA estimates that annually a total of approximately 20 waiver, exception, or exemption requests will be submitted to the Agency by approximately 20 trading partners or stakeholders. This estimate is based on communications the Agency has had with trading partners and stakeholders since the enactment of the DSCSA in 2013. FDA also estimates that it will take respondents an average of 40 hours to prepare and submit each request, including the time to submit any additional followup information that may be requested by FDA. FDA estimates that the total annual burden hours for submitting these requests are [[Page 21299]] approximately 800 hours (see table 1, row 1). Under the draft guidance, a recipient of a waiver, exception, or exemption should notify FDA whenever there is a material change in the circumstances that were the basis for the relief. In addition, FDA intends to biennially review waivers, exceptions, and exemptions that are longer than 2 years in duration as described in the draft guidance, and may ask the recipients to submit information to determine whether there has been a material change in the circumstances. FDA estimates that annually it will receive approximately 1 notification or other information from approximately 1 respondent that there has or has not been a material change in the circumstances that warranted the waiver, exception, or exemption, and that each notification will take approximately 16 hours to prepare and submit to FDA. We estimate that the total annual burden hours for submitting this information to FDA are approximately 16 hours (see table 1, row 2). Under the draft guidance, a trading partner may request that FDA renew a waiver, exception, or exemption that is of limited duration. This request should include a detailed statement justifying the continuance of the relief and the desired length of the extension. FDA estimates that annually it will receive approximately 1 renewal request from approximately 1 respondent, and that each request will take approximately 16 hours to prepare and submit to FDA. We estimate that the total annual burden hours for submitting these requests to FDA are approximately 16 hours (see table 1, row 3). Table 1--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Waivers, Exceptions, and Number of Exemptions from section 582 of Number of responses per Total annual Average burden Total hours the FD&C Act--Draft Guidance respondents respondent responses per response ---------------------------------------------------------------------------------------------------------------- Requests to FDA for a Waiver, 20 1 20 40 800 Exception, or Exemption........ Notification to FDA of a 1 1 1 16 16 Material Change in Circumstances Warranting the Waiver, Exception, or Exemption Requests to FDA to Renew a 1 1 1 16 16 Waiver, Exception, or Exemption ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 832 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. III. Electronic Access Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or https://www.regulations.gov. Dated: May 3, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-09843 Filed 5-8-18; 8:45 am] BILLING CODE 4164-01-P
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To obtain copies of a supporting collect information on patient ADDRESSES: You may submit comments
statement and any related forms for the satisfaction, HCAHPS created a national on any guidance at any time as follows:
proposed collection(s) summarized in standard for the collection and public
Electronic Submissions
this notice, you may make your request reporting of information that enables
using one of following: valid comparisons to be made across all Submit electronic comments in the
1. Access CMS’ website address at hospitals to support consumer choice. following way:
https://www.cms.gov/Regulations-and- Form Number: CMS–10102 (OMB • Federal eRulemaking Portal:
Guidance/Legislation/ control number 0938–0981); Frequency: https://www.regulations.gov. Follow the
PaperworkReductionActof1995/PRA- Occasionally; Affected Public: Private instructions for submitting comments.
Listing.html. sector (Business or other for-profits and Comments submitted electronically,
2. Email your request, including your Not-for-profit institutions); Number of including attachments, to https://
address, phone number, OMB number, Respondents: 4,200; Total Annual www.regulations.gov will be posted to
and CMS document identifier, to Responses: 3,100,000; Total Annual the docket unchanged. Because your
Paperwork@cms.hhs.gov. Hours: 413,230. (For policy questions comment will be made public, you are
3. Call the Reports Clearance Office at regarding this collection contact solely responsible for ensuring that your
(410) 786–1326. William Lehrman at 410–786–1037.) comment does not include any
FOR FURTHER INFORMATION CONTACT: confidential information that you or a
Dated: May 2, 2018.
William Parham at (410) 786–4669. third party may not wish to be posted,
William N. Parham, III, such as medical information, your or
SUPPLEMENTARY INFORMATION:
Director, Paperwork Reduction Staff, Office anyone else’s Social Security number, or
Contents of Strategic Operations and Regulatory confidential business information, such
This notice sets out a summary of the Affairs.
as a manufacturing process. Please note
use and burden associated with the [FR Doc. 2018–09686 Filed 5–8–18; 8:45 am] that if you include your name, contact
following information collections. More BILLING CODE 4120–01–P information, or other information that
detailed information can be found in identifies you in the body of your
each collection’s supporting statement comments, that information will be
and associated materials (see DEPARTMENT OF HEALTH AND posted on https://www.regulations.gov.
ADDRESSES). HUMAN SERVICES • If you want to submit a comment
CMS–10102 National Implementation with confidential information that you
Food and Drug Administration
of the Hospital CAHPS Survey do not wish to be made available to the
[Docket No. FDA–2018–D–1434] public, submit the comment as a
Under the PRA (44 U.S.C. 3501– written/paper submission and in the
3520), federal agencies must obtain Waivers, Exceptions, and Exemptions manner detailed (see ‘‘Written/Paper
approval from the Office of Management From the Requirements of Section 582 Submissions’’ and ‘‘Instructions’’).
and Budget (OMB) for each collection of of the Federal Food, Drug, and
information they conduct or sponsor. Cosmetic Act; Draft Guidance for Written/Paper Submissions
The term ‘‘collection of information’’ is Industry; Availability Submit written/paper submissions as
defined in 44 U.S.C. 3502(3) and 5 CFR follows:
1320.3(c) and includes agency requests AGENCY: Food and Drug Administration, • Mail/Hand delivery/Courier (for
or requirements that members of the HHS. written/paper submissions): Dockets
public submit reports, keep records, or ACTION: Notice of availability. Management Staff (HFA–305), Food and
provide information to a third party. Drug Administration, 5630 Fishers
Section 3506(c)(2)(A) of the PRA SUMMARY: The Food and Drug Lane, Rm. 1061, Rockville, MD 20852.
requires federal agencies to publish a Administration (FDA or Agency) is • For written/paper comments
60-day notice in the Federal Register announcing the availability of a draft submitted to the Dockets Management
concerning each proposed collection of guidance for industry entitled ‘‘Waivers, Staff, FDA will post your comment, as
information, including each proposed Exceptions, and Exemptions from the well as any attachments, except for
extension or reinstatement of an existing Requirements of Section 582 of the information submitted, marked and
collection of information, before Federal Food, Drug, and Cosmetic Act.’’ identified, as confidential, if submitted
submitting the collection to OMB for When finalized, this draft guidance will as detailed in ‘‘Instructions.’’
approval. To comply with this describe the process that trading Instructions: All submissions received
requirement, CMS is publishing this partners and stakeholders should use to must include the Docket No. FDA–
notice. request a waiver, exception, or 2018–D–1434 for ‘‘Waivers, Exceptions,
exemption from certain requirements of and Exemptions from the Requirements
Information Collection the Federal Food, Drug, and Cosmetic of Section 582 of the Federal Food,
1. Type of Information Collection Act (FD&C Act), and describe how FDA Drug, and Cosmetic Act; Draft Guidance
Request: Extension of a currently intends to review and decide such for Industry.’’ Received comments will
approved collection; Title of requests and determine FDA-initiated be placed in the docket and, except for
Information Collection: National exceptions and exemptions. those submitted as ‘‘Confidential
Implementation of the Hospital CAHPS Additionally, when finalized, this draft Submissions,’’ publicly viewable at
Survey; Use: The HCAHPS (Hospital guidance will describe how FDA https://www.regulations.gov or at the
Consumer Assessment of Healthcare intends to biennially review and renew Dockets Management Staff between 9
amozie on DSK3GDR082PROD with NOTICES
Providers and Systems) Survey, also waivers, exceptions, and exemptions. a.m. and 4 p.m., Monday through
known as the CAHPS® Hospital Survey DATES: Submit either electronic or Friday.
or Hospital CAHPS®, is a standardized written comments on the draft guidance • Confidential Submissions—To
survey instrument and data collection by July 9, 2018 to ensure that the submit a comment with confidential
methodology that has been in use since Agency considers your comment on this information that you do not wish to be
2006 to measure patients’ perspectives draft guidance before it begins work on made publicly available, submit your
of hospital care. While many hospitals the final version of the guidance. comments only as a written/paper
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![Federal Register / Vol. 83, No. 90 / Wednesday, May 9, 2018 / Notices 21299
approximately 800 hours (see table 1, FDA estimates that annually it will waiver, exception, or exemption that is
row 1). receive approximately 1 notification or of limited duration. This request should
Under the draft guidance, a recipient other information from approximately 1 include a detailed statement justifying
of a waiver, exception, or exemption respondent that there has or has not the continuance of the relief and the
been a material change in the desired length of the extension. FDA
should notify FDA whenever there is a
circumstances that warranted the estimates that annually it will receive
material change in the circumstances
waiver, exception, or exemption, and approximately 1 renewal request from
that were the basis for the relief. In that each notification will take
addition, FDA intends to biennially approximately 1 respondent, and that
approximately 16 hours to prepare and each request will take approximately 16
review waivers, exceptions, and submit to FDA. We estimate that the
exemptions that are longer than 2 years hours to prepare and submit to FDA. We
total annual burden hours for
in duration as described in the draft estimate that the total annual burden
submitting this information to FDA are
guidance, and may ask the recipients to hours for submitting these requests to
approximately 16 hours (see table 1, row
submit information to determine FDA are approximately 16 hours (see
2).
whether there has been a material Under the draft guidance, a trading table 1, row 3).
change in the circumstances. partner may request that FDA renew a
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Waivers, Exceptions, and Exemptions from section 582 of Number of Total annual
responses per burden per Total hours
the FD&C Act—Draft Guidance respondents responses
respondent response
Requests to FDA for a Waiver, Exception, or Exemption ... 20 1 20 40 800
Notification to FDA of a Material Change in Circumstances
Warranting the Waiver, Exception, or Exemption ............ 1 1 1 16 16
Requests to FDA to Renew a Waiver, Exception, or Ex-
emption ............................................................................. 1 1 1 16 16
Total .............................................................................. ........................ ........................ ........................ ........................ 832
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
III. Electronic Access notice announces that the National related to current focus areas of the
Persons with access to the internet Advisory Council of the National Health NHSC. Information about the
may obtain the draft guidance at either Service Corps (NACNHSC) will hold a NACNHSC, a roster of members, the
https://www.fda.gov/Drugs/ public meeting. meeting agenda, as well as past meeting
GuidanceCompliance DATES: Tuesday, May 15, 2018, 2:00 summaries is located on the NACNHSC
RegulatoryInformation/Guidances/ p.m. to 5:30 p.m. ET. website: https://nhsc.hrsa.gov/
default.htm, https://www.fda.gov/ ADDRESSES: The meeting is a corpsexperience/aboutus/
BiologicsBloodVaccines/ teleconference and webinar. The nationaladvisorycouncil/.
GuidanceCompliance conference call-in number is 1–800– Public Participation: Members of the
RegulatoryInformation/Guidances/ 619–2521; passcode: 9271697. The public and interested parties may
default.htm, or https:// webinar link is https:// request to participate in the meeting or
www.regulations.gov. hrsa.connectsolutions.com/nacnhsc. provide oral public comment during the
Dated: May 3, 2018. FOR FURTHER INFORMATION CONTACT: meeting by contacting Monica-Tia
Leslie Kux, Diane Fabiyi-King, Designated Federal Bullock via email at MBullock@hrsa.gov
Associate Commissioner for Policy. Official (DFO), Division of National by May 10, 2018. Public comment will
[FR Doc. 2018–09843 Filed 5–8–18; 8:45 am]
Health Service Corps (NHSC), Bureau of be limited to three (3) minutes per
Health Workforce (BHW), HRSA. speaker.
BILLING CODE 4164–01–P
Address: 5600 Fishers Lane, Room
14N110, Rockville, Maryland 20857; Public participants may also submit
phone: (301) 443–3609; or email: written statements in advance of the
DEPARTMENT OF HEALTH AND
DFabiyi-King@hrsa.gov. scheduled meeting. Written statements
HUMAN SERVICES
SUPPLEMENTARY INFORMATION:
are due to Monica-Tia Bullock at
Health Resources and Service Background: NACNHSC consults, MBullock@hrsa.gov by May 10, 2018.
Administration advises, and makes recommendations to Please be advised that committee
the Secretary of HHS and HRSA’s members will receive copies of all
National Advisory Council on the Administrator, with respect to their written statements submitted from the
National Health Service Corps; Notice responsibilities under Subpart II, Part D public. Any further public participation
of Meeting of Title III of the Public Health Service will be at the sole discretion of the
AGENCY: Health Resources and Service Act, as amended (NHSC and Health Chair, with approval from the DFO.
amozie on DSK3GDR082PROD with NOTICES
Administration (HRSA), Department of Professional Shortage Area
Amy P. McNulty,
Health and Human Services (HHS). Designations). The NACNHSC also
reviews and comments on regulations Acting Director, Division of the Executive
ACTION: Notice of Advisory Committee Secretariat.
meeting. promulgated by the Secretary under
Subpart II. [FR Doc. 2018–09825 Filed 5–8–18; 8:45 am]
SUMMARY: In accordance with the Agenda: During the May 15, 2018, BILLING CODE 4165–15–P
Federal Advisory Committee Act, this meeting, NACNHSC will discuss issues
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Document Created: 2018-05-09 03:17:29
Document Modified: 2018-05-09 03:17:29
| 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 the draft guidance by July 9, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. | |
| Contact | Abha Kundi, Office of Compliance, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-3130, [email protected]gov. | |
| FR Citation | 83 FR 21297 |
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