83 FR 34142 - Field Alert Report Submission: Questions and Answers; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 139 (July 19, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 139 (July 19, 2018)
| Page Range | 34142-34143 | |
| FR Document | 2018-15389 |
[Federal Register Volume 83, Number 139 (Thursday, July 19, 2018)] [Notices] [Pages 34142-34143] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-15389] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-D-2326] Field Alert Report Submission: Questions and Answers; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Field Alert Report Submission: Questions and Answers.'' This draft guidance, when finalized, will provide the Agency's current thinking regarding the requirements for submission of field alert reports (FARs) by applicants of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) and will outline FDA's recommendations for FAR submissions to help increase their consistency and relevancy. The draft guidance also addresses certain frequently asked questions about FARs. DATES: Submit either electronic or written comments on the draft guidance by September 17, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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 [[Page 34143]] 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-2326 for ``Field Alert Report Submission: Questions and Answers; 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 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 to 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: Mamta Gautam-Basak, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 21, Rm. 2508, Silver Spring, MD 20993-0002, 301- 796-0712; Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911; or Rachel Harrington, Office of Regulatory Affairs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 4339, Silver Spring, MD 20993-0002, 410- 779-5441. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ``Field Alert Report Submission: Questions and Answers.'' The FAR regulations found in 21 CFR 314.81(b)(1) and 314.98(b) establish an early warning system to help protect patient health. Under these regulations, NDA and ANDA applicants must submit certain information to FDA about distributed drug products regulated by the Center for Drug Evaluation and Research or the Center for Biologics Evaluation and Research. The draft guidance addresses the FAR submission requirements and focuses on topics such as the incidents and possible/actual quality issues that require submission of a FAR, the contents of the FAR, who submits the FAR, and when, where, and how they should submit it. The draft guidance also addresses followup and final FARs, which are not required under Sec. 314.81(b), and recommends their submission to inform FDA of the status of root cause investigations and corrective actions taken, if any. 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 field alert report submissions. 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 The draft guidance refers to previously approved collections of information that 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 314 have been approved under OMB control number 0910-0001. III. Electronic Access Persons with access to the internet may obtain the draft guidance at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or https://www.regulations.gov. Dated: July 13, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-15389 Filed 7-18-18; 8:45 am] BILLING CODE 4164-01-P
![34142 Federal Register / Vol. 83, No. 139 / Thursday, July 19, 2018 / Notices
proposed biological product that is You can use an alternative approach if DEPARTMENT OF HEALTH AND
demonstrated to be biosimilar to a it satisfies the requirements of the HUMAN SERVICES
reference product can rely on certain applicable statutes and regulations. This
existing scientific knowledge about the guidance is not subject to Executive Food and Drug Administration
safety, purity, and potency of the Order 12866. [Docket No. FDA–2018–D–2326]
reference product to support licensure,
and this is reflected in the approach to II. Paperwork Reduction Act of 1995 Field Alert Report Submission:
biosimilar product labeling. Questions and Answers; Draft
In this guidance, FDA outlines its This guidance refers to previously
approved collections of information Guidance for Industry; Availability
recommendations for biosimilar product
labeling. A demonstration of found in FDA regulations. These AGENCY: Food and Drug Administration,
biosimilarity means, among other collections of information are subject to HHS.
things, that FDA has determined that review by the Office of Management and ACTION: Notice of availability.
there are no clinically meaningful Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501– SUMMARY: The Food and Drug
differences between the proposed
3520). The collections of information for Administration (FDA or Agency) is
product and the reference product in
terms of safety, purity, and potency. announcing the availability of a draft
the submission of a biologics license
Accordingly, biosimilar applicants guidance for industry entitled ‘‘Field
application under section 351(k) of the
should incorporate relevant data and Alert Report Submission: Questions and
PHS Act have been approved under
information from the reference product Answers.’’ This draft guidance, when
OMB control number 0910–0719; the finalized, will provide the Agency’s
labeling, with appropriate modifications collections of information in 21 CFR
as recommended in the guidance. current thinking regarding the
201.56 and 201.57 for the submission of requirements for submission of field
This guidance finalizes the draft labeling have been approved under
guidance issued on April 4, 2016. alert reports (FARs) by applicants of
OMB control number 0910–0572; the new drug applications (NDAs) and
Changes made to the guidance took into
collections of information in 21 CFR abbreviated new drug applications
consideration the comments received, as
part 208 for Medication Guides have (ANDAs) and will outline FDA’s
well as requests regarding the
requirements for and/or contents of been approved under OMB control recommendations for FAR submissions
biosimilar labeling made in the number 0910–0393; the collections of to help increase their consistency and
following citizen petitions: FDA–2015– information in 21 CFR 312.47 for relevancy. The draft guidance also
P–2000 (submitted by AbbVie, Inc.), meetings with FDA have been approved addresses certain frequently asked
FDA–2015–P–4529 (submitted by a under OMB control number 0910–0014; questions about FARs.
group of institutional investors the collections of information in 21 CFR DATES: Submit either electronic or
including the United Auto Workers part 600 for the submission of adverse written comments on the draft guidance
(UAW) Retiree Medical Benefits Trust), experience reporting for licensed by September 17, 2018 to ensure that
and FDA–2015–P–0776 (submitted by biological products and general records the Agency considers your comment on
the Pharmaceutical Research and have been approved under OMB control this draft guidance before it begins work
Manufacturers of America and the number 0910–0308; and the collections on the final version of the guidance.
Biotechnology Industry Organization) of information in 21 CFR part 601 for ADDRESSES: You may submit comments
(these citizen petitions are available at the submission of labeling in a biologics on any guidance at any time as follows:
https://www.regulations.gov). Editorial license application or supplement to a
changes were made primarily for Electronic Submissions
biologics license application have been
clarification. approved under OMB control number Submit electronic comments in the
In the Federal Register of April 4, 0910–0338. following way:
2016 (81 FR 19194), FDA announced the • Federal eRulemaking Portal:
availability of the draft guidance for III. Electronic Access https://www.regulations.gov. Follow the
industry ‘‘Labeling for Biosimilar instructions for submitting comments.
Products.’’ FDA requested comment on Persons with access to the internet Comments submitted electronically,
whether FDA-approved patient labeling may obtain the guidance at https:// including attachments, to https://
(e.g., Patient Information, Medication www.fda.gov/Drugs/Guidance www.regulations.gov will be posted to
Guide, and Instructions for Use) should ComplianceRegulatoryInformation/ the docket unchanged. Because your
include a biosimilarity statement similar Guidances/default.htm, https:// comment will be made public, you are
to the statement described in section www.fda.gov/BiologicsBloodVaccines/ solely responsible for ensuring that your
IV.C.1 of the draft guidance. Several GuidanceComplianceRegulatory comment does not include any
comments agreed with inclusion of the Information/Guidances/default.htm, or confidential information that you or a
biosimilarity statement; one comment https://www.regulations.gov. third party may not wish to be posted,
disagreed. FDA considered the such as medical information, your or
Dated: July 13, 2018.
comments received, but decided not to anyone else’s Social Security number, or
recommend inclusion of a biosimilarity Leslie Kux, confidential business information, such
statement in FDA-approved patient Associate Commissioner for Policy. as a manufacturing process. Please note
labeling at this time. [FR Doc. 2018–15391 Filed 7–18–18; 8:45 am] that if you include your name, contact
This guidance is being issued
sradovich on DSK3GMQ082PROD with NOTICES
BILLING CODE 4164–01–P information, or other information that
consistent with FDA’s good guidance identifies you in the body of your
practices regulation (21 CFR 10.115). comments, that information will be
The guidance represents the current posted on https://www.regulations.gov.
thinking of FDA on ‘‘Labeling for • If you want to submit a comment
Biosimilar Products.’’ It does not with confidential information that you
establish any rights for any person and do not wish to be made available to the
is not binding on FDA or the public. public, submit the comment as a
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![Federal Register / Vol. 83, No. 139 / Thursday, July 19, 2018 / Notices 34143
written/paper submission and in the electronic and written/paper comments possible/actual quality issues that
manner detailed (see ‘‘Written/Paper received, go to https:// require submission of a FAR, the
Submissions’’ and ‘‘Instructions’’). www.regulations.gov and insert the contents of the FAR, who submits the
docket number, found in brackets in the FAR, and when, where, and how they
Written/Paper Submissions
heading of this document, into the should submit it. The draft guidance
Submit written/paper submissions as ‘‘Search’’ box and follow the prompts also addresses followup and final FARs,
follows: and/or go to the Dockets Management which are not required under
• Mail/Hand delivery/Courier (for Staff, 5630 Fishers Lane, Rm. 1061, § 314.81(b), and recommends their
written/paper submissions): Dockets Rockville, MD 20852. submission to inform FDA of the status
Management Staff (HFA–305), Food and You may submit comments on any of root cause investigations and
Drug Administration, 5630 Fishers guidance at any time (see 21 CFR corrective actions taken, if any.
Lane, Rm. 1061, Rockville, MD 20852. 10.115(g)(5)). This draft guidance is being issued
• For written/paper comments Submit written requests for single consistent with FDA’s good guidance
submitted to the Dockets Management copies of the draft guidance to the practices regulation (21 CFR 10.115).
Staff, FDA will post your comment, as Division of Drug Information, Center for The draft guidance, when finalized, will
well as any attachments, except for Drug Evaluation and Research, Food represent the current thinking of FDA
information submitted, marked and and Drug Administration, 10001 New on field alert report submissions. It does
identified, as confidential, if submitted Hampshire Ave., Hillandale Building, not establish any rights for any person
as detailed in ‘‘Instructions.’’ 4th Floor, Silver Spring, MD 20993– and is not binding on FDA or the public.
Instructions: All submissions received
0002, or to the Office of You can use an alternative approach if
must include the Docket No. FDA–
Communication, Outreach and it satisfies the requirements of the
2018–D–2326 for ‘‘Field Alert Report
Development, Center for Biologics applicable statutes and regulations. This
Submission: Questions and Answers;
Evaluation and Research, Food and guidance is not subject to Executive
Draft Guidance for Industry.’’ Received
Drug Administration, 10903 New Order 12866.
comments will be placed in the docket
and, except for those submitted as Hampshire Ave., Bldg. 71, Rm. 3128,
II. Paperwork Reduction Act of 1995
‘‘Confidential Submissions,’’ publicly Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to The draft guidance refers to
viewable at https://www.regulations.gov previously approved collections of
or at the Dockets Management Staff assist that office in processing your
requests. See the SUPPLEMENTARY information that are subject to review by
between 9 a.m. and 4 p.m., Monday the Office of Management and Budget
INFORMATION section for electronic
through Friday. (OMB) under the Paperwork Reduction
• Confidential Submissions—To access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Act of 1995 (44 U.S.C. 3501–3520). The
submit a comment with confidential
Mamta Gautam-Basak, Center for Drug collections of information in 21 CFR
information that you do not wish to be
Evaluation and Research, Food and part 314 have been approved under
made publicly available, submit your
Drug Administration, 10903 New OMB control number 0910–0001.
comments only as a written/paper
submission. You should submit two Hampshire Ave., Bldg. 21, Rm. 2508, III. Electronic Access
copies total. One copy will include the Silver Spring, MD 20993–0002, 301– Persons with access to the internet
information you claim to be confidential 796–0712; Stephen Ripley, Center for may obtain the draft guidance at https://
with a heading or cover note that states Biologics Evaluation and Research, www.fda.gov/Drugs/Guidance
‘‘THIS DOCUMENT CONTAINS Food and Drug Administration, 10903 ComplianceRegulatoryInformation/
CONFIDENTIAL INFORMATION.’’ The New Hampshire Ave., Bldg. 71, Rm. Guidances/default.htm, https://
Agency will review this copy, including 7301, Silver Spring, MD 20993–0002, www.fda.gov/BiologicsBloodVaccines/
the claimed confidential information, in 240–402–7911; or Rachel Harrington, GuidanceComplianceRegulatory
its consideration of comments. The Office of Regulatory Affairs, Food and Information/default.htm, or https://
second copy, which will have the Drug Administration, 10903 New www.regulations.gov.
claimed confidential information Hampshire Ave., Bldg. 32, Rm. 4339,
redacted/blacked out, will be available Silver Spring, MD 20993–0002, 410– Dated: July 13, 2018.
for public viewing and posted on 779–5441. Leslie Kux,
https://www.regulations.gov. Submit SUPPLEMENTARY INFORMATION: Associate Commissioner for Policy.
both copies to the Dockets Management [FR Doc. 2018–15389 Filed 7–18–18; 8:45 am]
I. Background
Staff. If you do not wish your name and BILLING CODE 4164–01–P
contact information to be made publicly FDA is announcing the availability of
available, you can provide this a draft guidance for industry entitled
information on the cover sheet and not ‘‘Field Alert Report Submission: DEPARTMENT OF HEALTH AND
in the body of your comments and you Questions and Answers.’’ The FAR HUMAN SERVICES
must identify this information as regulations found in 21 CFR
‘‘confidential.’’ Any information marked 314.81(b)(1) and 314.98(b) establish an National Institutes of Health
as ‘‘confidential’’ will not be disclosed early warning system to help protect
National Institute on Drug Abuse;
except in accordance with 21 CFR 10.20 patient health. Under these regulations,
Notice of Closed Meeting
and other applicable disclosure law. For NDA and ANDA applicants must submit
certain information to FDA about
sradovich on DSK3GMQ082PROD with NOTICES
more information about FDA’s posting Pursuant to section 10(d) of the
of comments to public dockets, see 80 distributed drug products regulated by Federal Advisory Committee Act, as
FR 56469, September 18, 2015, or access the Center for Drug Evaluation and amended, notice is hereby given of the
the information at: https://www.gpo.gov/ Research or the Center for Biologics following meeting.
fdsys/pkg/FR-2015-09-18/pdf/2015- Evaluation and Research. The meeting will be closed to the
23389.pdf. The draft guidance addresses the FAR public in accordance with the
Docket: For access to the docket to submission requirements and focuses on provisions set forth in sections
read background documents or the topics such as the incidents and 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
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Document Created: 2018-07-19 01:35:37
Document Modified: 2018-07-19 01:35:37
| 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 September 17, 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 | Mamta Gautam-Basak, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 21, Rm. 2508, Silver Spring, MD 20993-0002, 301- 796-0712; Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911; or Rachel Harrington, Office of Regulatory Affairs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 4339, Silver Spring, MD 20993-0002, 410- 779-5441. | |
| FR Citation | 83 FR 34142 |
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