83 FR 12292 - Postmarketing Safety Reporting for Combination Products; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 55 (March 21, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 55 (March 21, 2018)
| Page Range | 12292-12294 | |
| FR Document | 2018-05687 |
[Federal Register Volume 83, Number 55 (Wednesday, March 21, 2018)] [Proposed Rules] [Pages 12292-12294] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-05687] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 4 [Docket No. FDA-2008-N-0424] Postmarketing Safety Reporting for Combination Products; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notification of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry and FDA staff entitled ``Postmarketing Safety Reporting for Combination Products.'' This draft guidance addresses certain means by which applicants may comply with the final rule on postmarketing safety reporting (PMSR) requirements for combination products that FDA issued on December 20, 2016. Combination products are products composed of two or more different types of medical products (drug, device, and/or biological product). Although the PMSR regulations for drugs, devices, and biological products share many similarities, each set of regulations establishes distinct postmarketing reporting requirements, standards, and timeframes. The final rule provides clarity on the PMSR requirements for combination products to ensure consistent and complete reporting while avoiding duplication. This draft guidance is not final nor is it in effect at this time. DATES: Submit either electronic or written comments on the draft guidance by June 19, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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 either electronic or written comments on any Agency guidances 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-2008-N-0424 for ``Postmarket Safety Reporting for Combination Products.'' 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 Office of Combination Products, Food and Drug Administration, Bldg. 32, Rm. 5129, 10903 New Hampshire Ave., Silver Spring, MD 20993. Send two self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section [[Page 12293]] for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Melissa Burns, Office of Combination Products, Food and Drug Administration, 301-796-5616, [email protected]. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry and FDA staff entitled ``Postmarket Safety Reporting for Combination Products.'' This guidance addresses how to comply with the final rule on postmarketing safety reporting (PMSR) requirements for combination products that FDA issued on December 20, 2016 (81 FR 92603, hereafter referred to as the ``combination product PMSR final rule''). Combination products are products composed of two or more different types of medical products (drug, device, and/or biological product). Although the PMSR regulations for drugs, devices, and biological products share many similarities, each set of regulations establishes distinct reporting requirements, standards, and timeframes. The final rule provides clarity on the PMSR requirements for combination products to ensure consistent and complete reporting while avoiding duplication. Elsewhere in this issue of the Federal Register, FDA is also publishing a compliance policy guidance for the combination product PMSR final rule. The combination product PMSR final rule applies to combination products that are subject to premarket review by FDA. The entities subject to the final rule are ``Combination Product Applicants'' and ``Constituent Part Applicants.'' A Combination Product Applicant holds the only application for a combination product or all the applications for the separately marketed constituent parts of a combination product. A Constituent Part Applicant holds an application for a constituent part of a combination product the constituent parts of which are marketed under separate applications held by different applicants. Major provisions of the final rule are discussed in the guidance including: Application Type-Based PMSR. These requirements apply to both Combination Product Applicants and Constituent Part Applicants and are based on the application type under which the combination product or constituent part received marketing authorization. Constituent Part-Based PMSR. These requirements apply only to Combination Product Applicants and are based on the types of constituent parts included in the combination product. The rule provides mechanisms for Combination Product Applicants to submit a single report to satisfy multiple reporting requirements if all of the information to be reported can be submitted in the same manner and the report satisfies all applicable reporting requirements, including all submission timelines. Information Sharing. These requirements apply only to Constituent Part Applicants, mandating that these applicants share certain adverse event information with one another relating to their combination product. Submission Process for Combination Product PMSR Information. These requirements specify how Combination Product and Constituent Part Applicants must submit PMSR information to the Agency. Records Retention. These requirements specify what records Combination Product and Constituent Part Applicants must maintain and how long to maintain them. II. Other Issues for Consideration The combination product PMSR final rule allows FDA to receive complete, timely postmarketing safety information regarding combination products, which is necessary to assure the continued safety and effectiveness of such products, while minimizing unnecessary duplication and burdens on Combination Product Applicants and Constituent Part Applicants. In developing this guidance document to accompany the final rule, FDA has clarified ways in which Combination Product Applicants can streamline PMSR (see section V.A.3 of the guidance). The guidance clarifies under what circumstances the criteria for being able to submit a single report to FDA are met, i.e., that: (1) The reports can be submitted in the same manner and (2) the combined report satisfies all applicable reporting requirements, including submission timelines (see section IV.C of the guidance). FDA encourages comments on guidance content and mechanisms to improve reporting efficiency while still ensuring complete and timely reporting or topics where additional detailed discussion may be helpful in the guidance. In particular, FDA requests feedback on the following issues for consideration to assist the Agency in determining whether additional streamlining of reports may be appropriate: 1. There may be events that would be reportable for a Combination Product Applicant as a malfunction and/or a Field Alert Report (FAR) and/or a Biological Product Deviation Report (BPDR), e.g., a drug- device combination product that failed to meet specifications may trigger both a malfunction report and FAR. FDA requests feedback on circumstances under which such reporting may be redundant or otherwise unnecessary and, if so, alternative reporting approaches that will assure timely and complete reporting of information to FDA. FDA encourages the use of example scenarios to illustrate circumstances under which submitting one or a subset of such reports may be sufficient to ensure timely and complete reporting. 2. Although outside the scope of the combination product PMSR final rule, in response to comments to the combination product PMSR proposed rule, FDA has addressed certain reporting considerations for entities involved with the manufacture and distribution of combination products but that are not ``applicants'' subject to this rule (see Appendix 3 of the guidance). FDA requests feedback on what, if any, additional guidance would be helpful to such entities. 3. FDA is considering updating the Vaccine Adverse Event Reporting System (VAERS) with data elements similar to those described in section V.B.2 and Appendix 4 of the guidance for the FDA Adverse Events Reporting System (FAERS) and the Electronic Medical Device Reporting (eMDR) system. FDA is also evaluating what additional data elements to include in VAERS with respect to combination products and welcomes comments from combination product vaccine reporters on this topic. 4. FDA also received comments to the combination product PMSR proposed rule related to the safety reporting requirements for investigational combination products. Although investigational combination products are outside the scope of the combination product PMSR final rule and this guidance, we will consider comments from sponsors on the challenges and the need for additional transparency related to safety reporting for investigational combination products. FDA will consider these comments in determining the need for additional policy and guidance on this topic. III. Significance of Guidance 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 [[Page 12294]] on ``Postmarket Safety Reporting for Combination Products.'' 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. 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 314.80(c) and (e), as well as for 21 CFR 314.81(b) are approved under OMB control numbers 0910-0001, 0910-0230, and 0910-0291. The information collection provisions for 21 CFR 600.80 and 600.81 are approved under OMB control number 0910-0308. Those for 21 CFR 606.170 are approved under OMB control number 0910- 0116. Those for 21 CFR 606.171 are approved under OMB control number 0910-0458. The information collection provisions for 21 CFR 803.50, 803.53, and 803.56 are approved under OMB control numbers 0910-0291 and 0910-0437. The information collection provisions for 21 CFR 806.10 and 806.20 are approved under OMB control number 0910-0359. The information collection provisions for 21 CFR 4.102, 4.103, and 4.105 are approved under OMB control number 0910-0834. V. Electronic Access Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm109110.htm or https://www.regulations.gov. Dated: March 15, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-05687 Filed 3-20-18; 8:45 am] BILLING CODE 4164-01-P
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Issued in Washington, DC, on March 13, Agency guidances at any time as a.m. and 4 p.m., Monday through
2018. follows: Friday.
Rodger A. Dean Jr., • Confidential Submissions—To
Manager, Airspace Policy Group.
Electronic Submissions submit a comment with confidential
[FR Doc. 2018–05584 Filed 3–20–18; 8:45 am] Submit electronic comments in the information that you do not wish to be
BILLING CODE 4910–13–P following way: made publicly available, submit your
• Federal eRulemaking Portal: comments only as a written/paper
https://www.regulations.gov. Follow the submission. You should submit two
DEPARTMENT OF HEALTH AND instructions for submitting comments. copies total. One copy will include the
HUMAN SERVICES Comments submitted electronically, information you claim to be confidential
including attachments, to https:// with a heading or cover note that states
Food and Drug Administration www.regulations.gov will be posted to ‘‘THIS DOCUMENT CONTAINS
the docket unchanged. Because your CONFIDENTIAL INFORMATION.’’ The
21 CFR Part 4 comment will be made public, you are Agency will review this copy, including
solely responsible for ensuring that your the claimed confidential information, in
[Docket No. FDA–2008–N–0424] its consideration of comments. The
comment does not include any
Postmarketing Safety Reporting for confidential information that you or a second copy, which will have the
Combination Products; Draft Guidance third party may not wish to be posted, claimed confidential information
for Industry and Food and Drug such as medical information, your or redacted/blacked out, will be available
Administration Staff; Availability anyone else’s Social Security number, or for public viewing and posted on
confidential business information, such https://www.regulations.gov. Submit
AGENCY: Food and Drug Administration, both copies to the Dockets Management
as a manufacturing process. Please note
HHS. Staff. If you do not wish your name and
that if you include your name, contact
ACTION: Notification of availability. information, or other information that contact information to be made publicly
identifies you in the body of your available, you can provide this
SUMMARY: The Food and Drug information on the cover sheet and not
Administration (FDA or Agency) is comments, that information will be
posted on https://www.regulations.gov. in the body of your comments and you
announcing the availability of a draft must identify this information as
guidance for industry and FDA staff • If you want to submit a comment
‘‘confidential.’’ Any information marked
entitled ‘‘Postmarketing Safety with confidential information that you
as ‘‘confidential’’ will not be disclosed
Reporting for Combination Products.’’ do not wish to be made available to the
except in accordance with 21 CFR 10.20
This draft guidance addresses certain public, submit the comment as a
and other applicable disclosure law. For
means by which applicants may comply written/paper submission and in the
more information about FDA’s posting
with the final rule on postmarketing manner detailed (see ‘‘Written/Paper
of comments to public dockets, see 80
safety reporting (PMSR) requirements Submissions’’ and ‘‘Instructions’’).
FR 56469, September 18, 2015, or access
for combination products that FDA Written/Paper Submissions the information at: https://www.gpo.gov/
issued on December 20, 2016.
fdsys/pkg/FR-2015-09-18/pdf/2015-
Combination products are products Submit written/paper submissions as
23389.pdf.
composed of two or more different types follows:
Docket: For access to the docket to
of medical products (drug, device, and/ • Mail/Hand delivery/Courier (for read background documents or the
or biological product). Although the written/paper submissions): Dockets electronic and written/paper comments
PMSR regulations for drugs, devices, Management Staff (HFA–305), Food and received, go to https://
and biological products share many Drug Administration, 5630 Fishers www.regulations.gov and insert the
similarities, each set of regulations Lane, Rm. 1061, Rockville, MD 20852. docket number, found in brackets in the
establishes distinct postmarketing • For written/paper comments heading of this document, into the
reporting requirements, standards, and submitted to the Dockets Management ‘‘Search’’ box and follow the prompts
timeframes. The final rule provides Staff, FDA will post your comment, as and/or go to the Dockets Management
clarity on the PMSR requirements for well as any attachments, except for Staff, 5630 Fishers Lane, Rm. 1061,
combination products to ensure information submitted, marked and Rockville, MD 20852.
consistent and complete reporting while identified, as confidential, if submitted You may submit comments on any
avoiding duplication. This draft as detailed in ‘‘Instructions.’’ guidance at any time (see 21 CFR
guidance is not final nor is it in effect Instructions: All submissions received 10.115(g)(5)).
at this time. must include the Docket No. FDA– Submit written requests for single
sradovich on DSK3GMQ082PROD with PROPOSALS
DATES: Submit either electronic or 2008–N–0424 for ‘‘Postmarket Safety copies of the draft guidance to the Office
written comments on the draft guidance Reporting for Combination Products.’’ of Combination Products, Food and
by June 19, 2018 to ensure that the Received comments will be placed in Drug Administration, Bldg. 32, Rm.
Agency considers your comment on this the docket and, except for those 5129, 10903 New Hampshire Ave.,
draft guidance before it begins work on submitted as ‘‘Confidential Silver Spring, MD 20993. Send two self-
the final version of the guidance. Submissions,’’ publicly viewable at addressed adhesive label to assist that
ADDRESSES: You may submit either https://www.regulations.gov or at the office in processing your requests. See
electronic or written comments on any Dockets Management Staff between 9 the SUPPLEMENTARY INFORMATION section
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![12294 Federal Register / Vol. 83, No. 55 / Wednesday, March 21, 2018 / Proposed Rules
on ‘‘Postmarket Safety Reporting for DEPARTMENT OF HEALTH AND including attachments, to https://
Combination Products.’’ It does not HUMAN SERVICES www.regulations.gov will be posted to
establish any rights for any person and the docket unchanged. Because your
is not binding on FDA or the public. Food and Drug Administration comment will be made public, you are
You can use an alternative approach if solely responsible for ensuring that your
it satisfies the requirements of the 21 CFR Parts 1100, 1140, and 1143 comment does not include any
applicable statutes and regulations. This [Docket No. FDA–2017–N–6565]
confidential information that you or a
guidance is not subject to Executive third party may not wish to be posted,
RIN 0910–AH60 such as medical information, your or
Order 12866.
anyone else’s Social Security number, or
IV. Paperwork Reduction Act of 1995 Regulation of Flavors in Tobacco confidential business information, such
Products as a manufacturing process. Please note
This guidance refers to previously that if you include your name, contact
AGENCY: Food and Drug Administration,
approved collections of information information, or other information that
HHS.
found in FDA regulations. These identifies you in the body of your
collections of information are subject to ACTION:Advance notice of proposed
comments, that information will be
rulemaking.
review by the Office of Management and posted on https://www.regulations.gov.
Budget (OMB) under the Paperwork SUMMARY: The Food and Drug • If you want to submit a comment
Reduction Act of 1995 (44 U.S.C. 3501– Administration (FDA) is issuing this with confidential information that you
3520). The collections of information in advance notice of proposed rulemaking do not wish to be made available to the
21 CFR 314.80(c) and (e), as well as for (ANPRM) to obtain information related public, submit the comment as a
21 CFR 314.81(b) are approved under to the role that flavors play in tobacco written/paper submission and in the
OMB control numbers 0910–0001, products. Specifically, this ANPRM is manner detailed (see ‘‘Written/Paper
0910–0230, and 0910–0291. The seeking comments, data, research Submissions’’ and ‘‘Instructions’’).
information collection provisions for 21 results, or other information about, Written/Paper Submissions
CFR 600.80 and 600.81 are approved among other things, how flavors attract
Submit written/paper submissions as
under OMB control number 0910–0308. youth to initiate tobacco product use
follows:
Those for 21 CFR 606.170 are approved and about whether and how certain • Mail/Hand delivery/Courier (for
under OMB control number 0910–0116. flavors may help adult cigarette smokers written/paper submissions): Dockets
Those for 21 CFR 606.171 are approved reduce cigarette use and switch to Management Staff (HFA–305), Food and
under OMB control number 0910–0458. potentially less harmful products. FDA Drug Administration, 5630 Fishers
The information collection provisions is seeking this information to inform Lane, Rm. 1061, Rockville, MD 20852.
for 21 CFR 803.50, 803.53, and 803.56 regulatory actions FDA might take with • For written/paper comments
respect to tobacco products with flavors, submitted to the Dockets Management
are approved under OMB control
under the Federal Food, Drug, and Staff, FDA will post your comment, as
numbers 0910–0291 and 0910–0437.
Cosmetic Act (FD&C Act), as amended well as any attachments, except for
The information collection provisions
by the Family Smoking Prevention and information submitted, marked and
for 21 CFR 806.10 and 806.20 are Tobacco Control Act (Tobacco Control
approved under OMB control number identified, as confidential, if submitted
Act). Potential regulatory actions as detailed in ‘‘Instructions.’’
0910–0359. The information collection include, but are not limited to, tobacco
provisions for 21 CFR 4.102, 4.103, and Instructions: All submissions received
product standards and restrictions on must include the Docket No. FDA–
4.105 are approved under OMB control sale and distribution of tobacco 2017–N–6565 for ‘‘Regulation of Flavors
number 0910–0834. products with flavors. in Tobacco Products.’’ Received
V. Electronic Access DATES: Submit either electronic or comments, those filed in a timely
written comments by June 19, 2018. manner (see ADDRESSES), will be placed
Persons with access to the internet ADDRESSES: You may submit comments in the docket and, except for those
may obtain the draft guidance at either as follows. Please note that late, submitted as ‘‘Confidential
https://www.fda.gov/Combination untimely filed comments will not be Submissions,’’ publicly viewable at
Products/GuidanceRegulatory considered. Electronic comments must https://www.regulations.gov or at the
Information/ucm109110.htm or https:// be submitted on or before June 19, 2018. Dockets Management Staff between 9
www.regulations.gov. The https://www.regulations.gov a.m. and 4 p.m., Monday through
Dated: March 15, 2018. electronic filing system will accept Friday.
comments until midnight Eastern Time • Confidential Submissions—To
Leslie Kux, submit a comment with confidential
at the end of June 19, 2018. Comments
Associate Commissioner for Policy. received by mail/hand delivery/courier information that you do not wish to be
[FR Doc. 2018–05687 Filed 3–20–18; 8:45 am] (for written/paper submissions) will be made publicly available, submit your
BILLING CODE 4164–01–P considered timely if they are comments only as a written/paper
postmarked or the delivery service submission. You should submit two
acceptance receipt is on or before that copies total. One copy will include the
date. information you claim to be confidential
sradovich on DSK3GMQ082PROD with PROPOSALS
with a heading or cover note that states
Electronic Submissions ‘‘THIS DOCUMENT CONTAINS
Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The
following way: Agency will review this copy, including
• Federal eRulemaking Portal: the claimed confidential information, in
https://www.regulations.gov. Follow the its consideration of comments. The
instructions for submitting comments. second copy, which will have the
Comments submitted electronically, claimed confidential information
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Document Created: 2018-03-21 00:45:38
Document Modified: 2018-03-21 00:45:38
| 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 | Proposed Rules | |
| Action | Notification of availability. | |
| Dates | Submit either electronic or written comments on the draft guidance by June 19, 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 | Melissa Burns, Office of Combination Products, Food and Drug Administration, 301-796-5616, [email protected] | |
| FR Citation | 83 FR 12292 |
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