83 FR 12259 - Immediately in Effect Guidance for Industry; Compliance Policy for Combination Product Postmarketing Safety Reporting; 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 | 12259-12260 | |
| FR Document | 2018-05688 |
[Federal Register Volume 83, Number 55 (Wednesday, March 21, 2018)] [Rules and Regulations] [Pages 12259-12260] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-05688] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 4 [Docket No. FDA-2008-N-0424] Immediately in Effect Guidance for Industry; Compliance Policy for Combination Product Postmarketing Safety Reporting; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notification of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) is announcing the availability of an immediately in effect guidance for industry entitled ``Compliance Policy for Combination Product Postmarketing Safety Reporting.'' This guidance describes FDA's compliance policy for combination product applicants and constituent part applicants and activities under FDA regulations that addresses combination product postmarketing safety reporting. This guidance is immediately in effect, but it remains subject to comment in accordance with the Agency's good guidance practices. DATES: The announcement of the guidance is published in the Federal Register on March 21, 2018. ADDRESSES: You may submit either electronic or written comments on 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 ``Compliance Policy for Combination Product Postmarketing Safety Reporting.'' 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 guidance to the Office of Combination Products, Food and Drug Administration, Bldg. 32, Rm. 5129, 10903 New Hampshire Ave., Silver Spring, MD 20993. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Melissa Burns, Office of Combination [[Page 12260]] Products, Food and Drug Administration, 301-796-5616, [email protected]. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of an immediately in effect guidance for industry entitled ``Compliance Policy for Combination Product Postmarketing Safety Reporting.'' This guidance describes FDA's compliance policy for combination product applicants and constituent part applicants and activities under 21 CFR part 4, subpart B, which was published in the Federal Register of December 20, 2016 (81 FR 92603) and addresses postmarketing safety reporting for combination products. We are issuing this guidance consistent with our good guidance practices (GGP) regulation (Sec. 10.115 (21 CFR 10.115)). We are implementing this guidance without prior public comment, because we have determined that prior public participation is not feasible or appropriate (see section 701(h)(1)(C)(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371(h)(1)(C)(i)) and Sec. 10.115(g)(2)). We made this determination because FDA needs to communicate its compliance policy in a timely manner given the upcoming compliance deadlines for certain provisions in 21 CFR part 4, subpart B, and the amount of time needed for firms to prepare for them. Although this guidance is immediately effective, it remains subject to comment in accordance with FDA's GGP regulation. Published elsewhere in this issue of the Federal Register, FDA is announcing the availability of the draft guidance entitled ``Postmarketing Safety Reporting for Combination Products.'' This guidance represents the current thinking of FDA on this topic. 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 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 Sec. Sec. 4.102, 4.103, and 4.105 are approved under OMB control number 0910-0834. III. Electronic Access Persons with access to the internet may obtain the guidance at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov. Dated: March 15, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-05688 Filed 3-20-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 55 / Wednesday, March 21, 2018 / Rules and Regulations 12259
whether the product’s labeling meets addresses combination product Submissions,’’ publicly viewable at
the requirements of the FHSA. postmarketing safety reporting. This https://www.regulations.gov or at the
guidance is immediately in effect, but it Dockets Management Staff between 9
VII. Effect on State and Local Laws
remains subject to comment in a.m. and 4 p.m., Monday through
In general, the preemption language accordance with the Agency’s good Friday.
in section 18(b)(1)(A) of the FHSA guidance practices. • Confidential Submissions—To
provides that if a hazardous substance DATES: The announcement of the submit a comment with confidential
or its packaging is subject to a guidance is published in the Federal information that you do not wish to be
cautionary labeling requirement under Register on March 21, 2018. made publicly available, submit your
the FHSA designed to protect against a comments only as a written/paper
ADDRESSES: You may submit either
risk of illness or injury associated with submission. You should submit two
electronic or written comments on
the substance, no State or political copies total. One copy will include the
Agency guidances at any time as
subdivision of a State may establish or information you claim to be confidential
follows:
continue in effect a cautionary labeling with a heading or cover note that states
requirement applicable to a hazardous Electronic Submissions ‘‘THIS DOCUMENT CONTAINS
substance or packaging that is designed Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The
to protect against the same risk of illness following way: Agency will review this copy, including
or injury, unless the cautionary labeling • Federal eRulemaking Portal: the claimed confidential information, in
requirement is identical to the labeling https://www.regulations.gov. Follow the its consideration of comments. The
requirement under the FHSA. 15 U.S.C. instructions for submitting comments. second copy, which will have the
1261n. As mentioned, this document Comments submitted electronically, claimed confidential information
provides guidance to industry. This including attachments, to https:// redacted/blacked out, will be available
guidance does not have binding legal www.regulations.gov will be posted to for public viewing and posted on
force, does not constitute a rule, and the docket unchanged. Because your https://www.regulations.gov. Submit
thus, does not have preemptive effect. comment will be made public, you are both copies to the Dockets Management
However, the underlying duty to label a solely responsible for ensuring that your Staff. If you do not wish your name and
hazardous household product arises comment does not include any contact information to be made publicly
from the FHSA. This underlying confidential information that you or a available, you can provide this
statutory obligation preempts state and third party may not wish to be posted, information on the cover sheet and not
local non-identical cautionary labeling such as medical information, your or in the body of your comments and you
requirements that are designed to anyone else’s Social Security number, or must identify this information as
protect against the same risk of injury or confidential business information, such ‘‘confidential.’’ Any information marked
illness. as a manufacturing process. Please note as ‘‘confidential’’ will not be disclosed
Alberta E. Mills, that if you include your name, contact except in accordance with 21 CFR 10.20
information, or other information that and other applicable disclosure law. For
Secretary, Consumer Product Safety
Commission. identifies you in the body of your more information about FDA’s posting
comments, that information will be of comments to public dockets, see 80
[FR Doc. 2018–05580 Filed 3–20–18; 8:45 am]
posted on https://www.regulations.gov. FR 56469, September 18, 2015, or access
BILLING CODE 6355–01–P
• If you want to submit a comment the information at: https://www.gpo.gov/
with confidential information that you fdsys/pkg/FR-2015-09-18/pdf/2015-
do not wish to be made available to the 23389.pdf.
DEPARTMENT OF HEALTH AND Docket: For access to the docket to
HUMAN SERVICES public, submit the comment as a
written/paper submission and in the read background documents or the
manner detailed (see ‘‘Written/Paper electronic and written/paper comments
Food and Drug Administration received, go to https://
Submissions’’ and ‘‘Instructions’’).
www.regulations.gov and insert the
21 CFR Part 4 Written/Paper Submissions docket number, found in brackets in the
[Docket No. FDA–2008–N–0424] Submit written/paper submissions as heading of this document, into the
follows: ‘‘Search’’ box and follow the prompts
Immediately in Effect Guidance for and/or go to the Dockets Management
• Mail/Hand delivery/Courier (for
Industry; Compliance Policy for Staff, 5630 Fishers Lane, Rm. 1061,
written/paper submissions): Dockets
Combination Product Postmarketing Rockville, MD 20852.
Management Staff (HFA–305), Food and
Safety Reporting; Availability You may submit comments on any
Drug Administration, 5630 Fishers
AGENCY: Food and Drug Administration, Lane, Rm. 1061, Rockville, MD 20852. guidance at any time (see 21 CFR
HHS. • For written/paper comments 10.115(g)(5)).
submitted to the Dockets Management Submit written requests for single
ACTION: Notification of availability. copies of the guidance to the Office of
Staff, FDA will post your comment, as
SUMMARY: The Food and Drug well as any attachments, except for Combination Products, Food and Drug
Administration (FDA or we) is information submitted, marked and Administration, Bldg. 32, Rm. 5129,
announcing the availability of an identified, as confidential, if submitted 10903 New Hampshire Ave., Silver
immediately in effect guidance for as detailed in ‘‘Instructions.’’ Spring, MD 20993. Send one self-
sradovich on DSK3GMQ082PROD with RULES
industry entitled ‘‘Compliance Policy Instructions: All submissions received addressed adhesive label to assist that
for Combination Product Postmarketing must include the Docket No. FDA– office in processing your requests. See
Safety Reporting.’’ This guidance 2008–N–0424 for ‘‘Compliance Policy the SUPPLEMENTARY INFORMATION section
describes FDA’s compliance policy for for Combination Product Postmarketing for electronic access to the guidance
combination product applicants and Safety Reporting.’’ Received comments document.
constituent part applicants and will be placed in the docket and, except FOR FURTHER INFORMATION CONTACT:
activities under FDA regulations that for those submitted as ‘‘Confidential Melissa Burns, Office of Combination
VerDate Sep<11>2014 16:29 Mar 20, 2018 Jkt 244001 PO 00000 Frm 00013 Fmt 4700 Sfmt 4700 E:\FR\FM\21MRR1.SGM 21MRR1](https://thefederalregister.org/doc/83_FR_12314/page/1.svg)
Document Created: 2018-03-21 00:45:25
Document Modified: 2018-03-21 00:45:25
| 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 | Rules and Regulations | |
| Action | Notification of availability. | |
| Dates | The announcement of the guidance is published in the Federal Register on March 21, 2018. | |
| Contact | Melissa Burns, Office of Combination Products, Food and Drug Administration, 301-796-5616, [email protected] | |
| FR Citation | 83 FR 12259 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR