81 FR 89110 - Preparation of Food Contact Notifications for Food Contact Substances in Contact With Infant Formula and/or Human Milk; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 237 (December 9, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 237 (December 9, 2016)
| Page Range | 89110-89112 | |
| FR Document | 2016-29587 |
[Federal Register Volume 81, Number 237 (Friday, December 9, 2016)] [Notices] [Pages 89110-89112] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-29587] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-D-1814] Preparation of Food Contact Notifications for Food Contact Substances in Contact With Infant Formula and/or Human Milk; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- [[Page 89111]] SUMMARY: The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled ``Preparation of Food Contact Notifications for Food Contact Substances in Contact with Infant Formula and/or Human Milk.'' The draft guidance, when finalized, will provide industry with our current thinking on how to prepare a food contact notification (FCN) submission for our review and evaluation of the safety of food contact substances (FCSs) used in contact with infant formula and/or human milk. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that we consider your comment on the draft guidance before we begin work on the final version of the guidance, submit either electronic or written comments on the draft guidance by February 7, 2017. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://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 http://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2016-D-1814 for ``Preparation of Food Contact Notifications for Food Contact Substances in Contact with Infant Formula and/or Human Milk.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit written requests for single copies of the draft guidance to the Division of Food Contact Notifications, Office of Food Additive Safety, Center for Food Safety and Applied Nutrition (HFS-275), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740. Send two self-addressed adhesive labels to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance. FOR FURTHER INFORMATION CONTACT: Kelly Randolph, Center for Food Safety and Applied Nutrition (HFS-275), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1188. SUPPLEMENTARY INFORMATION: I. Background We are announcing the availability of a draft guidance for industry entitled ``Preparation of Food Contact Notifications for Food Contact Substances in Contact with Infant Formula and/or Human Milk.'' We are issuing the draft guidance consistent with our good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent 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 alternate approach if it satisfies the requirements of the applicable statutes and regulations. Section 409 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 348) establishes an FCN process as the primary method by which we regulate food additives that are FCSs. As defined in section 409(h)(6) of the FD&C Act, the term ``food contact substance'' means any substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use is not intended to have any technical effect in such food. Under section 409(h) of the FD&C Act and FDA's implementing regulations, FCN submissions must contain a comprehensive discussion of the basis for the manufacturer's or supplier's determination that the use of the FCS that is the subject of the notification is safe. This draft guidance contains recommendations regarding how the scientific information in FCNs for infant food use should demonstrate that the FCS is safe for the specific intended use in contact with infant food. For purposes of the draft guidance, infant food is limited to infant formula and/or human milk, and this draft guidance focuses on infants 0-6 months in age. The draft guidance discusses our [[Page 89112]] recommendations and provides information for: Chemistry recommendations, including migration testing and exposure estimation; toxicology recommendations including exposure-based testing tiers, minimum testing recommendations, and age-dependent cancer risk analysis of carcinogenic constituents; and administrative recommendations including acknowledgment of an FCN, non-acceptance of an FCN, final letter, inventory of effective FCNs, and premarket notification consultations. II. Paperwork Reduction Act of 1995 This draft guidance contains proposed information collection provisions 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). ``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. Federal law at 44 U.S.C. 3506(c)(2)(A) requires Federal Agencies to publish a 60-day notice in the Federal Register for each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, we will publish a 60-day notice of the proposed collection of information in a future issue of the Federal Register. III. Electronic Access Persons with access to the Internet may obtain the draft guidance at either http://www.fda.gov/FoodGuidances or http://www.regulations.gov. Use the FDA Web sites listed in the previous sentence to find the most current version of the guidance. Dated: December 2, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-29587 Filed 12-8-16; 8:45 am] BILLING CODE 4164-01-P
![89110 Federal Register / Vol. 81, No. 237 / Friday, December 9, 2016 / Notices
Docket: For access to the docket to downloads/ForIndustry/UserFees/ III. Meeting Attendance and
read background documents or the PrescriptionDrugUserFee/ Participation
electronic and written/paper comments UCM436448.pdf. The PDUFA V FDA is holding the public meeting on
received, go to http:// performance commitments also call for March 27, 2017, from 10 a.m. to 1 p.m.
www.regulations.gov and insert the a final assessment of the Program to be If you wish to attend this public
docket number, found in brackets in the published by December 31, 2016, for meeting, visit: https://
heading of this document, into the public comment. The final assessment nmemeeting.eventbrite.com. Please
‘‘Search’’ box and follow the prompts can be accessed at http://www.fda.gov/ register by March 20, 2017. If you are
and/or go to the Division of Dockets ForIndustry/UserFees/PrescriptionDrug unable to attend the public meeting in
Management, 5630 Fishers Lane, Rm. UserFee/ucm327030.htm. A public person, you can register to view a live
1061, Rockville, MD 20852. meeting will be held on March 27, 2017, Webcast of the public meeting. You will
FOR FURTHER INFORMATION CONTACT: where the final assessment will be be asked to indicate in your registration
Graham Thompson, Center for Drug discussed and public stakeholders may if you plan to attend in person or via the
Evaluation and Research, Food and present their views on the Program. Webcast. Seating will be limited, so
Drug Administration, 10903 New early registration is recommended.
Hampshire Ave., Bldg. 51, Rm. 1146, II. PDUFA V NME NDA and Original Registration is free and will be on a first-
Silver Spring, MD 20993, 301–796– BLA Review Program come, first-served basis. However, FDA
5003, FAX: 301–847–8443, may limit the number of participants
Graham.Thompson@fda.hhs.gov. FDA’s performance goals for review of
from each organization based on space
SUPPLEMENTARY INFORMATION:
priority and standard new drug
limitations. Registrants will receive
applications, 6 and 10 months confirmation once they have been
I. Background respectively, have been in place since accepted. Onsite registration on the day
The timely review of the safety and the late 1990s. Since that time, of the public meeting will not be
efficacy of new drugs and biologics is additional requirements in the review possible. If you need special
central to FDA’s mission to protect and process and scientific advances in accommodations because of a disability,
promote the public health. Since the product development have made those please contact Graham Thompson (see
implementation of PDUFA I in 1993, goals increasingly challenging to meet, FOR FURTHER INFORMATION CONTACT) at
FDA has used PDUFA resources to particularly for more complex least 7 days before the public meeting.
improve the timeliness and applications like NME NDAs and FDA will hold an open public
predictability of new drug review while original BLAs. FDA further recognizes comment period to give the public an
maintaining FDA’s rigorous standards that increasing communication and opportunity to comment during the
for drug quality, safety and efficacy. transparency between the Agency and public meeting. Registration for open
With the availability of these additional applicants during FDA’s review has the public comment will occur at the
fee resources, FDA was able to agree to potential to increase efficiency in the registration desk on the day of the
certain review performance goals, review process. public meeting on a first-come, first-
including a complete review of NDAs served basis.
and BLAs and taking regulatory action To promote greater transparency and
Transcripts: Please be advised that as
within specified timeframes. The improve communication between the
soon as a transcript of the public
managed review processes put in place FDA review team and the applicant, meeting is available, it will be accessible
to accomplish this, and the process FDA implemented a new review model at https://www.regulations.gov. It may
enhancements including investments in for NME NDAs and original BLAs in be viewed at the Division of Dockets
modernized post-market safety and PDUFA V. The Program provides Management (see ADDRESSES). A link to
regulatory science over subsequent opportunities for increased the transcript will also be available on
reauthorizations of PDUFA, have communication between FDA and the Internet at http://www.fda.gov/
revolutionized the new drug review applicants, including mid-cycle and Drugs/NewsEvents/ucm501389.htm.
process, helping to bring critical late-cycle meetings. To accommodate
Dated: December 2, 2016.
products to market for patients. The the increased interaction during
Leslie Kux,
PDUFA program has been reauthorized regulatory review and to address the
every 5 years, with the most recent and Associate Commissioner for Policy.
need for additional time to review these
fifth authorization occurring in 2012. [FR Doc. 2016–29589 Filed 12–8–16; 8:45 am]
complex applications, FDA’s review
The PDUFA V Performance Goals and clock begins after the 60-day BILLING CODE 4164–01–P
Procedures for Fiscal Years 2013 administrative filing review period for
through 2017 can be accessed at http:// applications reviewed under the
www.fda.gov/downloads/ForIndustry/ DEPARTMENT OF HEALTH AND
Program. HUMAN SERVICES
UserFees/PrescriptionDrugUserFee/
UCM270412.pdf. The goal of the Program is to improve
the efficiency and effectiveness of the Food and Drug Administration
PDUFA V introduced a new review
program for NME NDAs and original first-cycle review process by increasing [Docket No. FDA–2016–D–1814]
BLAs to enhance review transparency communications during application
and communication between FDA and review. This will provide sponsors with Preparation of Food Contact
applicants on these complex the opportunity to clarify previous Notifications for Food Contact
mstockstill on DSK3G9T082PROD with NOTICES
applications. FDA committed to submissions and provide additional Substances in Contact With Infant
engaging an independent contractor to data and analyses that are readily Formula and/or Human Milk; Draft
evaluate the Program to understand the available, potentially avoiding the need Guidance for Industry; Availability
Program’s effect on the review of these for an additional review cycle when AGENCY: Food and Drug Administration,
applications. The interim assessment concerns can be promptly resolved HHS.
was published March 31, 2015, and can without compromising FDA’s standards
ACTION: Notice of availability.
be accessed at http://www.fda.gov/ for approval.
VerDate Sep<11>2014 18:13 Dec 08, 2016 Jkt 241001 PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 E:\FR\FM\09DEN1.SGM 09DEN1](https://thefederalregister.org/doc/81_FR_89347/page/1.svg)
![89112 Federal Register / Vol. 81, No. 237 / Friday, December 9, 2016 / Notices
recommendations and provides SUMMARY: The Food and Drug that if you include your name, contact
information for: Chemistry Administration (FDA or Agency) is information, or other information that
recommendations, including migration announcing the availability of a identifies you in the body of your
testing and exposure estimation; guidance for industry entitled ‘‘Drug comments, that information will be
toxicology recommendations including Supply Chain Security Act posted on https://www.regulations.gov.
exposure-based testing tiers, minimum Implementation: Identification of • If you want to submit a comment
testing recommendations, and age- Suspect Product and Notification.’’ The with confidential information that you
dependent cancer risk analysis of guidance addresses provisions in the do not wish to be made available to the
carcinogenic constituents; and Federal Food, Drug, and Cosmetic Act public, submit the comment as a
administrative recommendations (the FD&C Act), as amended by the Drug written/paper submission and in the
including acknowledgment of an FCN, Supply Chain Security Act (DSCSA). manner detailed (see ‘‘Written/Paper
non-acceptance of an FCN, final letter, The guidance is intended to aid certain Submissions’’ and ‘‘Instructions’’).
inventory of effective FCNs, and trading partners (manufacturers, Written/Paper Submissions
premarket notification consultations. repackagers, wholesale distributors, and
dispensers) in identifying a suspect Submit written/paper submissions as
II. Paperwork Reduction Act of 1995 follows:
product and specific scenarios that
This draft guidance contains proposed • Mail/Hand delivery/Courier (for
could significantly increase the risk of a
information collection provisions that written/paper submissions): Division of
suspect product entering the
are subject to review by the Office of Dockets Management (HFA–305), Food
pharmaceutical distribution supply
Management and Budget (OMB) under and Drug Administration, 5630 Fishers
chain. The guidance also describes how
the Paperwork Reduction Act of 1995 Lane, Rm. 1061, Rockville, MD 20852.
trading partners should notify FDA of • For written/paper comments
(44 U.S.C. 3501–3520). ‘‘Collection of illegitimate product and sets forth a
information’’ is defined in 44 U.S.C. submitted to the Division of Dockets
process for terminating notifications of Management, FDA will post your
3502(3) and 5 CFR 1320.3(c) and illegitimate product in consultation
includes Agency requests or comment, as well as any attachments,
with FDA. This guidance also includes except for information submitted,
requirements that members of the public a new section, for comment purposes
submit reports, keep records, or provide marked, and identified as confidential,
only, that describes when manufacturers if submitted as detailed in
information to a third party. Federal law should notify FDA of a high risk that a
at 44 U.S.C. 3506(c)(2)(A) requires ‘‘Instructions.’’
product is illegitimate. Aside from that Instructions: All submissions received
Federal Agencies to publish a 60-day section, this guidance is a final guidance must include the Docket No. FDA–
notice in the Federal Register for each subsequent to the draft guidance that 2014–D–0609 for ‘‘Drug Supply Chain
proposed collection of information was issued on June 11, 2014. Security Act Implementation:
before submitting the collection to OMB DATES: You may submit either electronic Identification of Suspect Product and
for approval. To comply with this or written comments on Agency Notification; Guidance for Industry;
requirement, we will publish a 60-day guidances at any time. However, the Availability.’’ Received comments will
notice of the proposed collection of portion of this guidance that describes be placed in the docket and, except for
information in a future issue of the when manufacturers should notify FDA those submitted as ‘‘Confidential
Federal Register. if there is a high risk that a product is Submissions,’’ publicly viewable at
III. Electronic Access illegitimate, is being distributed for https://www.regulations.gov or at the
Persons with access to the Internet comment purposes only. To ensure that Division of Dockets Management
may obtain the draft guidance at either the Agency considers your comment on between 9 a.m. and 4 p.m., Monday
http://www.fda.gov/FoodGuidances or this draft section before it begins work through Friday.
http://www.regulations.gov. Use the on the final version of this section of the • Confidential Submissions—To
FDA Web sites listed in the previous guidance, submit either electronic or submit a comment with confidential
sentence to find the most current written comments on this section by information that you do not wish to be
version of the guidance. February 7, 2017. made publicly available, submit your
ADDRESSES: You may submit comments comments only as a written/paper
Dated: December 2, 2016. submission. You should submit two
as follows:
Leslie Kux, copies total. One copy will include the
Associate Commissioner for Policy. Electronic Submissions information you claim to be confidential
[FR Doc. 2016–29587 Filed 12–8–16; 8:45 am] Submit electronic comments in the with a heading or cover note that states,
BILLING CODE 4164–01–P following way: ‘‘THIS DOCUMENT CONTAINS
• Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The
https://www.regulations.gov. Follow the Agency will review this copy, including
DEPARTMENT OF HEALTH AND instructions for submitting comments. the claimed confidential information, in
HUMAN SERVICES Comments submitted electronically, its consideration of comments. The
including attachments, to https:// second copy, which will have the
Food and Drug Administration www.regulations.gov will be posted to claimed confidential information
[Docket No. FDA–2014–D–0609] the docket unchanged. Because your redacted/blacked out, will be available
comment will be made public, you are for public viewing and posted on
Drug Supply Chain Security Act solely responsible for ensuring that your https://www.regulations.gov. Submit
mstockstill on DSK3G9T082PROD with NOTICES
Implementation: Identification of comment does not include any both copies to the Division of Dockets
Suspect Product and Notification; confidential information that you or a Management. If you do not wish your
Guidance for Industry; Availability third party may not wish to be posted, name and contact information to be
AGENCY: Food and Drug Administration, such as medical information, your or made publicly available, you can
HHS. anyone else’s Social Security number, or provide this information on the cover
confidential business information, such sheet and not in the body of your
ACTION: Notice of availability.
as a manufacturing process. Please note comments, and you must identify this
VerDate Sep<11>2014 18:13 Dec 08, 2016 Jkt 241001 PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 E:\FR\FM\09DEN1.SGM 09DEN1](https://thefederalregister.org/doc/81_FR_89347/page/3.svg)
Document Created: 2018-02-14 09:03:29
Document Modified: 2018-02-14 09:03:29
| 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 | Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that we consider your comment on the draft guidance before we begin work on the final version of the guidance, submit either electronic or written comments on the draft guidance by February 7, 2017. | |
| Contact | Kelly Randolph, Center for Food Safety and Applied Nutrition (HFS-275), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1188. | |
| FR Citation | 81 FR 89110 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR