83 FR 8998 - Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 42 (March 2, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 42 (March 2, 2018)
| Page Range | 8998-9000 | |
| FR Document | 2018-04181 |
[Federal Register Volume 83, Number 42 (Friday, March 2, 2018)] [Notices] [Pages 8998-9000] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-04181] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-D-0338] Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance entitled ``Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act.'' The draft guidance is intended to describe FDA's interpretation of terms used in the definitions of ``suspect product'' and ``illegitimate product'' in the Drug Supply Chain Security Act (DSCSA), for purposes of trading [[Page 8999]] partners' verification obligations (including notification). The draft guidance lays out FDA's current understanding of the following key terms for such purposes: Counterfeit, diverted, fraudulent transaction, and unfit for distribution. DATES: Submit either electronic or written comments on the draft guidance by April 2, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2018-D-0338 for ``Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act.'' 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 office 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: Sarah Venti, Office of Compliance, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-3130, [email protected]. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ``Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act.'' On November 27, 2013, the DSCSA (Pub. L. 113-54) was signed into law. Section 202 of the DSCSA added section 581 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee), which sets forth definitions for the DSCSA. ``Suspect product'' is defined in section 581(21) of the FD&C Act, and ``illegitimate product'' is defined in section 581(8). FDA is announcing the availability of this draft guidance to describe the Agency's interpretation of terms used in the definitions of ``suspect product'' and ``illegitimate product'' in the DSCSA, for purposes of trading partners' verification obligations (including notification) under section 582(b)(4), (c)(4), (d)(4), and (e)(4), respectively of the FD&C Act (21 U.S.C. 360eee-1(b)(4), (c)(4), (d)(4), and (e)(4)). The draft guidance lays out FDA's current understanding of the following key terms for such purposes: Counterfeit, diverted, fraudulent transaction, and unfit for distribution. 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 definitions of suspect product and illegitimate product for verification obligations under the DSCSA. 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. [[Page 9000]] II. Electronic Access Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or https://www.regulations.gov. Dated: February 23, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-04181 Filed 3-1-18; 8:45 am] BILLING CODE 4164-01-P
![8998 Federal Register / Vol. 83, No. 42 / Friday, March 2, 2018 / Notices
the claimed confidential information, in current thinking of FDA on this topic. made editorial changes to improve
its consideration of comments. The It does not establish any rights for any clarity. The guidance announced in this
second copy, which will have the person and is not binding on FDA or the notice finalizes the draft guidance dated
claimed confidential information public. You can use an alternative November 2016.
redacted/blacked out, will be available approach if it satisfies the requirements
II. Paperwork Reduction Act of 1995
for public viewing and posted on of the applicable statutes and
https://www.regulations.gov. Submit regulations. This guidance is not subject The guidance refers to previously
both copies to the Dockets Management to Executive Order 12866. approved collections of information
Staff. If you do not wish your name and In the Federal Register of May 27, found in FDA regulations. These
contact information to be made publicly 2016 (81 FR 33742), we published a collections of information are subject to
available, you can provide this final rule amending our Nutrition and review by the Office of Management and
information on the cover sheet and not Supplement Facts label regulations. The Budget (OMB) under the Paperwork
in the body of your comments and you final rule provides a definition of Reduction Act of 1995 (44 U.S.C. 3501–
must identify this information as dietary fiber as non-digestible soluble 3520). The collections of information in
‘‘confidential.’’ Any information marked and insoluble carbohydrates (with three § 101.9 have been approved under OMB
as ‘‘confidential’’ will not be disclosed or more monomeric units), and lignin control number 0910–0813.
except in accordance with 21 CFR 10.20 that are intrinsic and intact in plants; III. Electronic Access
and other applicable disclosure law. For isolated or synthetic non-digestible
more information about FDA’s posting carbohydrates (with three or more Persons with access to the internet
of comments to public dockets, see 80 monomeric units) determined by FDA to may obtain the guidance at either
FR 56469, September 18, 2015, or access have physiological effects that are https://www.fda.gov/FoodGuidances or
the information at: https://www.gpo.gov/ beneficial to human health https://www.regulations.gov. Use the
fdsys/pkg/FR-2015-09-18/pdf/2015- (§ 101.9(c)(6)(i)) (21 CFR 101.9(c)(6)(i)). FDA website listed in the previous
23389.pdf. One mechanism by which a sentence to find the most current
Docket: For access to the docket to manufacturer could request an version of the guidance.
read background documents or the amendment to the list of isolated or Dated: February 27, 2018.
electronic and written/paper comments synthetic non-digestible carbohydrates Leslie Kux,
received, go to https:// that meet the dietary fiber definition is Associate Commissioner for Policy.
www.regulations.gov and insert the by using the citizen petition process in [FR Doc. 2018–04280 Filed 3–1–18; 8:45 am]
docket number, found in brackets in the 21 CFR 10.30. If an isolated or synthetic
BILLING CODE 4164–01–P
heading of this document, into the non-digestible carbohydrate meets the
‘‘Search’’ box and follow the prompts dietary fiber definition, then it would be
and/or go to the Dockets Management added to the list of dietary fibers in DEPARTMENT OF HEALTH AND
Staff, 5630 Fishers Lane, Rm. 1061, § 101.9(c)(6)(i). HUMAN SERVICES
Rockville, MD 20852. In the Federal Register of November
You may submit comments on any 23, 2016, (81 FR 84516), we announced Food and Drug Administration
guidance at any time (see 21 CFR the availability of a draft guidance for
[Docket No. FDA–2018–D–0338]
10.115(g)(5)). industry entitled ‘‘Scientific Evaluation
Submit written requests for single of the Evidence on the Beneficial Definitions of Suspect Product and
copies of the guidance to the Office of Physiological Effects of Isolated or Illegitimate Product for Verification
Nutrition and Food Labeling, Center for Synthetic Non-Digestible Carbohydrates Obligations Under the Drug Supply
Food Safety and Applied Nutrition, Submitted as a Citizen Petition (21 CFR Chain Security Act; Draft Guidance for
Food and Drug Administration, 5001 10.30)’’ and gave interested parties an Industry; Availability
Campus Dr., College Park, MD 20740. opportunity to submit comments by
Send two self-addressed adhesive labels January 23, 2017, for us to consider AGENCY: Food and Drug Administration,
to assist that office in processing your before beginning work on the final HHS.
request. See the SUPPLEMENTARY version of the guidance. In the Federal ACTION: Notice of availability.
INFORMATION section for electronic Register of January 13, 2017 (82 FR
access to the guidance. 4225), we extended the comment period SUMMARY: The Food and Drug
to February 13, 2017. We received Administration (FDA or Agency) is
FOR FURTHER INFORMATION CONTACT:
several comments on the draft guidance announcing the availability of a draft
Paula R. Trumbo, Center for Food Safety
and have modified the final guidance guidance entitled ‘‘Definitions of
and Applied Nutrition (HFS–830), Food
where appropriate. Changes to the Suspect Product and Illegitimate
and Drug Administration, 5001 Campus
guidance include: (1) The inclusion of Product for Verification Obligations
Dr., College Park, MD 20740, 240–402–
studies on diseased populations under Under the Drug Supply Chain Security
2579.
certain circumstances as part of our Act.’’ The draft guidance is intended to
SUPPLEMENTARY INFORMATION: describe FDA’s interpretation of terms
evaluation of the totality of the scientific
I. Background evidence; (2) additional detail and used in the definitions of ‘‘suspect
clarity on the physiological endpoints product’’ and ‘‘illegitimate product’’ in
We are announcing the availability of the Drug Supply Chain Security Act
a guidance for industry entitled that we consider when reviewing the
scientific evidence; and (3) additional (DSCSA), for purposes of trading
‘‘Scientific Evaluation of the Evidence
daltland on DSKBBV9HB2PROD with NOTICES
on the Beneficial Physiological Effects detail regarding factors we consider
when evaluating the strength of the result of the processing of foods and other sources,
of Isolated or Synthetic Non-Digestible to the extent that the ingredients in and of
Carbohydrates Submitted as a Citizen scientific evidence.1 In addition, we themselves have a specific chemical structure
Petition (21 CFR 10.30).’’ We are issuing (carbohydrate composition and non-digestible bond
1 This guidance addresses the scientific linkages). These isolated non-digestible
this guidance consistent with our good evaluation of synthetic non-digestible carbohydrates may or may not vary in size.
guidance practices regulation (21 CFR carbohydrates and isolated non-digestible Examples of isolated non-digestible carbohydrates
10.115). The guidance represents the carbohydrate ingredients that are produced as a include cellulose, guar gum, and pectin.
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![9000 Federal Register / Vol. 83, No. 42 / Friday, March 2, 2018 / Notices
II. Electronic Access anyone else’s Social Security number, or ‘‘confidential.’’ Any information marked
Persons with access to the internet confidential business information, such as ‘‘confidential’’ will not be disclosed
may obtain the draft guidance at either as a manufacturing process. Please note except in accordance with 21 CFR 10.20
https://www.fda.gov/Drugs/Guidance that if you include your name, contact and other applicable disclosure law. For
ComplianceRegulatoryInformation/ information, or other information that more information about FDA’s posting
Guidances/default.htm, https:// identifies you in the body of your of comments to public dockets, see 80
www.fda.gov/BiologicsBloodVaccines/ comments, that information will be FR 56469, September 18, 2015, or access
GuidanceComplianceRegulatory posted on https://www.regulations.gov. the information at: https://www.gpo.gov/
• If you want to submit a comment fdsys/pkg/FR-2015-09-18/pdf/2015-
Information/Guidances/default.htm, or
with confidential information that you 23389.pdf.
https://www.regulations.gov.
do not wish to be made available to the Docket: For access to the docket to
Dated: February 23, 2018. public, submit the comment as a read background documents or the
Leslie Kux, written/paper submission and in the electronic and written/paper comments
Associate Commissioner for Policy. manner detailed (see ‘‘Written/Paper received, go to https://
[FR Doc. 2018–04181 Filed 3–1–18; 8:45 am] Submissions’’ and ‘‘Instructions’’). www.regulations.gov and insert the
BILLING CODE 4164–01–P
Written/Paper Submissions docket number, found in brackets in the
heading of this document, into the
Submit written/paper submissions as ‘‘Search’’ box and follow the prompts
DEPARTMENT OF HEALTH AND follows: and/or go to the Dockets Management
HUMAN SERVICES • Mail/Hand delivery/Courier (for
Staff, 5630 Fishers Lane, Rm. 1061,
written/paper submissions): Dockets
Rockville, MD 20852.
Food and Drug Administration Management Staff (HFA–305), Food and
You may submit comments on any
Drug Administration, 5630 Fishers
[Docket No. FDA–2016–D–4098] guidance at any time (see 21 CFR
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments 10.115(g)(5)).
Reference Amounts Customarily Submit written requests for single
Consumed: List of Products for Each submitted to the Dockets Management
Staff, FDA will post your comment, as copies of the guidance to the Office of
Product Category; Guidance for Nutrition and Food Labeling, Center for
Industry; Availability well as any attachments, except for
information submitted, marked and Food Safety and Applied Nutrition,
AGENCY: Food and Drug Administration, identified, as confidential, if submitted Food and Drug Administration, 5001
HHS. as detailed in ‘‘Instructions.’’ Campus Dr., College Park, MD 20740.
Instructions: All submissions received Send two self-addressed adhesive labels
ACTION: Notification of availability.
must include the Docket No. FDA– to assist that office in processing your
SUMMARY: The Food and Drug 2016–D–4098 for ‘‘Reference Amounts request. See the SUPPLEMENTARY
Administration (FDA or we) is Customarily Consumed: List of Products INFORMATION section for electronic
announcing the availability of a for Each Product Category.’’ Received access to the guidance.
guidance for industry entitled comments will be placed in the docket FOR FURTHER INFORMATION CONTACT:
‘‘Reference Amounts Customarily and, except for those submitted as Jillonne Kevala, Center for Food Safety
Consumed: List of Products for Each ‘‘Confidential Submissions,’’ publicly and Applied Nutrition, Food and Drug
Product Category.’’ The guidance viewable at https://www.regulations.gov Administration, 5001 Campus Dr.,
provides examples of products that or at the Dockets Management Staff College Park, MD 20740, 240–402–1450.
belong to product categories included in between 9 a.m. and 4 p.m., Monday SUPPLEMENTARY INFORMATION:
the tables of Reference Amounts through Friday.
Customarily Consumed (RACCs) per • Confidential Submissions—To I. Background
Eating Occasion established in our submit a comment with confidential We are announcing the availability of
regulations. information that you do not wish to be a guidance for industry entitled
DATES: The announcement of the made publicly available, submit your ‘‘Reference Amounts Customarily
guidance is published in the Federal comments only as a written/paper Consumed: List of Products for Each
Register on March 2, 2018. submission. You should submit two Product Category.’’ We are issuing this
ADDRESSES: You may submit either copies total. One copy will include the guidance consistent with our good
electronic or written comments on FDA information you claim to be confidential guidance practices regulation (21 CFR
guidances at any time as follows: with a heading or cover note that states 10.115). The guidance represents the
‘‘THIS DOCUMENT CONTAINS current thinking of FDA on this topic.
Electronic Submissions CONFIDENTIAL INFORMATION.’’ We It does not establish any rights for any
Submit electronic comments in the will review this copy, including the person and is not binding on FDA or the
following way: claimed confidential information, in our public. You can use an alternative
• Federal eRulemaking Portal: consideration of comments. The second approach if it satisfies the requirements
https://www.regulations.gov. Follow the copy, which will have the claimed of the applicable statutes and
instructions for submitting comments. confidential information redacted/ regulations. This guidance is not subject
Comments submitted electronically, blacked out, will be available for public to Executive Order 12866.
including attachments, to https:// viewing and posted on https:// This guidance is intended to help
www.regulations.gov will be posted to www.regulations.gov. Submit both industry comply with the statutory
daltland on DSKBBV9HB2PROD with NOTICES
the docket unchanged. Because your copies to the Dockets Management Staff. requirement, under section
comment will be made public, you are If you do not wish your name and 403(q)(1)(A)(i) of the Federal Food,
solely responsible for ensuring that your contact information to be made publicly Drug, and Cosmetic Act (FD&C Act) (21
comment does not include any available, you can provide this U.S.C. 343(q)(1)(A)(i)), that food that is
confidential information that you or a information on the cover sheet and not intended for human consumption and
third party may not wish to be posted, in the body of your comments and you offered for sale bear nutrition
such as medical information, your or must identify this information as information that provides a serving size
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Document Created: 2018-03-01 23:56:50
Document Modified: 2018-03-01 23:56:50
| 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 April 2, 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 | Sarah Venti, Office of Compliance, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-3130, [email protected] | |
| FR Citation | 83 FR 8998 |
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