81 FR 89112 - Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification; 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 | 89112-89113 | |
| FR Document | 2016-29588 |
[Federal Register Volume 81, Number 237 (Friday, December 9, 2016)] [Notices] [Pages 89112-89113] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-29588] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-D-0609] Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification; 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 guidance for industry entitled ``Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification.'' The guidance addresses provisions in the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Drug Supply Chain Security Act (DSCSA). The guidance is intended to aid certain trading partners (manufacturers, repackagers, wholesale distributors, and dispensers) in identifying a suspect product and specific scenarios that could significantly increase the risk of a suspect product entering the pharmaceutical distribution supply chain. The guidance also describes how trading partners should notify FDA of illegitimate product and sets forth a process for terminating notifications of illegitimate product in consultation with FDA. This guidance also includes a new section, for comment purposes only, that describes when manufacturers should notify FDA of a high risk that a product is illegitimate. Aside from that section, this guidance is a final guidance subsequent to the draft guidance that was issued on June 11, 2014. DATES: You may submit either electronic or written comments on Agency guidances at any time. However, the portion of this guidance that describes when manufacturers should notify FDA if there is a high risk that a product is illegitimate, is being distributed for comment purposes only. To ensure that the Agency considers your comment on this draft section before it begins work on the final version of this section of the guidance, submit either electronic or written comments on this section by February 7, 2017. ADDRESSES: You may submit comments 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): 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-2014-D-0609 for ``Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification; Guidance for Industry; Availability.'' 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 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 https://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 [[Page 89113]] 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 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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit written requests for single copies of this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Bldg. 4th Floor, Silver Spring, MD 20993-0002; or 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 guidance document. FOR FURTHER INFORMATION CONTACT: Office of Compliance, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-3130, [email protected]. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled ``Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification.'' The guidance addresses provisions in the FD&C Act, as amended by the DSCSA (Pub. L. 113-54). Section 202 of the DSCSA adds section 582(h)(2) to the FD&C Act (21 U.S.C. 360eee-1(h)(2)), which requires FDA to issue guidance to aid certain trading partners (manufacturers, repackagers, wholesale distributors, and dispensers) in identifying a suspect product and terminating notifications. The guidance identifies specific scenarios that could significantly increase the risk of a suspect product entering the pharmaceutical distribution supply chain, and provides recommendations on how trading partners can identify such product and determine whether the product is a suspect product as soon as practicable. Beginning January 1, 2015, section 582 of the FD&C Act required trading partners, upon determining that a product in their possession or control is illegitimate, to notify: (1) FDA and (2) all immediate trading partners that they have reason to believe may have received the illegitimate product, not later than 24 hours after making the determination. Manufacturers are additionally required under section 582(b)(4)(B)(ii)(II) of the FD&C Act to notify FDA and any immediate trading partners that the manufacturer has reason to believe may possess a product manufactured by (or purported to be manufactured by) the manufacturer, not later than 24 hours after the manufacturer determines or is notified by FDA or a trading partner that there is a high risk that a product is illegitimate. Section III.C of this guidance, entitled ``For Manufacturers: High Risk of Illegitimacy Notification'' and highlighted in grey, describes notifications related to products that pose a high risk of illegitimacy, and is marked ``for comment purposes only'' to provide an opportunity for comment before it is finalized. The guidance also addresses how trading partners should notify FDA using Form FDA 3911. In addition, in accordance with section 582(h)(2) of the FD&C Act, the guidance sets forth the process by which trading partners must terminate the notifications using Form FDA 3911, in consultation with FDA, regarding illegitimate product and, for a manufacturer, a product with a high risk of illegitimacy, under section 582(b)(4)(B), (c)(4)(B), (d)(4)(B), and (e)(4)(B) of the FD&C Act. In the Federal Register of June 11, 2014 (79 FR 33564), FDA announced the availability of a draft guidance entitled ``Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification.'' FDA has carefully considered the comments received and made the following changes in response to the comments: Section C, ``For Manufacturers: High Risk of Illegitimacy Notifications,'' on pgs. 8-11 of the guidance, is a new section added in response to comments and questions received. In addition, FDA made minor changes to the Form FDA 3911 and to the instructions for completing the form. This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on ``Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification.'' It does not establish any rights for any person and, with the exception of section IV.B, 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. II. Electronic Access Persons with access to the Internet may obtain the guidance at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or https://www.regulations.gov. III. Paperwork Reduction Act of 1995 This guidance contains 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). The collection of information in this guidance was approved under OMB control number 0910-0806. Dated: December 5, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-29588 Filed 12-8-16; 8:45 am] BILLING CODE 4164-01-P
![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
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![Federal Register / Vol. 81, No. 237 / Friday, December 9, 2016 / Notices 89113
information as ‘‘confidential.’’ Any suspect product entering the practices regulation (21 CFR 10.115).
information marked as ‘‘confidential’’ pharmaceutical distribution supply The guidance represents the current
will not be disclosed except in chain, and provides recommendations thinking of FDA on ‘‘Drug Supply Chain
accordance with 21 CFR 10.20 and other on how trading partners can identify Security Act Implementation:
applicable disclosure law. For more such product and determine whether Identification of Suspect Product and
information about FDA’s posting of the product is a suspect product as soon Notification.’’ It does not establish any
comments to public dockets, see 80 FR as practicable. rights for any person and, with the
56469, September 18, 2015, or access Beginning January 1, 2015, section exception of section IV.B, is not binding
the information at http://www.fda.gov/ 582 of the FD&C Act required trading on FDA or the public. You can use an
regulatoryinformation/dockets/ partners, upon determining that a alternative approach if it satisfies the
default.htm. product in their possession or control is requirements of the applicable statutes
Docket: For access to the docket to illegitimate, to notify: (1) FDA and (2) and regulations.
read background documents or the all immediate trading partners that they
have reason to believe may have II. Electronic Access
electronic and written/paper comments
received, go to https:// received the illegitimate product, not Persons with access to the Internet
www.regulations.gov and insert the later than 24 hours after making the may obtain the guidance at http://
docket number, found in brackets in the determination. Manufacturers are www.fda.gov/Drugs/Guidance
heading of this document, into the additionally required under section ComplianceRegulatoryInformation/
‘‘Search’’ box, and follow the prompts; 582(b)(4)(B)(ii)(II) of the FD&C Act to Guidances/default.htm, http://
and/or go to the Division of Dockets notify FDA and any immediate trading www.fda.gov/BiologicsBloodVaccines/
Management, 5630 Fishers Lane, Rm. partners that the manufacturer has GuidanceComplianceRegulatory
1061, Rockville, MD 20852. reason to believe may possess a product Information/Guidances/default.htm, or
Submit written requests for single manufactured by (or purported to be https://www.regulations.gov.
copies of this guidance to the Division manufactured by) the manufacturer, not
later than 24 hours after the III. Paperwork Reduction Act of 1995
of Drug Information, Center for Drug
Evaluation and Research, Food and manufacturer determines or is notified This guidance contains information
Drug Administration, 10001 New by FDA or a trading partner that there collection provisions that are subject to
Hampshire Ave., Hillandale Bldg. 4th is a high risk that a product is review by the Office of Management and
Floor, Silver Spring, MD 20993–0002; or illegitimate. Section III.C of this Budget (OMB) under the Paperwork
the Office of Communication, Outreach guidance, entitled ‘‘For Manufacturers: Reduction Act of 1995 (44 U.S.C. 3501–
and Development, Center for Biologics High Risk of Illegitimacy Notification’’ 3520). The collection of information in
Evaluation and Research, Food and and highlighted in grey, describes this guidance was approved under OMB
Drug Administration, 10903 New notifications related to products that control number 0910–0806.
Hampshire Ave., Bldg. 71, Rm. 3128, pose a high risk of illegitimacy, and is Dated: December 5, 2016.
Silver Spring, MD 20993–0002. Send marked ‘‘for comment purposes only’’ to Leslie Kux,
one self-addressed adhesive label to provide an opportunity for comment
Associate Commissioner for Policy.
assist that office in processing your before it is finalized. The guidance also
[FR Doc. 2016–29588 Filed 12–8–16; 8:45 am]
requests. See the SUPPLEMENTARY addresses how trading partners should
notify FDA using Form FDA 3911. In BILLING CODE 4164–01–P
INFORMATION section for electronic
access to the guidance document. addition, in accordance with section
582(h)(2) of the FD&C Act, the guidance
FOR FURTHER INFORMATION CONTACT:
sets forth the process by which trading DEPARTMENT OF HEALTH AND
Office of Compliance, Center for Drug partners must terminate the HUMAN SERVICES
Evaluation and Research, Food and notifications using Form FDA 3911, in
Drug Administration, 10903 New Health Resources and Services
consultation with FDA, regarding Administration
Hampshire Ave., Silver Spring, MD illegitimate product and, for a
20993–0002, 301–796–3130, manufacturer, a product with a high risk Council on Graduate Medical
drugtrackandtrace@fda.hhs.gov. of illegitimacy, under section Education
SUPPLEMENTARY INFORMATION: 582(b)(4)(B), (c)(4)(B), (d)(4)(B), and
(e)(4)(B) of the FD&C Act. AGENCY: Health Resources and Services
I. Background Administration (HRSA), Department of
In the Federal Register of June 11,
FDA is announcing the availability of 2014 (79 FR 33564), FDA announced the Health and Human Services (HHS).
a guidance for industry entitled ‘‘Drug availability of a draft guidance entitled ACTION: Notice of charter renewal.
Supply Chain Security Act ‘‘Drug Supply Chain Security Act
Implementation: Identification of Implementation: Identification of SUMMARY: HHS is hereby giving notice
Suspect Product and Notification.’’ The Suspect Product and Notification.’’ FDA that the Council on Graduate Medical
guidance addresses provisions in the has carefully considered the comments Education (COGME) has been renewed.
FD&C Act, as amended by the DSCSA received and made the following The effective date of the renewed
(Pub. L. 113–54). Section 202 of the changes in response to the comments: charter is September 30, 2016.
DSCSA adds section 582(h)(2) to the Section C, ‘‘For Manufacturers: High FOR FURTHER INFORMATION CONTACT: Dr.
FD&C Act (21 U.S.C. 360eee–1(h)(2)), Risk of Illegitimacy Notifications,’’ on Kennita Carter, Senior Advisor and
which requires FDA to issue guidance to pgs. 8–11 of the guidance, is a new Designated Federal Official, Division of
mstockstill on DSK3G9T082PROD with NOTICES
aid certain trading partners section added in response to comments Medicine and Dentistry, HRSA, HHS,
(manufacturers, repackagers, wholesale and questions received. In addition, 15M116, 5600 Fishers Lane, Rockville,
distributors, and dispensers) in FDA made minor changes to the Form MD 20857. Phone: (301) 945–3505;
identifying a suspect product and FDA 3911 and to the instructions for email: kcarter@hrsa.gov.
terminating notifications. The guidance completing the form. SUPPLEMENTARY INFORMATION: COGME is
identifies specific scenarios that could This guidance is being issued authorized by section 762 (42 U.S.C.
significantly increase the risk of a consistent with FDA’s good guidance 294o) of the Public Health Service Act,
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Document Created: 2018-02-14 09:03:36
Document Modified: 2018-02-14 09:03:36
| 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 | You may submit either electronic or written comments on Agency guidances at any time. However, the portion of this guidance that describes when manufacturers should notify FDA if there is a high risk that a product is illegitimate, is being distributed for comment purposes only. To ensure that the Agency considers your comment on this draft section before it begins work on the final version of this section of the guidance, submit either electronic or written comments on this section by February 7, 2017. | |
| Contact | Office of Compliance, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-3130, [email protected] | |
| FR Citation | 81 FR 89112 |
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