81 FR 10260 - Requirements for Transactions With First Responders Under Section 582 of the Federal Food, Drug, and Cosmetic Act-Compliance Policy; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 39 (February 29, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 39 (February 29, 2016)
| Page Range | 10260-10261 | |
| FR Document | 2016-04227 |
[Federal Register Volume 81, Number 39 (Monday, February 29, 2016)] [Notices] [Pages 10260-10261] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-04227] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-D-0631] Requirements for Transactions With First Responders Under Section 582 of the Federal Food, Drug, and Cosmetic Act--Compliance Policy; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled ``Requirements for Transactions with First Responders under Section 582 of the Federal Food, Drug, and Cosmetic Act--Compliance Policy.'' This guidance describes FDA's compliance policy regarding certain requirements in the Federal Food, Drug, and Cosmetic Act (the FD&C Act) for trading partners engaged in transactions with first responders. This compliance policy is in effect until further notice by FDA. DATES: Effective February 29, 2016. For information about enforcement dates, please see the SUPPLEMENTARY INFORMATION section. 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-0631 for ``Requirements for Transactions with First Responders under Section 582 of the Federal Food, Drug, and Cosmetic Act--Compliance Policy; Guidance for Industry.'' 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. [[Page 10261]] 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 this 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. 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 We are announcing the availability of a guidance for industry entitled ``Requirements for Transactions with First Responders under Section 582 of the Federal Food, Drug, and Cosmetic Act--Compliance Policy.'' We are issuing this guidance consistent with our good guidance practices regulation (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 (21 CFR 10.115(g)(2)). We made this determination because this guidance document provides information pertaining to compliance with certain statutory requirements described in this document that are currently in effect. In addition, because FDA's compliance policy regarding the provisions to provide, capture, and maintain product tracing information under section 582(d)(1) of the FD&C Act (21 U.S.C. 360eee- 1(d)(1)) will expire on March 1, 2016 (see 80 FR 67408, November 2, 2015), it is important that FDA provide this information before that date to avoid potential disruptions in the supply chain. Although this guidance document is immediately in effect, it remains subject to comment in accordance with the Agency's good guidance practices (21 CFR 10.115(g)(3)). FDA is particularly interested in comments related to the scope of this guidance. FDA will consider any comments received and may revise the scope of the enforcement policy described in this guidance as appropriate. On November 27, 2013, the Drug Supply Chain Security Act (DSCSA) (Title II of Pub. L. 113-54) was signed into law. Section 202 of DSCSA adds sections 581 and 582 to the FD&C Act (21 U.S.C. 360eee and 360eee- 1), which set forth new definitions and requirements for the tracing of products through the pharmaceutical distribution supply chain. Starting in 2015, certain trading partners (manufacturers, wholesale distributors, dispensers, and repackagers) generally were required under sections 582(b)(1), (c)(1), (d)(1), and (e)(1) of the FD&C Act to exchange product tracing information when engaging in transactions involving certain prescription drugs. These trading partners were also generally required under sections 582(b)(4), (c)(4), (d)(4) and (e)(4) to have systems in place to enable the verification of suspect and illegitimate product. Furthermore, sections 582(b)(3), (c)(3), (d)(3), and (e)(3) specify that the trading partners of manufacturers, wholesale distributors, dispensers, and repackagers must be ``authorized'' within the meaning of section 581(2) of the FD&C Act. For dispensers, requirements for the tracing of products through the pharmaceutical distribution supply chain under section 582(d)(1) of the FD&C Act took effect on July 1, 2015. FDA published a notice of availability for a revised guidance document on November 2, 2015, stating that it does not intend to take action against dispensers who, prior to March 1, 2016, accept ownership of product without receiving the product tracing information, as required by section 582(d)(1)(A)(i) of the FD&C Act, or do not capture and maintain the product tracing information, as required by section 582(d)(1)(A)(iii) of the FD&C Act (80 FR 67408). As described in the guidance, FDA understands that transactions between dispensers and first responders may present challenges related to compliance with certain requirements in section 582 of the FD&C Act related to the exchange of product tracing information, conducting business only with authorized trading partners, and having verification systems in place. To minimize possible disruptions to the activities of first responders, FDA does not intend to take action against certain trading partners and first responders as described in the guidance. This compliance policy is in effect until further notice by FDA. The 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. II. Electronic Access Persons with access to the Internet may obtain the guidance document at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or http://www.regulations.gov. Dated: February 23, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-04227 Filed 2-26-16; 8:45 am] BILLING CODE 4164-01-P
![10260 Federal Register / Vol. 81, No. 39 / Monday, February 29, 2016 / Notices
quality efforts. This event will also the FMDIC, Inc., to FMDIC Registrar, please see the SUPPLEMENTARY
focus on various topics of interest for 4447 N. Central Expressway, Suite 110 INFORMATION section.
those industry representatives who are PMB197, Dallas, TX 75205. FMDIC, Inc. ADDRESSES: You may submit comments
responsible to insure compliance with accepts registrations onsite on the day of as follows:
FDA regulations. the event beginning at 7:30 a.m. at the
DATES: The meeting will be held on regular registration fee stated above. Electronic Submissions
April 15, 2016, from 8 a.m. to 5 p.m. Registration on site will be accepted on Submit electronic comments in the
ADDRESSES: The meeting will be held at a space available basis on the day of the following way:
Courtyard and Towne Place Suites by public workshop beginning at 7:30 a.m. • Federal eRulemaking Portal: http://
Marriott, DFW Airport North/Grapevine, Please note that due to popularity, www.regulations.gov. Follow the
2200 Bass Pro Ct., Grapevine, TX 76051. similar past events have reached instructions for submitting comments.
Directions and lodging information are maximum capacity well before the day Comments submitted electronically,
available at the FMDIC, Inc. Web site at of the event. The cost of registration at including attachments, to http://
http://www.fmdic.org/. the site is $300 payable to the FMDIC, www.regulations.gov will be posted to
FOR FURTHER INFORMATION CONTACT:
Inc. The registration fee will be used to the docket unchanged. Because your
Staci McAllister, Consumer Safety offset expenses of hosting the event, comment will be made public, you are
Technician, Food and Drug including continental breakfast, lunch, solely responsible for ensuring that your
Administration, 4040 N. Central audiovisual equipment, venue, comment does not include any
Expressway, Suite 300, Dallas, TX materials, and other logistics associated confidential information that you or a
75204, 214–253–5259, FAX: 214–253– with this event. third party may not wish to be posted,
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due to a disability, please contact Staci anyone else’s Social Security number, or
SUPPLEMENTARY INFORMATION:
McAllister (see FOR FURTHER confidential business information, such
I. Background INFORMATION CONTACT) at least 7 days in as a manufacturing process. Please note
The workshop is being held in advance. that if you include your name, contact
response to the interest in the topics Transcripts: Transcripts of the public information, or other information that
discussed from small medical device workshop will not be available due to identifies you in the body of your
manufacturers in the Dallas District the format of this workshop. comments, that information will be
area. This workshop helps achieve Dated: February 23, 2016. posted on http://www.regulations.gov.
objectives set forth in section 406 of the Leslie Kux, • If you want to submit a comment
Food and Drug Administration Associate Commissioner for Policy. with confidential information that you
Modernization Act of 1997 (21 U.S.C. [FR Doc. 2016–04221 Filed 2–26–16; 8:45 am] do not wish to be made available to the
393), which include working closely BILLING CODE 4164–01–P
public, submit the comment as a
with stakeholders and maximizing the written/paper submission and in the
availability and clarity of information to manner detailed (see ‘‘Written/Paper
stakeholders and the public. This DEPARTMENT OF HEALTH AND Submissions’’ and ‘‘ Instructions’’).
workshop is also consistent with the HUMAN SERVICES Written/Paper Submissions
Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104–121) Food and Drug Administration Submit written/paper submissions as
as an outreach activity by Government follows:
[Docket No. FDA–2016–D–0631]
agencies to small businesses. • Mail/Hand delivery/Courier (for
The goal of the public workshop is to Requirements for Transactions With written/paper submissions): Division of
present information that will enable First Responders Under Section 582 of Dockets Management (HFA–305), Food
manufacturers and regulated industry to the Federal Food, Drug, and Cosmetic and Drug Administration, 5630 Fishers
better comply with FDA’s medical Act—Compliance Policy; Guidance for Lane, Rm. 1061, Rockville, MD 20852.
device requirements. Please visit the Industry; Availability • For written/paper comments
http://www.fmdic.org/ Web site for the submitted to the Division of Dockets
agenda and for information about the AGENCY: Food and Drug Administration, Management, FDA will post your
presenters at the workshop. HHS. comment, as well as any attachments,
ACTION: Notice of availability. except for information submitted,
II. Participation in the Public marked and identified, as confidential,
Workshop SUMMARY: The Food and Drug if submitted as detailed in
Registration: FMDIC has early Administration (FDA or we) is ‘‘Instructions.’’
registration ($250 for industry/$150 for announcing the availability of a Instructions: All submissions received
government with ID/$50 for students) guidance for industry entitled must include the Docket No. FDA–
available until March 14, 2016. ‘‘Requirements for Transactions with 2016–D–0631 for ‘‘Requirements for
Registration after March 14, 2016, First Responders under Section 582 of Transactions with First Responders
increases to $300 for industry, $200 for the Federal Food, Drug, and Cosmetic under Section 582 of the Federal Food,
government with ID, with student Act—Compliance Policy.’’ This Drug, and Cosmetic Act—Compliance
registration staying the same, at $50. To guidance describes FDA’s compliance Policy; Guidance for Industry.’’
asabaliauskas on DSK5VPTVN1PROD with NOTICES
register online, please visit http:// policy regarding certain requirements in Received comments will be placed in
www.fmdic.org/. As an alternative, send the Federal Food, Drug, and Cosmetic the docket and, except for those
the registration information including Act (the FD&C Act) for trading partners submitted as ‘‘Confidential
the registrant’s name, title, organization, engaged in transactions with first Submissions,’’ publicly viewable at
address, telephone and fax numbers, responders. This compliance policy is http://www.regulations.gov or at the
and email address (for each registrant), in effect until further notice by FDA. Division of Dockets Management
along with a check or money order DATES: Effective February 29, 2016. For between 9 a.m. and 4 p.m., Monday
(covering all registration fees) payable to information about enforcement dates, through Friday.
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![Federal Register / Vol. 81, No. 39 / Monday, February 29, 2016 / Notices 10261
• Confidential Submissions—To I. Background dispensers, and repackagers must be
submit a comment with confidential We are announcing the availability of ‘‘authorized’’ within the meaning of
information that you do not wish to be a guidance for industry entitled section 581(2) of the FD&C Act.
made publicly available, submit your ‘‘Requirements for Transactions with For dispensers, requirements for the
comments only as a written/paper First Responders under Section 582 of tracing of products through the
submission. You should submit two the Federal Food, Drug, and Cosmetic pharmaceutical distribution supply
copies total. One copy will include the Act—Compliance Policy.’’ We are
information you claim to be confidential chain under section 582(d)(1) of the
issuing this guidance consistent with FD&C Act took effect on July 1, 2015.
with a heading or cover note that states our good guidance practices regulation
‘‘THIS DOCUMENT CONTAINS FDA published a notice of availability
(21 CFR 10.115). We are implementing for a revised guidance document on
CONFIDENTIAL INFORMATION.’’ The this guidance without prior public
Agency will review this copy, including November 2, 2015, stating that it does
comment because we have determined not intend to take action against
the claimed confidential information, in that prior public participation is not
its consideration of comments. The dispensers who, prior to March 1, 2016,
feasible or appropriate (21 CFR
second copy, which will have the accept ownership of product without
10.115(g)(2)). We made this
claimed confidential information determination because this guidance receiving the product tracing
redacted/blacked out, will be available document provides information information, as required by section
for public viewing and posted on pertaining to compliance with certain 582(d)(1)(A)(i) of the FD&C Act, or do
http://www.regulations.gov. Submit statutory requirements described in this not capture and maintain the product
both copies to the Division of Dockets document that are currently in effect. In tracing information, as required by
Management. If you do not wish your addition, because FDA’s compliance section 582(d)(1)(A)(iii) of the FD&C Act
name and contact information to be policy regarding the provisions to (80 FR 67408).
made publicly available, you can provide, capture, and maintain product As described in the guidance, FDA
provide this information on the cover tracing information under section understands that transactions between
sheet and not in the body of your 582(d)(1) of the FD&C Act (21 U.S.C.
comments and you must identify this dispensers and first responders may
360eee–1(d)(1)) will expire on March 1, present challenges related to
information as ‘‘confidential.’’ Any 2016 (see 80 FR 67408, November 2,
information marked as ‘‘confidential’’ compliance with certain requirements
2015), it is important that FDA provide in section 582 of the FD&C Act related
will not be disclosed except in this information before that date to
accordance with 21 CFR 10.20 and other to the exchange of product tracing
avoid potential disruptions in the information, conducting business only
applicable disclosure law. For more supply chain. Although this guidance
information about FDA’s posting of with authorized trading partners, and
document is immediately in effect, it
comments to public dockets, see 80 FR having verification systems in place. To
remains subject to comment in
56469, September 18, 2015, or access minimize possible disruptions to the
accordance with the Agency’s good
the information at: http://www.fda.gov/ guidance practices (21 CFR activities of first responders, FDA does
regulatoryinformation/dockets/ 10.115(g)(3)). FDA is particularly not intend to take action against certain
default.htm. interested in comments related to the trading partners and first responders as
Docket: For access to the docket to scope of this guidance. FDA will described in the guidance. This
read background documents or the consider any comments received and compliance policy is in effect until
electronic and written/paper comments may revise the scope of the enforcement further notice by FDA.
received, go to http:// policy described in this guidance as The guidance represents the current
www.regulations.gov and insert the appropriate.
docket number, found in brackets in the thinking of FDA on this topic. It does
On November 27, 2013, the Drug not establish any rights for any person
heading of this document, into the Supply Chain Security Act (DSCSA)
‘‘Search’’ box and follow the prompts and is not binding on FDA or the public.
(Title II of Pub. L. 113–54) was signed You can use an alternative approach if
and/or go to the Division of Dockets into law. Section 202 of DSCSA adds
Management, 5630 Fishers Lane, Rm. it satisfies the requirements of the
sections 581 and 582 to the FD&C Act applicable statutes and regulations.
1061, Rockville, MD 20852. (21 U.S.C. 360eee and 360eee–1), which
Submit written requests for single set forth new definitions and II. Electronic Access
copies of this guidance to the Division requirements for the tracing of products
of Drug Information, Center for Drug through the pharmaceutical distribution Persons with access to the Internet
Evaluation and Research, Food and supply chain. Starting in 2015, certain may obtain the guidance document at
Drug Administration, 10001 New trading partners (manufacturers, http://www.fda.gov/Drugs/
Hampshire Ave., Hillandale Building, wholesale distributors, dispensers, and GuidanceCompliance
4th Floor, Silver Spring, MD 20993– repackagers) generally were required RegulatoryInformation/Guidances/
0002. Send one self-addressed adhesive under sections 582(b)(1), (c)(1), (d)(1), default.htm, http://www.fda.gov/
label to assist that office in processing and (e)(1) of the FD&C Act to exchange BiologicsBloodVaccines/
your requests. See the SUPPLEMENTARY product tracing information when GuidanceCompliance
INFORMATION section for electronic
engaging in transactions involving RegulatoryInformation/Guidances/
access to the guidance document. certain prescription drugs. These default.htm, or http://
asabaliauskas on DSK5VPTVN1PROD with NOTICES
FOR FURTHER INFORMATION CONTACT: trading partners were also generally www.regulations.gov.
Office of Compliance, Center for Drug required under sections 582(b)(4), (c)(4),
Evaluation and Research, Food and Dated: February 23, 2016.
(d)(4) and (e)(4) to have systems in place
Drug Administration, 10903 New to enable the verification of suspect and Leslie Kux,
Hampshire Ave., Silver Spring, MD illegitimate product. Furthermore, Associate Commissioner for Policy.
20993–0002, 301–796–3130, sections 582(b)(3), (c)(3), (d)(3), and [FR Doc. 2016–04227 Filed 2–26–16; 8:45 am]
drugtrackandtrace@fda.hhs.gov. (e)(3) specify that the trading partners of BILLING CODE 4164–01–P
SUPPLEMENTARY INFORMATION: manufacturers, wholesale distributors,
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Document Created: 2016-02-27 02:05:18
Document Modified: 2016-02-27 02:05:18
| 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 | Effective February 29, 2016. For information about enforcement dates, please see the SUPPLEMENTARY INFORMATION section. | |
| 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 10260 |
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