83_FR_47809 83 FR 47626 - Product Identifiers Under the Drug Supply Chain Security Act Questions and Answers; Draft Guidance for Industry; Availability

83 FR 47626 - Product Identifiers Under the Drug Supply Chain Security Act Questions and Answers; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 183 (September 20, 2018)

Page Range47626-47628
FR Document2018-20502

The Food and Drug Administration FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Product Identifiers Under the Drug Supply Chain Security Act Questions and Answers.'' This draft guidance intends to clarify questions relating to product identifiers that are required by the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Drug Supply Chain Security Act (DSCSA) for packages and homogenous cases of certain drug products. Sections of the FD&C Act require manufacturers and repackagers to affix or imprint a product identifier to each package and homogenous case of a product intended to be introduced in a transaction into commerce beginning November 27, 2017, and November 28, 2018, respectively. This draft guidance intends to clarify these requirements.

Federal Register, Volume 83 Issue 183 (Thursday, September 20, 2018) 
[Federal Register Volume 83, Number 183 (Thursday, September 20, 2018)]
[Notices]
[Pages 47626-47628]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-20502]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-3175]


Product Identifiers Under the Drug Supply Chain Security Act 
Questions and Answers; Draft Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``Product 
Identifiers Under the Drug Supply Chain Security Act Questions and 
Answers.'' This draft guidance intends to clarify questions relating to 
product identifiers that are required by the Federal Food, Drug, and 
Cosmetic Act

[[Page 47627]]

(FD&C Act), as amended by the Drug Supply Chain Security Act (DSCSA) 
for packages and homogenous cases of certain drug products. Sections of 
the FD&C Act require manufacturers and repackagers to affix or imprint 
a product identifier to each package and homogenous case of a product 
intended to be introduced in a transaction into commerce beginning 
November 27, 2017, and November 28, 2018, respectively. This draft 
guidance intends to clarify these requirements.

DATES: Submit either electronic or written comments on the draft 
guidance by November 19, 2018 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance. Submit either electronic or written comments 
concerning the collection of information proposed in the draft guidance 
by November 19, 2018.

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): 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-3175 for ``Product Identifiers Under the Drug Supply Chain 
Security Act Questions and Answers.'' Received comments will be placed 
in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through 
Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the 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: Tia Harper-Velazquez, 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

    The DSCSA (Title II of Pub. L. 113-54) was signed into law on 
November 27, 2013. Section 202 of the DSCSA added section 582 to the 
FD&C Act (21 U.S.C. 360eee-1). This section establishes product 
tracing, product identifier, and verification requirements for 
manufacturers, repackagers, wholesale distributors, and dispensers to 
facilitate the tracing of products through the pharmaceutical 
distribution supply chain. Failure to comply with the requirements of 
section 582 is a prohibited act under section 301(t) of the FD&C Act 
(21 U.S.C. 331(t)).
    The effective date for manufacturers to ``affix or imprint a 
product identifier to each package and homogenous case of a product 
intended to be introduced in a transaction into commerce'' under 
section 582(b)(2)(A) of the FD&C Act, is not later than November 27, 
2017. In June 2017, FDA published a draft guidance entitled ``Product 
Identifier Requirements Under the Drug Supply Chain Security Act--
Compliance Policy,'' in which FDA describes its intention regarding the 
enforcement of certain product identifiers under the DSCSA. As 
described in the draft guidance, FDA does not intend to take action 
against manufacturers who do not affix or imprint a product identifier 
to each package and homogenous case of products intended to be 
introduced in a transaction into commerce before November 26, 2018. 
This represents a 1-year delay in enforcement of the requirement for 
manufacturers to affix or imprint product identifiers. The

[[Page 47628]]

effective date for repackagers to ``affix or imprint a product 
identifier to each package and homogenous case of a product intended to 
be introduced in a transaction in commerce'' under section 582(e)(2)(A) 
of the FD&C Act, is not later than November 27, 2018.
    This guidance is intended to assist manufacturers and repackagers 
in understanding the requirements to affix or imprint a product 
identifier on each package and homogenous case of product that they 
introduce in a transaction into commerce to satisfy the product 
identifier requirement of section 582 of the FD&C Act. The 
recommendations in this guidance are intended to assist manufacturers 
and repackagers in standardizing both the human-readable and machine-
readable format of the information that is contained in the product 
identifier. This guidance also intends to clarify that these 
requirements do not change the linear barcode requirements.
    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 ``Product 
Identifiers Under the Supply Chain Security Act Questions and 
Answers.'' It does not establish any rights for any person and is not 
binding on FDA or the public. You can use an alternative approach if it 
satisfies the requirements of the applicable statutes and regulations. 
This guidance is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This draft guidance includes information collection provisions that 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520) 
(PRA). In accordance with the PRA, prior to publication of any final 
guidance document, FDA intends to solicit public comment and obtain OMB 
approval for any information collections recommended in this guidance 
that are new or that would represent material modifications to those 
previously approved collections of information found in FDA regulations 
or guidances.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or 
https://www.regulations.gov.

    Dated: September 14, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-20502 Filed 9-19-18; 8:45 am]
 BILLING CODE 4164-01-P

47626 Federal Register / Vol. 83, No. 183 / Thursday, September 20, 2018 / Notices except in accordance with 21 CFR 10.20 section 582 of the FD&C Act requires product purchased from repackagers and other applicable disclosure law. For that each package and homogenous case after November 27, 2018, is affixed or more information about FDA’s posting of product in the pharmaceutical imprinted with a product identifier. of comments to public dockets, see 80 distribution supply chain bear a product Finally, FDA removed the FR 56469, September 18, 2015, or access identifier that is encoded with the recommendations in the draft version of the information at: https://www.gpo.gov/ product’s standardized numerical this guidance related to the fdsys/pkg/FR-2015-09-18/pdf/2015- identifier, lot number, and expiration documentation for determining when a 23389.pdf. date by specific dates. Under the statute, product without a product identifier Docket: For access to the docket to manufacturers were required to begin was introduced in a transaction into read background documents or the affixing or imprinting a product commerce by a manufacturer. The topic electronic and written/paper comments identifier to each package and of documentation is addressed in the received, go to https:// homogenous case of a product intended final grandfathering policy guidance. www.regulations.gov and insert the to be introduced into commerce no later This guidance is being issued docket number, found in brackets in the than November 27, 2017. Failure to consistent with FDA’s good guidance heading of this document, into the comply with this and other practices regulation (21 CFR 10.115). ‘‘Search’’ box and follow the prompts requirements of section 582 is The guidance represents the current and/or go to the Dockets Management prohibited under section 301(t) of the thinking of FDA on ‘‘Product Identifier Staff, 5630 Fishers Lane, Rm. 1061, FD&C Act (21 U.S.C. 331(t)) and subject Requirements Under the Drug Supply Rockville, MD 20852. You may submit to enforcement action under the FD&C Chain Security Act—Compliance comments on any guidance at any time Act. Policy.’’ It does not establish any rights (see 21 CFR 10.115(g)(5)). In the Federal Register of July 3, 2017 for any person and is not binding on Submit written requests for single (82 FR 30868), FDA issued a notice FDA or the public. You can use an copies of the draft guidance to the announcing the availability of the draft alternative approach if it satisfies the Division of Drug Information, Center for version of this guidance. As described requirements of the applicable statutes Drug Evaluation and Research, Food in the guidance, in the years since the and regulations. This guidance is not and Drug Administration, 10001 New passage of DSCSA, FDA had received subject to Executive Order 12866. Hampshire Ave., Hillandale Building, comments and feedback from II. Electronic Access 4th Floor, Silver Spring, MD 20993– manufacturers and other trading 0002, or the Office of Communication, partners expressing concern with Persons with access to the internet Outreach and Development, Center for industry-wide readiness for may obtain the guidance at https:// Biologics Evaluation and Research, implementation of the DSCSA provision www.fda.gov/Drugs/Guidance Food and Drug Administration, 10903 requiring manufacturers to begin putting ComplianceRegulatoryInformation/ New Hampshire Ave., Building 71, Rm. product identifiers on their products by Guidances/default.htm, https:// 3128, Silver Spring, MD 20993–0002. November 27, 2017. Given the www.fda.gov/BiologicsBloodVaccines/ Send one self-addressed adhesive label implementation challenges that industry GuidanceComplianceRegulatory to assist that office in processing your has encountered, FDA recognized that Information/Guidances/default.htm, or requests. See the SUPPLEMENTARY some manufacturers would need https://www.regulations.gov. INFORMATION section for electronic additional time beyond November 27, Dated: September 14, 2018. access to the draft guidance document. 2017, to ensure that their products bear Leslie Kux, a product identifier as required by the Associate Commissioner for Policy. FOR FURTHER INFORMATION CONTACT: DSCSA. To minimize possible Connie Jung, Office of Compliance, [FR Doc. 2018–20444 Filed 9–19–18; 8:45 am] disruptions in the distribution of Center for Drug Evaluation and BILLING CODE 4164–01–P prescription drugs in the United States, Research, Food and Drug FDA does not intend to take action Administration, 10903 New Hampshire against manufacturers who do not affix DEPARTMENT OF HEALTH AND Ave., Silver Spring, MD 20993–0002, or imprint a product identifier to 301–796–3130, drugtrackandtrace@ HUMAN SERVICES packages or homogenous cases of fda.hhs.gov. product that are packaged before Food and Drug Administration SUPPLEMENTARY INFORMATION: November 27, 2018. This includes packages and homogenous cases of [Docket No. FDA–2018–D–3175] I. Background product that are packaged by a FDA is announcing the availability of Product Identifiers Under the Drug manufacturer on or after November 27, a guidance for industry entitled Supply Chain Security Act Questions 2017. The comment period for the draft ‘‘Product Identifier Requirements Under and Answers; Draft Guidance for guidance ended September 1, 2017. the Drug Supply Chain Security Act— Industry; Availability FDA received 19 comments on the draft Compliance Policy.’’ On November 27, guidance. AGENCY: Food and Drug Administration, 2013, the DSCSA (Title II of Pub. L. FDA made several changes to the HHS. 113–54) was signed into law. Section guidance. We streamlined the guidance ACTION: Notice of availability. 202 of the DSCSA added section 582 to to remove information that is portions of the Federal Food, Drug, and Cosmetic the draft version of this guidance SUMMARY: The Food and Drug Act (FD&C Act) (21 U.S.C. 360eee–1) because they were repetitive of the Administration FDA or Agency) is which established product tracing, information in the final guidance for announcing the availability of a draft amozie on DSK3GDR082PROD with NOTICES1 product identifier, authorized trading industry entitled, ‘‘Grandfathering guidance for industry entitled ‘‘Product partner and verification requirements Policy for Packages and Homogenous Identifiers Under the Drug Supply for manufacturers, repackagers, Cases of Product Without a Product Chain Security Act Questions and wholesale distributors, and dispensers Identifier.’’ In addition, FDA removed Answers.’’ This draft guidance intends to facilitate the tracing of products the language in the draft version of this to clarify questions relating to product through the pharmaceutical distribution guidance on wholesale distributor and identifiers that are required by the supply chain. Among its provisions, dispenser responsibilities to ensure Federal Food, Drug, and Cosmetic Act VerDate Sep<11>2014 18:01 Sep 19, 2018 Jkt 244001 PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 E:\FR\FM\20SEN1.SGM 20SEN1

Federal Register / Vol. 83, No. 183 / Thursday, September 20, 2018 / Notices 47627 (FD&C Act), as amended by the Drug Staff, FDA will post your comment, as Division of Drug Information, Center for Supply Chain Security Act (DSCSA) for well as any attachments, except for Drug Evaluation and Research, Food packages and homogenous cases of information submitted, marked, and and Drug Administration, 10001 New certain drug products. Sections of the identified, as confidential, if submitted Hampshire Ave., Hillandale Building, FD&C Act require manufacturers and as detailed in ‘‘Instructions.’’ 4th Floor, Silver Spring, MD 20993– repackagers to affix or imprint a product Instructions: All submissions received 0002; or to the Office of identifier to each package and must include the Docket No. FDA– Communication, Outreach and homogenous case of a product intended 2018–D–3175 for ‘‘Product Identifiers Development, Center for Biologics to be introduced in a transaction into Under the Drug Supply Chain Security Evaluation and Research, Food and commerce beginning November 27, Act Questions and Answers.’’ Received Drug Administration, 10903 New 2017, and November 28, 2018, comments will be placed in the docket Hampshire Ave., Bldg. 71, Rm. 3128, respectively. This draft guidance and, except for those submitted as Silver Spring, MD 20993–0002. Send intends to clarify these requirements. ‘‘Confidential Submissions,’’ publicly one self-addressed adhesive label to DATES: Submit either electronic or viewable at https://www.regulations.gov assist that office in processing your written comments on the draft guidance or at the Dockets Management Staff requests. See the SUPPLEMENTARY by November 19, 2018 to ensure that the between 9 a.m. and 4 p.m., Monday INFORMATION section for electronic Agency considers your comment on this through Friday. access to the draft guidance document. • Confidential Submissions—To draft guidance before it begins work on FOR FURTHER INFORMATION CONTACT: Tia submit a comment with confidential the final version of the guidance. Harper-Velazquez, Office of information that you do not wish to be Submit either electronic or written Compliance, Center for Drug Evaluation made publicly available, submit your comments concerning the collection of and Research, Food and Drug comments only as a written/paper information proposed in the draft Administration, 10903 New Hampshire submission. You should submit two guidance by November 19, 2018. Ave., Silver Spring, MD 20993–0002, copies total. One copy will include the ADDRESSES: You may submit comments information you claim to be confidential 301–796–3130, as follows: with a heading or cover note that states CDERBarcodeQuestions@fda.hhs.gov. ‘‘THIS DOCUMENT CONTAINS SUPPLEMENTARY INFORMATION: Electronic Submissions CONFIDENTIAL INFORMATION.’’ The I. Background Submit electronic comments in the Agency will review this copy, including following way: the claimed confidential information, in The DSCSA (Title II of Pub. L. 113– • Federal eRulemaking Portal: its consideration of comments. The 54) was signed into law on November https://www.regulations.gov. Follow the second copy, which will have the 27, 2013. Section 202 of the DSCSA instructions for submitting comments. claimed confidential information added section 582 to the FD&C Act (21 Comments submitted electronically, redacted/blacked out, will be available U.S.C. 360eee–1). This section including attachments, to https:// for public viewing and posted on establishes product tracing, product www.regulations.gov will be posted to https://www.regulations.gov. Submit identifier, and verification requirements the docket unchanged. Because your both copies to the Dockets Management for manufacturers, repackagers, comment will be made public, you are Staff. If you do not wish your name and wholesale distributors, and dispensers solely responsible for ensuring that your contact information to be made publicly to facilitate the tracing of products comment does not include any available, you can provide this through the pharmaceutical distribution confidential information that you or a information on the cover sheet and not supply chain. Failure to comply with third party may not wish to be posted, in the body of your comments and you the requirements of section 582 is a such as medical information, your or must identify this information as prohibited act under section 301(t) of anyone else’s Social Security number, or ‘‘confidential.’’ Any information marked the FD&C Act (21 U.S.C. 331(t)). confidential business information, such as ‘‘confidential’’ will not be disclosed The effective date for manufacturers as a manufacturing process. Please note except in accordance with 21 CFR 10.20 to ‘‘affix or imprint a product identifier that if you include your name, contact and other applicable disclosure law. For to each package and homogenous case information, or other information that more information about FDA’s posting of a product intended to be introduced identifies you in the body of your of comments to public dockets, see 80 in a transaction into commerce’’ under comments, that information will be FR 56469, September 18, 2015, or access section 582(b)(2)(A) of the FD&C Act, is posted on https://www.regulations.gov. the information at: https://www.gpo.gov/ not later than November 27, 2017. In • If you want to submit a comment fdsys/pkg/FR-2015-09-18/pdf/2015- June 2017, FDA published a draft with confidential information that you 23389.pdf. guidance entitled ‘‘Product Identifier do not wish to be made available to the Docket: For access to the docket to Requirements Under the Drug Supply public, submit the comment as a read background documents or the Chain Security Act—Compliance written/paper submission and in the electronic and written/paper comments Policy,’’ in which FDA describes its manner detailed (see ‘‘Written/Paper received, go to https:// intention regarding the enforcement of Submissions’’ and ‘‘Instructions’’). www.regulations.gov and insert the certain product identifiers under the docket number, found in brackets in the DSCSA. As described in the draft Written/Paper Submissions guidance, FDA does not intend to take heading of this document, into the Submit written/paper submissions as ‘‘Search’’ box and follow the prompts action against manufacturers who do follows: and/or go to the Dockets Management not affix or imprint a product identifier amozie on DSK3GDR082PROD with NOTICES1 • Mail/Hand delivery/Courier (for Staff, 5630 Fishers Lane, Rm. 1061, to each package and homogenous case written/paper submissions): Dockets Rockville, MD 20852. of products intended to be introduced in Management Staff (HFA–305), Food and You may submit comments on any a transaction into commerce before Drug Administration, 5630 Fishers guidance at any time (see 21 CFR November 26, 2018. This represents a 1- Lane, Rm. 1061, Rockville, MD 20852. 10.115(g)(5)). year delay in enforcement of the • For written/paper comments Submit written requests for single requirement for manufacturers to affix submitted to the Dockets Management copies of the draft guidance to the or imprint product identifiers. The VerDate Sep<11>2014 18:01 Sep 19, 2018 Jkt 244001 PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 E:\FR\FM\20SEN1.SGM 20SEN1

47628 Federal Register / Vol. 83, No. 183 / Thursday, September 20, 2018 / Notices effective date for repackagers to ‘‘affix or Dated: September 14, 2018. grandfathered group health plans and imprint a product identifier to each Leslie Kux, health insurance issuers offering group package and homogenous case of a Associate Commissioner for Policy. or individual health insurance are product intended to be introduced in a [FR Doc. 2018–20502 Filed 9–19–18; 8:45 am] required to provide insurance coverage transaction in commerce’’ under section BILLING CODE 4164–01–P without cost-sharing (a co-payment, co- 582(e)(2)(A) of the FD&C Act, is not later insurance, or deductible) for preventive than November 27, 2018. services for plan years (i.e., policy years) DEPARTMENT OF HEALTH AND beginning on or after the date that is one This guidance is intended to assist HUMAN SERVICES year from the Secretary’s adoption of the manufacturers and repackagers in condition for screening. understanding the requirements to affix During the November meeting, the Health Resources and Services or imprint a product identifier on each Administration Meeting of the Advisory ACHDNC will hear from experts in the package and homogenous case of Committee on Heritable Disorders in field and discuss issues related to product that they introduce in a Newborns and Children newborn screening information, transaction into commerce to satisfy the education, training activities, and product identifier requirement of AGENCY: Health Resources and Services training resources. The ACHDNC will section 582 of the FD&C Act. The Administration (HRSA), Department of hear presentations on the use of recommendations in this guidance are Health and Human Services (HHS). genomic sequencing in newborn intended to assist manufacturers and ACTION: Notice. screening as well as the clinical setting repackagers in standardizing both the for both well and sick infants. The human-readable and machine-readable SUMMARY: The Advisory Committee on ACHDNC will also discuss the format of the information that is Heritable Disorders in Newborns and nomination of cerebrotendinous contained in the product identifier. This Children (ACHDNC) has scheduled a xanthomatosis (CTX) to the RUSP and guidance also intends to clarify that public meeting. Information about the vote on whether to move the these requirements do not change the ACHDNC, a roster of members, the nomination forward to evidence review. linear barcode requirements. meeting agenda, as well as past meeting Note that this vote is not on a proposed summaries is located on the ACHDNC addition of a condition to the RUSP. This draft guidance is being issued website at https://www.hrsa.gov/ Agenda items are subject to change as consistent with FDA’s good guidance advisory-committees/heritable- priorities dictate. Refer to the ACHDNC practices regulation (21 CFR 10.115). disorders/index.html. website for any updated information The draft guidance, when finalized, will DATES: November 1, 2018, 10:30 a.m.– concerning the meeting. Members of the represent the current thinking of FDA 5:30 p.m. ET and November 2, 2018, public will have the opportunity to on ‘‘Product Identifiers Under the 9:00 a.m.–3:00 p.m. ET. provide comments, which are part of the Supply Chain Security Act Questions official Committee record. To submit ADDRESSES: This meeting will be held in and Answers.’’ It does not establish any written comments or request time for an rights for any person and is not binding person and by webinar. Advanced registration is required. Please register oral comment at the meeting, please on FDA or the public. You can use an register online by 12:00 p.m. ET on online at http:// alternative approach if it satisfies the October 26, 2018, at http:// www.achdncmeetings.org/ by 12:00 p.m. requirements of the applicable statutes www.achdncmeetings.org. Oral ET on October 29, 2018. The address for and regulations. This guidance is not comments will be honored in the order the meeting is 5600 Fishers Lane, subject to Executive Order 12866. they are requested and may be limited Rockville, Maryland 20857. II. Paperwork Reduction Act of 1995 as time allows. Individuals associated FOR FURTHER INFORMATION CONTACT: Ann with groups or who plan to provide Ferrero, Maternal and Child Health This draft guidance includes comments on similar topics may be Bureau (MCHB), HRSA, 5600 Fishers information collection provisions that asked to combine their comments and Lane, Room 18N100C, Rockville, are subject to review by the Office of present them through a single Maryland 20857; 301–443–3999; or Management and Budget (OMB) under representative. No audiovisual AFerrero@hrsa.gov. the Paperwork Reduction Act (PRA) of presentations are permitted. Written SUPPLEMENTARY INFORMATION: The comments should identify the 1995 (44 U.S.C. 3501–3520) (PRA). In ACHDNC provides advice and individual’s name, address, email, accordance with the PRA, prior to recommendations to the Secretary of telephone number, professional or publication of any final guidance HHS (Secretary) on the development of organization affiliation, background or document, FDA intends to solicit public newborn screening activities, comment and obtain OMB approval for area of expertise (i.e., parent, family technologies, policies, guidelines, and member, researcher, clinician, public any information collections programs for effectively reducing recommended in this guidance that are health, etc.) and the topic/subject morbidity and mortality in newborns matter. new or that would represent material and children having, or at risk for, Individuals who plan to attend and modifications to those previously heritable disorders. In addition, need special assistance or another approved collections of information ACHDNC’s recommendations regarding reasonable accommodation should found in FDA regulations or guidances. inclusion of additional conditions for notify Ann Ferrero at the address and III. Electronic Access screening, following adoption by the phone number listed above at least 10 Secretary, are evidence-informed business days prior to the meeting. amozie on DSK3GDR082PROD with NOTICES1 Persons with access to the internet preventive health services provided for Since this meeting occurs in a federal may obtain the draft guidance at either in the comprehensive guidelines government building, attendees must go https://www.fda.gov/Drugs/ supported by HRSA through the through a security check to enter the GuidanceCompliance Recommended Uniform Screening Panel building. Non-U.S. Citizens attendees RegulatoryInformation/Guidances/ (RUSP) pursuant to section 2713 of the planning to attend must notify HRSA of default.htm or https:// Public Health Service Act (42 U.S.C. their planned attendance at least 10 www.regulations.gov. 300gg–13). Under this provision, non- business days prior to the meeting in VerDate Sep<11>2014 18:01 Sep 19, 2018 Jkt 244001 PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 E:\FR\FM\20SEN1.SGM 20SEN1


Document Created: 2018-09-20 02:09:27
Document Modified: 2018-09-20 02:09:27
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of availability.
DatesSubmit either electronic or written comments on the draft guidance by November 19, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. Submit either electronic or written comments concerning the collection of information proposed in the draft guidance by November 19, 2018.
ContactTia Harper-Velazquez, 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 Citation83 FR 47626 
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR