82 FR 56033 - Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 226 (November 27, 2017)

Page Range		56033-56035
FR Document		2017-25457

The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a draft guidance for industry entitled ``Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier.'' This draft guidance specifies whether and under what circumstances packages and homogenous cases of product not labeled with a product identifier shall be exempted, as grandfathered, from certain requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act).

Federal Register, Volume 82 Issue 226 (Monday, November 27, 2017)

[Federal Register Volume 82, Number 226 (Monday, November 27, 2017)]
[Notices]
[Pages 56033-56035]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-25457]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-6526]


Grandfathering Policy for Packages and Homogenous Cases of 
Product Without a Product Identifier; Draft Guidance for Industry; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
announcing the availability of a draft guidance for industry entitled 
``Grandfathering Policy for Packages and Homogenous Cases of Product 
Without a Product Identifier.'' This draft guidance specifies whether 
and under what circumstances packages and homogenous cases of product 
not labeled with a product identifier shall be exempted, as 
grandfathered, from certain requirements of the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act).

DATES: Submit either electronic or written comments on the draft 
guidance by January 26, 2018 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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concerning the collection of information proposed in the draft guidance 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 January 26, 2018.

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

[[Page 56034]]

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-2017-D-6526 for ``Grandfathering Policy for Packages and Homogenous 
Cases of Product Without a Product Identifier; Draft Guidance for 
Industry.'' 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 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: Abha Kundi, 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]; or Stephen Ripley, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Grandfathering Policy for Packages and Homogenous Cases of 
Product Without a Product Identifier.'' 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 the DSCSA added section 582 to the FD&C 
Act, which established product tracing requirements for manufacturers, 
repackagers, wholesale distributors, and dispensers. The DSCSA phases 
in its requirements over a period of 10 years.
    A critical set of phased product tracing requirements outlined in 
section 582 of the FD&C Act (21 U.S.C. 360eee-1) relate to the product 
identifier. Among its provisions, section 582 requires that each 
package and homogenous case of product in the pharmaceutical 
distribution supply chain bear a product identifier that is encoded 
with the product's standardized numerical identifier, lot number, and 
expiration date by specific dates. Under the statute, manufacturers 
must begin affixing or imprinting a product identifier to each package 
and homogenous case of a product intended to be introduced into 
commerce no later than November 27, 2017. Repackagers are required to 
do the same no later than November 27, 2018.
    Sections 582(c)(2), (d)(2), and (e)(2)(A)(iii) of the FD&C Act 
restrict trading partners' ability to engage in transactions involving 
packages and homogenous cases of product that are not labeled with a 
product identifier after specific dates. Beginning November 27, 2018, 
repackagers may not engage in a transaction involving a package or 
homogenous case of a product that is not encoded with a product 
identifier. Similar restrictions go into effect for wholesale 
distributors and dispensers on November 27, 2019, and November 27, 
2020, respectively.
    Section 582(a)(5)(A) of the FD&C Act gives FDA authority to exempt 
packages and homogenous cases of product without a product identifier 
from the product tracing requirements discussed above. We are required 
to issue guidance that specifies whether and under what circumstances 
we will exercise this authority. The draft guidance addresses this 
requirement. As explained in the draft guidance, only packages and 
homogenous cases of product that are in the pharmaceutical distribution 
supply chain at the time of the effective date of the requirements of 
section 582 are eligible for an exemption under section 582(a)(5)(A).
    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 Agency's current thinking on the 
grandfathering policy for packages and homogenous cases of product 
without a product identifier. Guidance documents generally do 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. For this 
particular document, section 582 of the FD&C Act gives FDA authority to 
issue binding guidance specifying the circumstances under which 
packages and homogenous cases of product that are not labeled with a 
product identifier shall be exempted from the requirements of section 
582 of the FD&C Act. Thus, insofar as section IV of this

[[Page 56035]]

guidance specifies the circumstances under which packages and 
homogenous cases of product that are not labeled with a product 
identifier and that are in the pharmaceutical distribution supply chain 
at the time of the effective date of the requirements of section 582 of 
the FD&C Act shall be exempted from certain requirements of section 
582, it will have binding effect upon finalization.

II. Electronic Access

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

    Dated: November 20, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-25457 Filed 11-24-17; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 82, No. 226 / Monday, November 27, 2017 / Notices 56035

guidance specifies the circumstances DATES: Fax written comments on the electronic records and signatures: (1)
under which packages and homogenous collection of information by December § 11.10 specifies procedures and
cases of product that are not labeled 27, 2017. controls for persons who use closed
with a product identifier and that are in ADDRESSES: To ensure that comments on systems to create, modify, maintain, or
the pharmaceutical distribution supply the information collection are received, transmit electronic records; (2) § 11.30
chain at the time of the effective date of OMB recommends that written specifies procedures and controls for
the requirements of section 582 of the comments be faxed to the Office of persons who use open systems to create,
FD&C Act shall be exempted from Information and Regulatory Affairs, modify, maintain, or transmit electronic
certain requirements of section 582, it OMB, Attn: FDA Desk Officer, Fax: 202– records; (3) § 11.50 specifies procedures
will have binding effect upon 395–7285, or emailed to oira_ and controls for persons who use
finalization. submission@omb.eop.gov. All electronic signatures; and (4) § 11.300
comments should be identified with the specifies controls to ensure the security
II. Electronic Access
OMB control number 0910–0303. Also and integrity of electronic signatures
Persons with access to the internet include the FDA docket number found based upon use of identification codes
may obtain the guidance document at in brackets in the heading of this in combination with passwords. The
https://www.fda.gov/Drugs/Guidance document. reporting provision (§ 11.100) requires
ComplianceRegulatoryInformation/ persons to certify in writing to FDA that
FOR FURTHER INFORMATION CONTACT:
Guidances/default.htm, https://www. they will regard electronic signatures
Domini Bean, Office of Operations,
fda.gov/BiologicsBloodVaccines/ used in their systems as the legally
Food and Drug Administration, Three
GuidanceComplianceRegulatory binding equivalent of traditional
White Flint North, 10A–12M, 11601
Information/Guidances/default.htm, or handwritten signatures.
Landsdown St., North Bethesda, MD
https://www.regulations.gov. The burden created by the
20852, 301–796–7729, PRAStaff@
Dated: November 20, 2017. fda.hhs.gov. information collection provision of this
Leslie Kux, regulation is a one-time burden
SUPPLEMENTARY INFORMATION: In associated with the creation of standard
Associate Commissioner for Policy. compliance with 44 U.S.C. 3507, FDA operating procedures, validation, and
[FR Doc. 2017–25457 Filed 11–24–17; 8:45 am] has submitted the following proposed certification. The Agency anticipates the
BILLING CODE 4164–01–P collection of information to OMB for use of electronic media will
review and clearance. substantially reduce the paperwork
Electronic Records; Electronic burden associated with maintaining
DEPARTMENT OF HEALTH AND
Signatures FDA required records. The respondents
HUMAN SERVICES
are businesses and other for-profit
OMB Control Number 0910–0303— organizations, State or local
Food and Drug Administration
Extension governments, Federal Agencies, and
This information collection supports nonprofit institutions.
[Docket No. FDA–2011–N–0076]
FDA regulations; specifically, in part 11 In the Federal Register of June 19,
Agency Information Collection (21 CFR part 11), which sets forth 2017 (82 FR 27838), we published a 60-
Activities; Submission for Office of criteria for acceptance of electronic day notice requesting public comment
Management and Budget Review; records, electronic signatures, and on the proposed extension of this
Comment Request; Electronic handwritten signatures executed to collection of information. No comments
Signatures electronic records as equivalent to paper were received in response to the
records. Under these regulations, information collection topics solicited
AGENCY: Food and Drug Administration, records and reports may be submitted to in the notice. However, one comment
HHS. FDA electronically provided the Agency was received regarding a related Agency
ACTION: Notice. has stated its ability to accept the draft guidance entitled, ‘‘Use of
records electronically in an Agency- Electronic Records and Electronic
SUMMARY: The Food and Drug established public docket and that the Signatures in Clinical Investigations
Administration (FDA) is announcing other requirements of part 11 are met. Under 21 CFR part 11—Questions and
that a proposed collection of The recordkeeping provisions in part Answers,’’ and the comment has been
information has been submitted to the 11 (§§ 11.10, 11.30, 11.50, and 11.300) directed to the appropriate Agency
Office of Management and Budget require the following standard operating components for consideration.
(OMB) for review and clearance under procedures to assure appropriate use of, We therefore estimate the burden of
the Paperwork Reduction Act of 1995. and precautions for, systems using this collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Average
Number of
Number of Total annual burden per
21 CFR section responses per Total hours
respondents responses response
respondent (in hours)
asabaliauskas on DSKBBXCHB2PROD with NOTICES

11.100 .................................................................................. 4,500 1 4,500 1 4,500
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

VerDate Sep<11>2014 16:59 Nov 24, 2017 Jkt 244001 PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 E:\FR\FM\27NON1.SGM 27NON1

Document Created: 2017-11-25 01:09:02
Document Modified: 2017-11-25 01:09:02

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 January 26, 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 January 26, 2018.
Contact		Abha Kundi, 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]; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240- 402-7911.
FR Citation		82 FR 56033

82 FR 56033 - Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 226 (November 27, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration