81 FR 96013 - Providing Regulatory Submissions in Electronic Format-Submission of Manufacturing Establishment Information; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 250 (December 29, 2016)

Page Range		96013-96015
FR Document		2016-31626

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Providing Regulatory Submissions in Electronic Format--Submission of Manufacturing Establishment Information.'' This guidance discusses the requirements for a valid electronic submission of manufacturing establishment information (MEI) under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This action will streamline the review of all manufacturing establishments involved in the preparation of a drug or biological product by consolidating information in one location and eliminating the inclusion of erroneous and/or outdated information from other Agency files.

Federal Register, Volume 81 Issue 250 (Thursday, December 29, 2016)

[Federal Register Volume 81, Number 250 (Thursday, December 29, 2016)]
[Notices]
[Pages 96013-96015]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2016-31626]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-1953]

Providing Regulatory Submissions in Electronic Format--Submission
of Manufacturing Establishment Information; Draft Guidance for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the availability of a draft guidance for industry entitled ``Providing
Regulatory Submissions in Electronic Format--Submission of
Manufacturing Establishment Information.'' This guidance discusses the
requirements for a valid electronic submission of manufacturing
establishment information (MEI) under the Federal Food, Drug, and
Cosmetic Act (the FD&C Act). This action will streamline the review of
all manufacturing establishments involved in the preparation of a drug
or biological product by consolidating information in one location and
eliminating the inclusion of erroneous and/or outdated information from
other Agency files.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), 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 on the draft
guidance by February 27, 2017.

ADDRESSES: You may submit comments as follows:

[[Page 96014]]

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-1953 for ``Providing Regulatory Submissions in Electronic
Format--Submission of Manufacturing Establishment Information.''
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 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 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. 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: Regarding drug products: Karen
Takahashi, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 4244, Silver
Spring, MD 20993-0002, 301-796-3191.
Regarding biological products: Stephen Ripley, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240-402-
7911.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a draft guidance for industry
entitled ``Providing Regulatory Submissions in Electronic Format--
Submission of Manufacturing Establishment Information.''
This draft guidance discusses the requirements and implementation
of section 745A(a) of the FD&C Act (21 U.S.C. 379k-1) regarding valid
electronic submissions of MEI. Twenty-four months after this draft has
been finalized, MEI contained in new drug applications (NDAs),
abbreviated new drug applications (ANDAs), biologics license
applications (BLAs), and amendments, supplements, or resubmissions of
these application types must be submitted electronically in the format
specified in this guidance. This draft guidance also applies to drug
master files that are submitted for incorporation by reference into an
NDA, ANDA, or BLA.
Under current regulations at 21 CFR 314.50(d) and 21 CFR 601.2(a),
applicants and holders of approved applications are required to submit
contact information for each manufacturing establishment involved in
the manufacture of the drug or biological product, as well as other
information relating to the manufacture of the product. This
information is part of the existing application form (FDA Form 356h,
``Application to Market a New Drug, Biologic, or an Antibiotic Drug for
Human Use''). We have found that the MEI is sometimes incomplete, and
scattered throughout electronic submissions. This can lead to delays in
application processing.
The Agency is requiring that applicants submit a single,
consolidated list of information about each manufacturing establishment
mentioned in any application. This information must include the name
and address of each manufacturing establishment involved in the
manufacture of the drug or biological product, specific information
regarding the physical location of the establishment, facility
identifiers assigned to the establishment by FDA, contact information
for the person responsible for scheduling inspections at the
establishment, and

[[Page 96015]]

the specific manufacturing operations conducted at the establishment.
We believe the required electronic MEI can be consolidated to
appear in a single location to facilitate the complete, timely, and
accurate review of all manufacturing establishments involved in the
preparation of a drug or biological product. This will help to
eliminate the inclusion and/or maintenance of potentially outdated and
erroneous information that could be retrieved from other Agency files
and will enable proper identification and timely evaluation of
manufacturing establishments for conformance with requirements,
including current good manufacturing practices.

II. Paperwork Reduction Act of 1995

The guidance refers to previously approved collections of
information 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 draft guidance discusses the electronic submission of MEI
contained in an NDA, ANDA, or BLA to the Center for Drug Evaluation and
Research and the Center for Biologics Evaluation and Research by
specifying the format for the electronic submission of such
submissions. The information collection discussed in the guidance is
contained in our NDA and ANDA regulations (part 314) and approved under
OMB control number 0910-0001, and our BLA regulations (part 601) and
approved under OMB control number 0910-0338. Currently, MEI is
submitted as part of the existing application form, Form FDA 356h, and
is approved by OMB under control number 0910-0338.

III. Electronic Access

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

Dated: December 23, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-31626 Filed 12-28-16; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 250 / Thursday, December 29, 2016 / Notices 96013

comparable approved radiopharmaceutical has a change that A compounder also maintains records
radiopharmaceutical that produces for produces a clinical difference for an of prescriptions or orders noting the
an identified individual patient a identified individual patient as determination that a prescriber has
clinical difference, the determination is compared to the comparable approved determined that the compounded
documented on the prescription or radiopharmaceutical. We estimate that radiopharmaceutical has a change that
order in writing by either (1) the compounders will document this produces a clinical difference for an
prescribing practitioner, or (2) the determination on approximately 250 identified individual patient. We
compounder, reflecting a conversation prescriptions or orders for compounded estimate that the compounder will take
with the prescribing practitioner. The radiopharmaceuticals ‘‘Total Annual approximately 2.1 hours to maintain the
compounder maintains records of the Disclosures’’ in table 1, line 1). We records of 250 prescriptions or orders
prescription or order documenting this estimate that the consultation between documenting the prescriber’s
determination. the compounder and the prescriber and determination of clinical difference
We estimate that annually a total of (‘‘Total Hours’’ in table 2). We estimate
noting this determination on each
approximately 10 compounders (‘‘No. of that maintaining such records will take
prescription or order that does not
Respondents’’ in table 1, line 1) will approximately 30 seconds per
consult a prescriber to determine already document this determination prescription or order.
whether he or she has made a will take approximately 3 minutes per FDA estimates the burden of this
determination that the compounded prescription or order. collection of information as follows:
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of Average
Number of disclosures Total annual
Type of reporting burden per Total hours
respondents per disclosures disclosure
respondent

Consultation between the compounder and prescriber or 10 25 250 3 minutes .... 12.5
health care facility, and the notation on the prescription or
order documenting the prescriber’s determination of clin-
ical difference.
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Average
Number of burden
Number of Total annual
Type of reporting records per per Total hours
recordkeepers records
recordkeeper record-
keeping

Maintenance of records of prescriptions or orders docu- 10 25 250 30 seconds .. 2.1
menting the prescriber’s determination of clinical dif-
ference.
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

III. Electronic Access DEPARTMENT OF HEALTH AND submission of manufacturing
HUMAN SERVICES establishment information (MEI) under
Persons with access to the Internet the Federal Food, Drug, and Cosmetic
may obtain the draft guidance at either Food and Drug Administration Act (the FD&C Act). This action will
http://www.fda.gov/Drugs/Guidance streamline the review of all
[Docket No. FDA–2014–D–1953]
ComplianceRegulatoryInformation/ manufacturing establishments involved
Guidances/default.htm or https:// Providing Regulatory Submissions in in the preparation of a drug or biological
www.regulations.gov. Electronic Format—Submission of product by consolidating information in
Dated: December 22, 2016. Manufacturing Establishment one location and eliminating the
Leslie Kux,
Information; Draft Guidance for inclusion of erroneous and/or outdated
Industry; Availability information from other Agency files.
Associate Commissioner for Policy.
[FR Doc. 2016–31513 Filed 12–28–16; 8:45 am] AGENCY: Food and Drug Administration, DATES: Although you can comment on
BILLING CODE 4164–01–P
HHS. any guidance at any time (see 21 CFR
ACTION: Notice of availability. 10.115(g)(5)), to ensure that the Agency
SUMMARY: The Food and Drug considers your comment on this draft
asabaliauskas on DSK3SPTVN1PROD with NOTICES

Administration (FDA or Agency) is guidance before it begins work on the
announcing the availability of a draft final version of the guidance, submit
guidance for industry entitled either electronic or written comments
‘‘Providing Regulatory Submissions in on the draft guidance by February 27,
Electronic Format—Submission of 2017.
Manufacturing Establishment
Information.’’ This guidance discusses ADDRESSES: You may submit comments
the requirements for a valid electronic as follows:

VerDate Sep<11>2014 18:41 Dec 28, 2016 Jkt 241001 PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 E:\FR\FM\29DEN1.SGM 29DEN1

Federal Register / Vol. 81, No. 250 / Thursday, December 29, 2016 / Notices 96015

the specific manufacturing operations DEPARTMENT OF HEALTH AND Drug, and Cosmetic Act (21 U.S.C.
conducted at the establishment. HUMAN SERVICES 342(a)(1) and (4)).
Certain provisions in part 123 require
We believe the required electronic
Food and Drug Administration that processors and importers of seafood
MEI can be consolidated to appear in a
[Docket No. FDA–2013–N–0879]
collect and record information. The
single location to facilitate the complete, HACCP records compiled and
timely, and accurate review of all maintained by a seafood processor
manufacturing establishments involved Agency Information Collection
Activities; Submission for Office of primarily consist of the periodic
in the preparation of a drug or biological observations recorded at selected
Management and Budget Review;
product. This will help to eliminate the monitoring points during processing
Comment Request; Procedures for the
inclusion and/or maintenance of Safe and Sanitary Processing and and packaging operations, as called for
potentially outdated and erroneous Importing of Fish and Fishery Products in a processor’s HACCP plan (e.g., the
information that could be retrieved from values for processing times,
other Agency files and will enable AGENCY: Food and Drug Administration, temperatures, acidity, etc., as observed
proper identification and timely HHS. at critical control points). The primary
evaluation of manufacturing ACTION: Notice. purpose of HACCP records is to permit
establishments for conformance with a processor to verify that products have
SUMMARY: The Food and Drug been produced within carefully
requirements, including current good Administration (FDA) is announcing
manufacturing practices. established processing parameters
that a proposed collection of (critical limits) that ensure that hazards
II. Paperwork Reduction Act of 1995 information has been submitted to the have been avoided.
Office of Management and Budget HACCP records are normally
The guidance refers to previously (OMB) for review and clearance under reviewed by appropriately trained
approved collections of information that the Paperwork Reduction Act of 1995. employees at the end of a production lot
are subject to review by the Office of DATES: Fax written comments on the or at the end of a day or week of
Management and Budget (OMB) under collection of information by January 30, production to verify that control limits
the Paperwork Reduction Act of 1995 2017. have been maintained, or that
(44 U.S.C. 3501–3520). The draft ADDRESSES: To ensure that comments on appropriate corrective actions were
guidance discusses the electronic the information collection are received, taken if the critical limits were not
submission of MEI contained in an OMB recommends that written maintained. Such verification activities
NDA, ANDA, or BLA to the Center for comments be faxed to the Office of are essential to ensure that the HACCP
Drug Evaluation and Research and the Information and Regulatory Affairs, system is working as planned. A review
Center for Biologics Evaluation and OMB, Attn: FDA Desk Officer, FAX: of these records during the conduct of
Research by specifying the format for 202–395–7285, or emailed to oira_ periodic plant inspections also permits
the electronic submission of such submission@omb.eop.gov. All FDA to determine whether the products
submissions. The information collection comments should be identified with the have been consistently processed in
discussed in the guidance is contained OMB control number 0910–0354. Also conformance with appropriate HACCP
in our NDA and ANDA regulations (part include the FDA docket number found food safety controls.
in brackets in the heading of this Section 123.12 requires that importers
314) and approved under OMB control
document. of seafood products take affirmative
number 0910–0001, and our BLA steps and maintain records that verify
regulations (part 601) and approved FOR FURTHER INFORMATION CONTACT: FDA
that the fish and fishery products they
under OMB control number 0910–0338. PRA Staff, Office of Operations, Food
offer for import into the United States
Currently, MEI is submitted as part of and Drug Administration, Three White
were processed in accordance with the
the existing application form, Form FDA Flint North, 10A63, 11601 Landsdown HACCP and sanitation provisions set
356h, and is approved by OMB under St., North Bethesda, MD 20852, forth in part 123. These records are also
control number 0910–0338. PRAStaff@fda.hhs.gov. to be made available for review by FDA
SUPPLEMENTARY INFORMATION: In as provided in § 123.12(c).
III. Electronic Access compliance with 44 U.S.C. 3507, FDA The time and costs of these
has submitted the following proposed recordkeeping activities will vary
Persons with access to the Internet
collection of information to OMB for considerably among processors and
may obtain the document at http://
review and clearance. importers of fish and fishery products,
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/ Procedures for the Safe and Sanitary depending on the type and number of
Guidances/default.htm, http:// Processing and Importing of Fish and products involved, and on the nature of
Fishery Products—21 CFR part 123 the equipment or instruments required
www.fda.gov/BiologicsBloodVaccines/
to monitor critical control points. The
GuidanceComplianceRegulatory OMB Control Number 0910–0354— burden estimate in table 1 includes only
Information/default.htm, or https:// Extension those collections of information under
www.regulations.gov. FDA regulations in part 123 (21 CFR the seafood HACCP regulations that are
Dated: December 23, 2016. part 123) mandate the application of not already required under other
hazard analysis and critical control statutes and regulations. The estimate
asabaliauskas on DSK3SPTVN1PROD with NOTICES

Leslie Kux,
Associate Commissioner for Policy. point (HACCP) principles to the also does not include collections of
[FR Doc. 2016–31626 Filed 12–28–16; 8:45 am]
processing of seafood. HACCP is a information that are a usual and
preventive system of hazard control customary part of businesses’ normal
BILLING CODE 4164–01–P
designed to help ensure the safety of activities. For example, the tagging and
foods. The regulations were issued labeling of molluscan shellfish (21 CFR
under FDA’s statutory authority to 1240.60) is a customary and usual
regulate food safety, including section practice among seafood processors.
402(a)(1) and (4) of the Federal Food, Consequently, the estimates in table 1

VerDate Sep<11>2014 18:41 Dec 28, 2016 Jkt 241001 PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 E:\FR\FM\29DEN1.SGM 29DEN1

Document Created: 2016-12-29 01:58:46
Document Modified: 2016-12-29 01:58:46

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		Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), 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 on the draft guidance by February 27, 2017.
Contact		Regarding drug products: Karen Takahashi, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 4244, Silver Spring, MD 20993-0002, 301-796-3191.
FR Citation		81 FR 96013

81 FR 96013 - Providing Regulatory Submissions in Electronic Format-Submission of Manufacturing Establishment Information; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 250 (December 29, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration