Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution, 37622-37625 [2015-16129]
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Federal Register / Vol. 80, No. 126 / Wednesday, July 1, 2015 / Notices
ANNUAL BURDEN ESTIMATES—Continued
Total Number
of Respondents
Instrument
Annual Number of Respondents
Number of Responses per
Respondent
Average Burden Hours per
Response
Annual Burden
Hours
Site visit semi-structured interview—program staff and
community partner organization staff ...............................
Site visit group discussion—program participants ...............
180
84
90
42
1
1
1.25
1.25
113
53
Estimated Total Annual Burden Hours .........................
........................
........................
........................
........................
178
In compliance with the requirements
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade SW., Washington, DC 20447,
Attn: OPRE Reports Clearance Officer.
Email address: OPREinfocollection@
acf.hhs.gov. All requests should be
identified by the title of the information
collection.
The Department specifically requests
comments on (a) whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Karl Koerper,
Reports Clearance Officer.
[FR Doc. 2015–16073 Filed 6–30–15; 8:45 am]
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BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Registration of Producers of Drugs and
Listing of Drugs in Commercial
Distribution—21 CFR Part 207
Food and Drug Administration
OMB Control Number 0910–0045—
Extension
[Docket No. FDA–2011–N–0742]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Registration of
Producers of Drugs and Listing of
Drugs in Commercial Distribution
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
SUMMARY:
Fax written comments on the
collection of information by July 31,
2015.
DATES:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0045. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
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Requirements for drug establishment
registration and drug listing are set forth
in section 510 of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act)
(21 U.S.C. 360), section 351 of the
Public Health Service Act (42 U.S.C.
262), and part 207 (21 CFR part 207).
Fundamental to FDA’s mission to
protect the public health is the
collection of this information, which is
used for important activities such as
postmarket surveillance for serious
adverse drug reactions, inspection of
drug manufacturing and processing
facilities, and monitoring of drug
products imported into the United
States. Comprehensive, accurate, and up
to date information is critical to
conducting these activities with
efficiency and effectiveness.
Under section 510 of the FD&C Act,
FDA is authorized to establish a system
for registration of producers of drugs
and for listing of drugs in commercial
distribution. To implement section 510
of the FD&C Act, FDA issued part 207.
Under current § 207.20, manufacturers,
repackers, and relabelers that engage in
the manufacture, preparation,
propagation, compounding, or
processing of human or veterinary drugs
and biological products, including bulk
drug substances and bulk drug
substances for prescription
compounding, and drug premixes as
well as finished dosage forms, whether
prescription or over-the-counter, are
required to register their establishment.
In addition, manufacturers, repackers,
and relabelers are required to submit a
listing of every drug or biological
product in commercial distribution.
Owners or operators of establishments
that distribute under their own label or
trade name a drug product
manufactured by a registered
establishment are not required either to
register or list. However, distributors
may elect to submit drug listing
information in lieu of the registered
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Federal Register / Vol. 80, No. 126 / Wednesday, July 1, 2015 / Notices
establishment that manufactures the
drug product. Foreign drug
establishments must also comply with
the establishment registration and
product listing requirements if they
import or offer for import their products
into the United States.
Under current § 207.21,
establishments, both domestic and
foreign, must register with FDA within
5 days after beginning the manufacture
of drugs or biologicals, or within 5 days
after the submission of a drug
application or biological license
application. In addition, establishments
must register annually. Changes in
individual ownership, corporate or
partnership structure, location, or drug
handling activity must be submitted as
amendments to registration under
current § 207.26 within 5 days of such
changes. Under § 207.20(b), private label
distributors may request their own
labeler code and elect to submit drug
listing information to FDA. In such
instances, at the time of submitting or
updating drug listing information,
private label distributors must certify to
the registered establishment that
manufactured, prepared, propagated,
compounded, or processed (which
includes, among other things,
repackaging and relabeling) the listed
drug that the drug listing submission
was made. Establishments must, within
5 days of beginning the manufacture of
drugs or biologicals, submit to FDA a
listing for every drug or biological
product in commercial distribution at
that time. Private label distributors may
elect to submit to FDA a listing of every
drug product they place in commercial
distribution. Registered establishments
must submit to FDA drug product
listing for those private label
distributors who do not elect to submit
listing information.
Under § 207.25, product listing
information submitted to FDA by
domestic and foreign manufacturers
must, depending on the type of product
being listed, include any new drug
application number or biological
establishment license number, copies of
current labeling and a sampling of
advertisements, a quantitative listing of
the active ingredient for each drug or
biological product not subject to an
approved application or license, the
national drug code (NDC) number, and
any drug imprinting information.
In addition to the product listing
information required, FDA may also
require, under § 207.31, a copy of all
advertisements and a quantitative listing
of all ingredients for each listed drug or
biological product not subject to an
approved application or license; the
basis for a determination, by the
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establishment, that a listed drug or
biological product is not subject to
marketing or licensing approval
requirements; and a list of certain drugs
or biological products containing a
particular ingredient. FDA may also
request, but not require, the submission
of a qualitative listing of the inactive
ingredients for all listed drugs or
biological products, and a quantitative
listing of the active ingredients for all
listed drugs or biological products
subject to an approved application or
license.
Under § 207.30, establishments must
update their product listing information
every June and December or, at the
discretion of the establishment, when
any change occurs. These updates must
include the following information: (1) A
listing of all drug or biological products
introduced for commercial distribution
that have not been included in any
previously submitted list; (2) all drug or
biological products formerly listed for
which commercial distribution has been
discontinued; (3) all drug or biological
products for which a notice of
discontinuance was submitted and for
which commercial distribution has been
resumed; and (4) any material change in
any information previously submitted.
No update is required if no changes
have occurred since the previously
submitted list.
Historically, drug establishment
registration and drug listing information
have been submitted in paper form
using Form FDA 2656 (Registration of
Drug Establishment/Labeler Code
Assignment), Form FDA 2657 (Drug
Product Listing), and Form FDA 2658
(Registered Establishments’ Report of
Private Label Distributors) (collectively
referred to as FDA Forms). Changes in
the FD&C Act resulting from enactment
of the Food and Drug Administration
Amendments Act of 2007 (Pub. L. 110–
85) (FDAAA) require that drug
establishment registration and drug
listing information be submitted
electronically unless a waiver is
granted. Before the enactment of
FDAAA, section 510(p) of the FD&C Act
expressly provided for electronic
submission of drug establishment
registration information upon a finding
that electronic receipt was feasible, and
section 510(j) of the FD&C Act provided
that drug listing information be
submitted in the form and manner
prescribed by FDA. Section 224 of
FDAAA, which amends section 510(p)
of the FD&C Act, now expressly,
requires electronic drug listing in
addition to drug establishment
registration. In certain cases, if it is
unreasonable to expect a person to
submit registration and listing
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37623
information electronically, FDA may
grant a waiver from the electronic
format requirement.
In the Federal Register of June 1, 2009
(74 FR 26248), FDA announced the
availability of a guidance for industry
entitled ‘‘Providing Regulatory
Submissions in Electronic Format—
Drug Establishment Registration and
Drug Listing’’ (the 2009 guidance). The
document provides guidance to industry
on the statutory requirement to submit
electronically drug establishment
registration and drug listing
information. The guidance describes the
types of information to include for
purposes of drug establishment
registration and drug listing and how to
prepare and submit the information in
an electronic format (Structured Product
Labeling (SPL) files) that FDA can
process, review, and archive. In
addition to the information that
previously was collected on the FDA
Forms, the guidance addresses
electronic submission of other required
information as follows:
• For registered foreign drug
establishments, the name, address, and
telephone number of its U.S. agent
(§ 207.40(c));
• the name of each importer that is
known to the establishment (the U.S.
company or individual in the United
States that is an owner, consignee, or
recipient of the foreign establishment’s
drug that is imported into the United
States. An importer does not include the
consumer or patient who ultimately
purchases, receives, or is administered
the drug, unless the foreign
establishment ships the drug directly to
the consumer or the patient) (section
510(i)(1)(A) of the FD&C Act); and
• the name of each person who
imports or offers for import (the name
of each agent, broker, or other entity,
other than a carrier, that the foreign
drug establishment uses to facilitate the
import of their drug into the United
States) (section 510(i)(1)(A) of the FD&C
Act).
FDA also recommends the voluntary
submission of the following additional
information, when applicable:
• To facilitate correspondence
between foreign establishments and
FDA, the email address for the U.S.
agent, and the telephone number(s) and
email address for the importer and
person who imports or offers for import
their drug;
• a site-specific Data Universal
Numbering System number for each
entity (e.g., the registrant,
establishments, U.S. agent, importer);
• the NDC product code for the
source drug that is repacked or
relabeled;
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Federal Register / Vol. 80, No. 126 / Wednesday, July 1, 2015 / Notices
• distinctive characteristics of certain
listed drugs, i.e., the flavor, the color,
and image of the actual solid dosage
form; and
• registrants may indicate that they
view as confidential the registrant’s
business relationship with an
establishment, or an inactive ingredient.
In addition to this collection of
information, there is an additional
burden for the following activities:
• preparing a standard operating
procedure (SOP) for the electronic
submission of drug establishment
registration and drug listing
information;
• creating the SPL file, including
accessing and reviewing the technical
specifications and instructional
documents provided by FDA (accessible
at https://www.fda.gov/oc/datacouncil/
spl.html);
• reviewing and selecting appropriate
terms and codes used to create the SPL
file (accessible at https://www.fda.gov/
oc/datacouncil/spl.html);
• obtaining the digital certificate used
with FDA’s electronic submission
gateway and uploading the SPL file for
submission (accessible at https://
www.fda.gov/esg/default.htm); and
• requests for waivers from the
electronic submission process as
described in the draft guidance.
When FDA published the 2009
guidance on submitting establishment
registration and drug listing information
in electronic format, the Agency also
amended its burden estimates for OMB
control number 0910–0045 to include
the additional burden for the collection
of information that had not been
submitted using the FDA forms, and to
create and upload the SPL file. The
amended burden estimates included the
one-time preparation of an SOP for
creating and uploading the SPL file.
Although most firms will already have
prepared an SOP for the electronic
submission of drug establishment
registration and drug listing
information, each year additional firms
will need to create an SOP. As provided
in Table 2, FDA estimates that
approximately 1,000 firms will have to
expend a one-time burden to prepare,
review, and approve an SOP, and the
Agency estimates that it will take 40
hours per recordkeeper to create 1,000
new SOPs for a total of 40,000 hours.
In the Federal Register of March 23,
2015 (80 FR 15214), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. FDA received one
comment.
The comment noted that under
§ 207.20(a), manufacturers, repackers,
and relabelers are required to register
their establishment and submit a listing
of every drug or biological product in
commercial distribution. Under
§ 207.20(b), owners or operators of
establishments that distribute under
their own label or trade name a drug
product manufactured by a registered
establishment are not required either to
register or list but may elect to submit
drug listing information in lieu of the
registered establishment that
manufactures the drug product. The
comment said that although the burden
of listing private label drugs rests on the
manufacturer, the standard industry
practice has been to submit two separate
listings under different marketing
categories. The comment said that these
listings are submitted either by the
private label distributor or by the
manufacturer and ‘‘in order for the
necessary information to be provided to
FDA (all Offices and Centers) both
listings are necessary.’’ The comment
also recommended that all drug listings
should include the marketing category
of the drug.
FDA Response: Under section 510 of
the FD&C Act and part 207, contract
manufacturers (registered
establishments) are required to list their
products with FDA under their own
labeler code. To properly identify such
a listing, contract manufacturers should
list products manufactured for a private
label distributor by using one of
following marketing categories: (1)
Approved Drug Product Manufactured
Exclusively For Private Label
Distributor; (2) OTC Monograph Drug
Product Manufactured Exclusively For
Private Label Distributor; (3)
Unapproved Drug Product
Manufactured Exclusively For Private
Label Distributor. Contract
manufacturers may also include the
private label distributor’s labeling with
the listing submission.
Additionally, § 207.20(b) requires that
the private label distributor have its
product listed under its own labeler
code (using whatever marketing
category is appropriate to the finished
product (e.g., NDA, OTC Monograph,
Unapproved Drug)). The private label
distributor may elect to do this on its
own. If the private label distributor
elects not to do this, then the
responsibility for submitting the
additional listing falls on the registered
establishment (the contract
manufacturer).
In Tables 1 and 2, the information
collection requirements of the drug
establishment registration and drug
listing requirements have been grouped
according to the information collection
areas of the requirements.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
tkelley on DSK3SPTVN1PROD with NOTICES
Activity
New registrations, including new labeler codes requests ......................
Annual updates of registration information .............................................
New drug listings ...............................
New listings for private label distributor ............................................
June and December updates of all
drug listing information ...................
Waiver requests .................................
Total ............................................
1 There
Number of
responses per respondent
Total annual
responses
Average burden per
response
1,400
2
2,800
4.5
12,600
10,000
1,567
1
7
10,000
11,000
4.5
4.5
45,000
49,500
1,469
4.5
6,611
106,000
1
4.5
1
477,000
1
146
10.06
5,300
1
..............................
20
1
................................
..............................
................................
are no capital costs or operating and maintenance costs associated with this collection of information.
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Total hours
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Federal Register / Vol. 80, No. 126 / Wednesday, July 1, 2015 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Activity resulting from Section 510(p) of
the FD&C Act as amended by FDAAA
Number of recordkeepers
Number of records
per recordkeeper
One-time preparation of SOP ................
SOP maintenance ..................................
Total ................................................
1,000
3,295
43,295
1
1
1 There
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–2044]
Authorization of Emergency Use of an
In Vitro Diagnostic Device for
Detection of Enterovirus D68;
Availability
Food and Drug Administration,
HHS.
Notice.
The Food and Drug
Administration (FDA) is announcing the
issuance of an Emergency Use
Authorization (EUA) (the Authorization)
for in an vitro diagnostic device for
detection of Enterovirus D68 (EV–D68)
strains detected in North America in
2014. FDA issued this Authorization
under the Federal Food, Drug, and
Cosmetic Act (the FD&C Act), as
requested by the Centers for Disease
Control and Prevention (CDC). The
Authorization contains, among other
things, conditions on the emergency use
of the authorized in vitro diagnostic
device. The Authorization follows the
February 6, 2015, determination by the
Department of Health and Human
Services (HHS) Secretary that there is a
significant potential for a public health
emergency that has a significant
potential to affect national security or
the health and security of U.S. citizens
living abroad and that involves EV–D68.
On the basis of such determination, the
Secretary of HHS also declared on
February 6, 2015, that circumstances
exist justifying the authorization of
emergency use of in vitro diagnostic
devices for detection of EV–D68 subject
to the terms of any authorization issued
under the FD&C Act. The Authorization,
which includes an explanation of the
reasons for issuance, is reprinted in this
document.
SUMMARY:
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1,000
3,295
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18:30 Jun 30, 2015
Jkt 235001
The Authorization is effective as
of May 12, 2015.
ADDRESSES: Submit written requests for
single copies of the EUA to the Office
of Counterterrorism and Emerging
Threats, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 1,
Rm. 4338, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your request or include a fax number to
which the Authorization may be sent.
See the SUPPLEMENTARY INFORMATION
section for electronic access to the
Authorization.
DATES:
[FR Doc. 2015–16129 Filed 6–30–15; 8:45 am]
ACTION:
Average burden
per recordkeeping
40
1
Total hours
40,000
3,295
are no capital costs or operating and maintenance costs associated with the collection of information.
Dated: June 25, 2015.
Leslie Kux,
Associate Commissioner for Policy.
AGENCY:
Total annual
records
FOR FURTHER INFORMATION CONTACT:
Carmen Maher, Acting Assistant
Commissioner for Counterterrorism
Policy and Acting Director, Office of
Counterterrorism and Emerging Threats,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 1, Rm.
4347, Silver Spring, MD 20993–0002,
301–796–8510.
SUPPLEMENTARY INFORMATION:
I. Background
Section 564 of the FD&C Act (21
U.S.C. 360bbb–3) as amended by the
Project BioShield Act of 2004 (Pub. L.
108–276) and the Pandemic and AllHazards Preparedness Reauthorization
Act of 2013 (Pub. L. 113–5) allows FDA
to strengthen the public health
protections against biological, chemical,
nuclear, and radiological agents. Among
other things, section 564 of the FD&C
Act allows FDA to authorize the use of
an unapproved medical product or an
unapproved use of an approved medical
product in certain situations. With this
EUA authority, FDA can help assure
that medical countermeasures may be
used in emergencies to diagnose, treat,
or prevent serious or life-threatening
diseases or conditions caused by
biological, chemical, nuclear, or
radiological agents when there are no
adequate, approved, and available
alternatives.
Section 564(b)(1) of the FD&C Act
provides that, before an EUA may be
issued, the Secretary of HHS must
declare that circumstances exist
justifying the authorization based on
one of the following grounds: (1) A
determination by the Secretary of
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Homeland Security that there is a
domestic emergency, or a significant
potential for a domestic emergency,
involving a heightened risk of attack
with a biological, chemical, radiological,
or nuclear agent or agents; (2) a
determination by the Secretary of
Defense that there is a military
emergency, or a significant potential for
a military emergency, involving a
heightened risk to U.S. military forces of
attack with a biological, chemical,
radiological, or nuclear agent or agents;
(3) a determination by the Secretary of
HHS that there is a public health
emergency, or a significant potential for
a public health emergency, that affects,
or has a significant potential to affect,
national security or the health and
security of U.S. citizens living abroad,
and that involves a biological, chemical,
radiological, or nuclear agent or agents,
or a disease or condition that may be
attributable to such agent or agents; or
(4) the identification of a material threat
by the Secretary of Homeland Security
under section 319F–2 of the Public
Health Service (PHS) Act (42 U.S.C.
247d–6b) sufficient to affect national
security or the health and security of
U.S. citizens living abroad.
Once the Secretary of HHS has
declared that circumstances exist
justifying an authorization under
section 564 of the FD&C Act, FDA may
authorize the emergency use of a drug,
device, or biological product if the
Agency concludes that the statutory
criteria are satisfied. Under section
564(h)(1) of the FD&C Act, FDA is
required to publish in the Federal
Register a notice of each authorization,
and each termination or revocation of an
authorization, and an explanation of the
reasons for the action. Section 564 of the
FD&C Act permits FDA to authorize the
introduction into interstate commerce of
a drug, device, or biological product
intended for use when the Secretary of
HHS has declared that circumstances
exist justifying the authorization of
emergency use. Products appropriate for
emergency use may include products
and uses that are not approved, cleared,
or licensed under sections 505, 510(k),
or 515 of the FD&C Act (21 U.S.C. 355,
360(k), and 360e) or section 351 of the
PHS Act (42 U.S.C. 262).
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]]>Agencies
[Federal Register Volume 80, Number 126 (Wednesday, July 1, 2015)]
[Notices]
[Pages 37622-37625]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-16129]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0742]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Registration of
Producers of Drugs and Listing of Drugs in Commercial Distribution
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by July
31, 2015.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0045.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Registration of Producers of Drugs and Listing of Drugs in Commercial
Distribution--21 CFR Part 207
OMB Control Number 0910-0045--Extension
Requirements for drug establishment registration and drug listing
are set forth in section 510 of the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C. 360), section 351 of the Public Health
Service Act (42 U.S.C. 262), and part 207 (21 CFR part 207).
Fundamental to FDA's mission to protect the public health is the
collection of this information, which is used for important activities
such as postmarket surveillance for serious adverse drug reactions,
inspection of drug manufacturing and processing facilities, and
monitoring of drug products imported into the United States.
Comprehensive, accurate, and up to date information is critical to
conducting these activities with efficiency and effectiveness.
Under section 510 of the FD&C Act, FDA is authorized to establish a
system for registration of producers of drugs and for listing of drugs
in commercial distribution. To implement section 510 of the FD&C Act,
FDA issued part 207. Under current Sec. 207.20, manufacturers,
repackers, and relabelers that engage in the manufacture, preparation,
propagation, compounding, or processing of human or veterinary drugs
and biological products, including bulk drug substances and bulk drug
substances for prescription compounding, and drug premixes as well as
finished dosage forms, whether prescription or over-the-counter, are
required to register their establishment. In addition, manufacturers,
repackers, and relabelers are required to submit a listing of every
drug or biological product in commercial distribution. Owners or
operators of establishments that distribute under their own label or
trade name a drug product manufactured by a registered establishment
are not required either to register or list. However, distributors may
elect to submit drug listing information in lieu of the registered
[[Page 37623]]
establishment that manufactures the drug product. Foreign drug
establishments must also comply with the establishment registration and
product listing requirements if they import or offer for import their
products into the United States.
Under current Sec. 207.21, establishments, both domestic and
foreign, must register with FDA within 5 days after beginning the
manufacture of drugs or biologicals, or within 5 days after the
submission of a drug application or biological license application. In
addition, establishments must register annually. Changes in individual
ownership, corporate or partnership structure, location, or drug
handling activity must be submitted as amendments to registration under
current Sec. 207.26 within 5 days of such changes. Under Sec.
207.20(b), private label distributors may request their own labeler
code and elect to submit drug listing information to FDA. In such
instances, at the time of submitting or updating drug listing
information, private label distributors must certify to the registered
establishment that manufactured, prepared, propagated, compounded, or
processed (which includes, among other things, repackaging and
relabeling) the listed drug that the drug listing submission was made.
Establishments must, within 5 days of beginning the manufacture of
drugs or biologicals, submit to FDA a listing for every drug or
biological product in commercial distribution at that time. Private
label distributors may elect to submit to FDA a listing of every drug
product they place in commercial distribution. Registered
establishments must submit to FDA drug product listing for those
private label distributors who do not elect to submit listing
information.
Under Sec. 207.25, product listing information submitted to FDA by
domestic and foreign manufacturers must, depending on the type of
product being listed, include any new drug application number or
biological establishment license number, copies of current labeling and
a sampling of advertisements, a quantitative listing of the active
ingredient for each drug or biological product not subject to an
approved application or license, the national drug code (NDC) number,
and any drug imprinting information.
In addition to the product listing information required, FDA may
also require, under Sec. 207.31, a copy of all advertisements and a
quantitative listing of all ingredients for each listed drug or
biological product not subject to an approved application or license;
the basis for a determination, by the establishment, that a listed drug
or biological product is not subject to marketing or licensing approval
requirements; and a list of certain drugs or biological products
containing a particular ingredient. FDA may also request, but not
require, the submission of a qualitative listing of the inactive
ingredients for all listed drugs or biological products, and a
quantitative listing of the active ingredients for all listed drugs or
biological products subject to an approved application or license.
Under Sec. 207.30, establishments must update their product
listing information every June and December or, at the discretion of
the establishment, when any change occurs. These updates must include
the following information: (1) A listing of all drug or biological
products introduced for commercial distribution that have not been
included in any previously submitted list; (2) all drug or biological
products formerly listed for which commercial distribution has been
discontinued; (3) all drug or biological products for which a notice of
discontinuance was submitted and for which commercial distribution has
been resumed; and (4) any material change in any information previously
submitted. No update is required if no changes have occurred since the
previously submitted list.
Historically, drug establishment registration and drug listing
information have been submitted in paper form using Form FDA 2656
(Registration of Drug Establishment/Labeler Code Assignment), Form FDA
2657 (Drug Product Listing), and Form FDA 2658 (Registered
Establishments' Report of Private Label Distributors) (collectively
referred to as FDA Forms). Changes in the FD&C Act resulting from
enactment of the Food and Drug Administration Amendments Act of 2007
(Pub. L. 110-85) (FDAAA) require that drug establishment registration
and drug listing information be submitted electronically unless a
waiver is granted. Before the enactment of FDAAA, section 510(p) of the
FD&C Act expressly provided for electronic submission of drug
establishment registration information upon a finding that electronic
receipt was feasible, and section 510(j) of the FD&C Act provided that
drug listing information be submitted in the form and manner prescribed
by FDA. Section 224 of FDAAA, which amends section 510(p) of the FD&C
Act, now expressly, requires electronic drug listing in addition to
drug establishment registration. In certain cases, if it is
unreasonable to expect a person to submit registration and listing
information electronically, FDA may grant a waiver from the electronic
format requirement.
In the Federal Register of June 1, 2009 (74 FR 26248), FDA
announced the availability of a guidance for industry entitled
``Providing Regulatory Submissions in Electronic Format--Drug
Establishment Registration and Drug Listing'' (the 2009 guidance). The
document provides guidance to industry on the statutory requirement to
submit electronically drug establishment registration and drug listing
information. The guidance describes the types of information to include
for purposes of drug establishment registration and drug listing and
how to prepare and submit the information in an electronic format
(Structured Product Labeling (SPL) files) that FDA can process, review,
and archive. In addition to the information that previously was
collected on the FDA Forms, the guidance addresses electronic
submission of other required information as follows:
For registered foreign drug establishments, the name,
address, and telephone number of its U.S. agent (Sec. 207.40(c));
the name of each importer that is known to the
establishment (the U.S. company or individual in the United States that
is an owner, consignee, or recipient of the foreign establishment's
drug that is imported into the United States. An importer does not
include the consumer or patient who ultimately purchases, receives, or
is administered the drug, unless the foreign establishment ships the
drug directly to the consumer or the patient) (section 510(i)(1)(A) of
the FD&C Act); and
the name of each person who imports or offers for import
(the name of each agent, broker, or other entity, other than a carrier,
that the foreign drug establishment uses to facilitate the import of
their drug into the United States) (section 510(i)(1)(A) of the FD&C
Act).
FDA also recommends the voluntary submission of the following
additional information, when applicable:
To facilitate correspondence between foreign
establishments and FDA, the email address for the U.S. agent, and the
telephone number(s) and email address for the importer and person who
imports or offers for import their drug;
a site-specific Data Universal Numbering System number for
each entity (e.g., the registrant, establishments, U.S. agent,
importer);
the NDC product code for the source drug that is repacked
or relabeled;
[[Page 37624]]
distinctive characteristics of certain listed drugs, i.e.,
the flavor, the color, and image of the actual solid dosage form; and
registrants may indicate that they view as confidential
the registrant's business relationship with an establishment, or an
inactive ingredient.
In addition to this collection of information, there is an
additional burden for the following activities:
preparing a standard operating procedure (SOP) for the
electronic submission of drug establishment registration and drug
listing information;
creating the SPL file, including accessing and reviewing
the technical specifications and instructional documents provided by
FDA (accessible at https://www.fda.gov/oc/datacouncil/spl.html);
reviewing and selecting appropriate terms and codes used
to create the SPL file (accessible at https://www.fda.gov/oc/datacouncil/spl.html);
obtaining the digital certificate used with FDA's
electronic submission gateway and uploading the SPL file for submission
(accessible at https://www.fda.gov/esg/default.htm); and
requests for waivers from the electronic submission
process as described in the draft guidance.
When FDA published the 2009 guidance on submitting establishment
registration and drug listing information in electronic format, the
Agency also amended its burden estimates for OMB control number 0910-
0045 to include the additional burden for the collection of information
that had not been submitted using the FDA forms, and to create and
upload the SPL file. The amended burden estimates included the one-time
preparation of an SOP for creating and uploading the SPL file. Although
most firms will already have prepared an SOP for the electronic
submission of drug establishment registration and drug listing
information, each year additional firms will need to create an SOP. As
provided in Table 2, FDA estimates that approximately 1,000 firms will
have to expend a one-time burden to prepare, review, and approve an
SOP, and the Agency estimates that it will take 40 hours per
recordkeeper to create 1,000 new SOPs for a total of 40,000 hours.
In the Federal Register of March 23, 2015 (80 FR 15214), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received one comment.
The comment noted that under Sec. 207.20(a), manufacturers,
repackers, and relabelers are required to register their establishment
and submit a listing of every drug or biological product in commercial
distribution. Under Sec. 207.20(b), owners or operators of
establishments that distribute under their own label or trade name a
drug product manufactured by a registered establishment are not
required either to register or list but may elect to submit drug
listing information in lieu of the registered establishment that
manufactures the drug product. The comment said that although the
burden of listing private label drugs rests on the manufacturer, the
standard industry practice has been to submit two separate listings
under different marketing categories. The comment said that these
listings are submitted either by the private label distributor or by
the manufacturer and ``in order for the necessary information to be
provided to FDA (all Offices and Centers) both listings are
necessary.'' The comment also recommended that all drug listings should
include the marketing category of the drug.
FDA Response: Under section 510 of the FD&C Act and part 207,
contract manufacturers (registered establishments) are required to list
their products with FDA under their own labeler code. To properly
identify such a listing, contract manufacturers should list products
manufactured for a private label distributor by using one of following
marketing categories: (1) Approved Drug Product Manufactured
Exclusively For Private Label Distributor; (2) OTC Monograph Drug
Product Manufactured Exclusively For Private Label Distributor; (3)
Unapproved Drug Product Manufactured Exclusively For Private Label
Distributor. Contract manufacturers may also include the private label
distributor's labeling with the listing submission.
Additionally, Sec. 207.20(b) requires that the private label
distributor have its product listed under its own labeler code (using
whatever marketing category is appropriate to the finished product
(e.g., NDA, OTC Monograph, Unapproved Drug)). The private label
distributor may elect to do this on its own. If the private label
distributor elects not to do this, then the responsibility for
submitting the additional listing falls on the registered establishment
(the contract manufacturer).
In Tables 1 and 2, the information collection requirements of the
drug establishment registration and drug listing requirements have been
grouped according to the information collection areas of the
requirements.
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden per Total hours
respondents respondent responses response
--------------------------------------------------------------------------------------------------------------------------------------------------------
New registrations, including new labeler codes requests 1,400 2 2,800 4.5 12,600
Annual updates of registration information............. 10,000 1 10,000 4.5 45,000
New drug listings...................................... 1,567 7 11,000 4.5 49,500
New listings for private label distributor............. 146 10.06 1,469 4.5 6,611
June and December updates of all drug listing 5,300 20 106,000 4.5 477,000
information...........................................
Waiver requests........................................ 1 1 1 1 1
------------------------------------------------------------------------------------------------
Total.............................................. ................. .................. ................. .................. 590,712
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 37625]]
Table 2--Estimated Annual Recordkeeping Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
Activity resulting from Section 510(p) of the FD&C Act as Number of Number of records Total annual Average burden
amended by FDAAA recordkeepers per recordkeeper records per recordkeeping Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
One-time preparation of SOP.............................. 1,000 1 1,000 40 40,000
SOP maintenance.......................................... 3,295 1 3,295 1 3,295
Total................................................ 43,295
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with the collection of information.
Dated: June 25, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-16129 Filed 6-30-15; 8:45 am]
BILLING CODE 4164-01-P
