83 FR 55898 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 217 (November 8, 2018)

Page Range		55898-55900
FR Document		2018-24440

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.

Federal Register, Volume 83 Issue 217 (Thursday, November 8, 2018)

[Federal Register Volume 83, Number 217 (Thursday, November 8, 2018)]
[Notices]
[Pages 55898-55900]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-24440]

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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
December 10, 2018.

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: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794,
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

This information collection supports FDA's drug establishment
registration and listing regulations and associated guidance intended
to assist respondents in this regard. Requirements for drug
establishment registration and drug listing are set forth in section
510 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C.
360), and section 351 of the Public Health Service Act (42 U.S.C. 262).
Section 224 of the Food and Drug Administration Amendments Act of 2007
(Pub. L. 110-85) amended section 510(p) of the FD&C Act to require
electronic drug establishment registration and drug listing.
Regulations implementing these provisions are established under part
207 (21 CFR part 207). Except as provided in Sec. 207.65, all
information submitted must be transmitted to FDA in electronic format
by using our electronic drug registration and listing system, in a form
that we can process, review, and archive. Establishment registration
information helps FDA identify who is manufacturing, repacking,
relabeling, and salvaging drugs and where those operations are
performed. Drug listing information gives FDA a current inventory of
drugs manufactured, repacked, relabeled, or salvaged for commercial
distribution. Both types of information facilitate implementation and
enforcement of the FD&C Act and are used for many important public
health purposes.

I. Registration Under Part 207

Unless otherwise exempt under section 510(g) of the FD&C Act or
Sec. 207.13, all manufacturers, repackers, relabelers, and salvagers
must register each domestic establishment that manufactures, repacks,
relabels, or salvages a drug, or an animal feed bearing or containing a
new animal drug, and each foreign establishment that manufactures,
repacks, relabels, or salvages a drug, or an animal feed bearing or
containing a new animal drug, that is imported or offered for import
into the United States. When operations are conducted at more than one
establishment and common ownership and control among all the
establishments exists, the parent, subsidiary, or affiliate company may
submit registration information for all establishments.
Private label distributors who do not also manufacture, repack,
relabel, or salvage drugs are not required to register under part 207.
FDA will accept registration or listing information submitted by a
private label distributor only if it is acting as an authorized agent
for and submitting information that pertains to an establishment that
manufactures, repacks, relabels, or salvages drugs.
Under Sec. 207.21, domestic manufacturers, domestic repackers,
domestic relabelers, and domestic drug product salvagers must complete
initial registration of each establishment no later than 5 calendar
days after beginning to manufacture, repack, relabel, or salvage a
drug. In addition, foreign manufacturers, foreign repackers, foreign
relabelers, and foreign drug product salvagers must register each
establishment before the drug is imported or offered for import into
the United States.
The information that must be provided to FDA for registration is
described in Sec. 207.25 and includes the following: (1) Name of the
owner or operator of each establishment; if a partnership, the name of
each partner; if a corporation, the name of each corporate officer and
director, and the place of incorporation; (2) each establishment's
name, physical address, and telephone number(s); (3) all name(s) of the
establishment, including names under which the establishment conducts
business or names by which the establishment is known; (4) registration
number of each establishment, if previously assigned by FDA; (5) a
Unique Facility Identifier in accordance with the system specified
under section 510 of the FD&C Act; (6) all types of operations
performed at each establishment; (7) name, mailing address, telephone
number, and email address of the official contact for the
establishment, as provided in Sec. 207.69(a); and (8) additionally,
with respect to foreign establishments subject to registration, the
name, mailing address, telephone number, and email address must be
provided for: (a) The U.S. agent, as provided in Sec. 207.69(b); (b)
each importer in the United States of drugs manufactured, repacked,

[[Page 55899]]

relabeled, or salvaged at the establishment that is known to the
establishment; and (c) each person who imports or offers for import
such drug to the United States.
Registrants must update their registration information as
prescribed under Sec. 207.29.

II. National Drug Code (NDC)

The NDC for a drug is a numeric code. Each finished drug product or
unfinished drug subject to the listing requirements of part 207 must
have a unique NDC to identify its labeler, product, and package size
and type. The format of an NDC is described under Sec. 207.33.
Under Sec. 207.35, registrants must notify us of a change in any
of the drug characteristics (except certain identifying information)
for an NDC in Sec. 207.33, and assign a new product code and package
code for that drug.

III. Listing Under Part 207

Under Sec. 207.41, registrants must list each drug that it
manufactures, repacks, relabels, or salvages for commercial
distribution. Each domestic registrant must list each such drug
regardless of whether the drug enters interstate commerce. When
operations are conducted at more than one establishment, and common
ownership and control exists among all the establishments, the parent,
subsidiary, or affiliate company may submit listing information for any
drug manufactured, repacked, relabeled, or salvaged at any such
establishment. A drug manufactured, repacked, or relabeled for private
label distribution must be listed in accordance with the requirements.
Registrants must provide listing information for each drug in
accordance with the listing requirements described in Sec. Sec.
207.49, 207.53, and 207.54 that correspond to the activity or
activities they engage in for that drug. For both animal and human
drugs, each registrant must list each drug it manufactures, repacks, or
relabels for commercial distribution under the trade name or label of a
private label distributor using an NDC that includes such private label
distributor's labeler code.
Additionally, in the case of human drugs, each registrant must list
each human drug it manufactures, repacks, or relabels using an NDC that
includes the registrant's own labeler code, regardless of whether the
drug is commercially distributed under the registrant's own label or
trade name or under the label or trade name of a private label
distributor.
Under Sec. 207.45, for each drug being manufactured, repacked,
relabeled, or salvaged for commercial distribution at an establishment
at the time of initial registration, drug listing information must be
submitted no later than 3 calendar days after the initial registration
of the establishment.
Each registrant must provide the listing information described
under Sec. 207.49 for each drug it manufactures for commercial
distribution. Each registrant must also provide the listing information
for each drug it repacks or relabels under Sec. 207.53. A registrant
who also relabels or repacks a drug that it salvages must list the drug
it relabels or repacks in accordance with Sec. 207.53. Registrants who
perform only salvaging with respect to a drug must provide the listing
information for that drug as required under Sec. 207.54. Additional
information may be requested for a listed drug as described in Sec.
207.55.
Under Sec. 207.57, registrants must update drug listing
information submitted previously (either when the change is made or, at
a minimum, each June and December). Registrants must also notify FDA if
any listed drug has been discontinued from marketing or if any
discontinued drug has been reintroduced and provide listing information
for any drug not yet listed (at the time of annual establishment
registration if not sooner).
In the Federal Register of July 18, 2018 (83 FR 33934), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this information collection as follows:

Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity; 21 CFR section(s) Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Initial establishment registration; Sec. 1,480 2 2,960 1 2,960
Sec. 207.17, 207.21, 207.25.
Annual review and update of registration 10,000 1 10,000 0.5 (30 minutes) 5,000
information (including expedited updates);
Sec. 207.29.
Initial listing (including NDC); Sec. Sec. 1,713 7.28 12,470 1.5 18,705
207.33, 207.41, 207.45, 207.49, 207.53,
207.54, 207.55.
June and December review and update (or 5,300 20 106,000 0.75 (45 minutes) 79,500
certification) of listing; Sec. Sec.
207.35, 207.57.
Waiver requests; Sec. 207.65............... 1 1 1 0.5 (30 minutes) 1
Public disclosure exemption requests; Sec. 100 1 100 1 100
207.81(c).
------------------------------------------------ ---------------
Total.................................... .............. .............. .............. ......................................... 106,266
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital or operating and maintenance costs associated with the information collection.

Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
Standard Operating Procedure (SOP) for creating and uploading the Number of records per Total annual per Total hours
Structured Product Labeling file recordkeepers recordkeeper records recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
Preparation of SOP................................................. 1,000 1 1,000 40 40,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital or operating and maintenance costs associated with the information collection.

[[Page 55900]]

Based on FDA data, we estimate that 1,480 respondents will submit
2,960 new establishment registrations annually. Based on the number of
registered establishments in our database, we estimate 10,000
registrants will provide 10,000 annual reviews and updates of
registration information (including expedited updates) or reviews and
certifications that no changes have occurred. The estimates include the
registration of establishments for both domestic and foreign
manufacturers, repackers, relabelers, and drug product salvagers, and
registration information submitted by anyone acting as an authorized
agent for an establishment that manufactures, repacks, relabels, or
salvages drugs. The estimates include an additional 80 positron
emission tomography (PET) drug producers who are not exempt from
registration and approximately 30 manufacturers of plasma derivatives.
We estimate that it will take 1 hour for registrants to submit
initial registration information electronically for each new
establishment. We also estimate that it will take approximately 30
minutes for each annual review and update of registration information
(including any expedited updates) or each review and certification that
no changes have occurred. The burden hour estimates above are based on
our familiarity with the amount of time it takes registrants to input
registration information electronically since June 2009. The estimates
are an average of the time it would take to register a domestic or
foreign establishment and an average of the time it would take to
review registration information and update several registration items
in the database or review registration information and only certify
that no changes have occurred.
Based on the number of drugs listed annually since June 2009, we
estimate that approximately 1,713 registrants will report 12,469 new
listings annually (including the information submitted to obtain a
labeler code and to reserve an NDC for future use).
Based on the number of drugs in our listing database and the
current number of changes to listing information submitted, we estimate
5,300 registrants will each report 20 reviews and updates (including
the information submitted to revise an NDC) for a total of 106,000
annually.
The estimates for the number of drug listings include both domestic
and foreign listings, listings submitted by registrants for products
sold under their own names as well as products intended for private
label distribution, and information submitted related to an NDC and to
obtain a labeler code. The estimate for the number of drugs subject to
the listing requirements includes PET drugs and approximately 30 plasma
derivatives. The estimates for the number of June and December reviews
and updates of listing information include the number of changes to
drug characteristics pertaining to the drug product code to obtain a
new NDC and the reports of the withdrawal of an approved drug from sale
under Sec. 314.81(b)(3)(iii) (21 CFR 314.81(b)(3)(iii)).
Based on our familiarity with the time required to input listing
information electronically since June 2009, we estimate that it will
take registrants 1 hour and 30 minutes to submit information
electronically for each drug they list for the first time (for both
foreign and domestic registrant listings). These estimates are an
average of the time it will take manufacturers, repackers, relabelers,
and drug product salvagers, with drug product salvagers taking
considerably less time than manufacturers. The estimates include the
time for submitting the content of labeling and other labeling in
electronic format. (For drugs subject to an approved marketing
application, the electronic submission of the content of labeling under
Sec. 314.50(l)(1)(i) is approved under OMB control number 0910-0001.)
We also estimate that it will take 45 minutes for each June and
December review and update. These estimates represent the average
amount of time to review and update listing information or to review
and certify that no changes have occurred. The estimates include the
time for submitting any labeling for each drug, changes to the drug's
characteristics submitted for a new NDC, and reports of the withdrawal
of an approved drug from sale under Sec. 314.81(b)(3)(iii).
In 2009, to help respondents transition to the current electronic
reporting requirements, FDA issued the guidance for industry entitled
``Providing Regulatory Submissions in Electronic Format--Drug
Establishment Registration and Drug Listing.'' 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. The burden attributed to the guidance includes the
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
reflected in table 2, FDA estimates that approximately 1,000 firms will
expend 40 hours to prepare, review, and approve an SOP, for a total of
40,000 hours annually.
Cumulatively, the information collection reflects a decrease of
3,295 in both annual responses and burden hours. This adjustment
results from eliminating burden previously attributable to guidance
recommendations for creating drug establishment registration and drug
listing files for electronic submission. Because electronic
registration and listing is now mandatory, we believe respondents have
since developed and implemented SOPs consistent with meeting the
technical format specifications set forth in the regulations and we no
longer attribute burden to this activity.

Dated: November 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-24440 Filed 11-7-18; 8:45 am]
BILLING CODE 4164-01-P

55900 Federal Register / Vol. 83, No. 217 / Thursday, November 8, 2018 / Notices

Based on FDA data, we estimate that NDC and to obtain a labeler code. The creating and uploading the SPL file.
1,480 respondents will submit 2,960 estimate for the number of drugs subject Although most firms will already have
new establishment registrations to the listing requirements includes PET prepared an SOP for the electronic
annually. Based on the number of drugs and approximately 30 plasma submission of drug establishment
registered establishments in our derivatives. The estimates for the registration and drug listing
database, we estimate 10,000 registrants number of June and December reviews information, each year additional firms
will provide 10,000 annual reviews and and updates of listing information will need to create an SOP. As reflected
updates of registration information include the number of changes to drug in table 2, FDA estimates that
(including expedited updates) or characteristics pertaining to the drug approximately 1,000 firms will expend
reviews and certifications that no product code to obtain a new NDC and 40 hours to prepare, review, and
changes have occurred. The estimates the reports of the withdrawal of an approve an SOP, for a total of 40,000
include the registration of approved drug from sale under hours annually.
establishments for both domestic and § 314.81(b)(3)(iii) (21 CFR Cumulatively, the information
foreign manufacturers, repackers, 314.81(b)(3)(iii)). collection reflects a decrease of 3,295 in
relabelers, and drug product salvagers, Based on our familiarity with the time both annual responses and burden
and registration information submitted required to input listing information hours. This adjustment results from
by anyone acting as an authorized agent electronically since June 2009, we eliminating burden previously
for an establishment that manufactures, estimate that it will take registrants 1 attributable to guidance
repacks, relabels, or salvages drugs. The hour and 30 minutes to submit recommendations for creating drug
estimates include an additional 80 information electronically for each drug establishment registration and drug
positron emission tomography (PET) they list for the first time (for both listing files for electronic submission.
drug producers who are not exempt foreign and domestic registrant listings). Because electronic registration and
from registration and approximately 30 These estimates are an average of the listing is now mandatory, we believe
manufacturers of plasma derivatives. time it will take manufacturers, respondents have since developed and
We estimate that it will take 1 hour repackers, relabelers, and drug product implemented SOPs consistent with
for registrants to submit initial salvagers, with drug product salvagers meeting the technical format
registration information electronically taking considerably less time than specifications set forth in the
for each new establishment. We also manufacturers. The estimates include regulations and we no longer attribute
estimate that it will take approximately the time for submitting the content of burden to this activity.
30 minutes for each annual review and labeling and other labeling in electronic
update of registration information format. (For drugs subject to an Dated: November 5, 2018.
(including any expedited updates) or approved marketing application, the Leslie Kux,
each review and certification that no electronic submission of the content of Associate Commissioner for Policy.
changes have occurred. The burden labeling under § 314.50(l)(1)(i) is [FR Doc. 2018–24440 Filed 11–7–18; 8:45 am]
hour estimates above are based on our approved under OMB control number BILLING CODE 4164–01–P
familiarity with the amount of time it 0910–0001.) We also estimate that it
takes registrants to input registration will take 45 minutes for each June and
information electronically since June December review and update. These DEPARTMENT OF HEALTH AND
2009. The estimates are an average of estimates represent the average amount HUMAN SERVICES
the time it would take to register a of time to review and update listing
domestic or foreign establishment and information or to review and certify that Food and Drug Administration
an average of the time it would take to no changes have occurred. The [Docket No. FDA–2012–N–0253]
review registration information and estimates include the time for
update several registration items in the submitting any labeling for each drug, Agency Information Collection
database or review registration changes to the drug’s characteristics Activities; Submission for Office of
information and only certify that no submitted for a new NDC, and reports Management and Budget Review;
changes have occurred. of the withdrawal of an approved drug Comment Request; Postmarketing
Based on the number of drugs listed from sale under § 314.81(b)(3)(iii). Adverse Drug and Biological Product
annually since June 2009, we estimate In 2009, to help respondents Experience Reporting and
that approximately 1,713 registrants will transition to the current electronic Recordkeeping
report 12,469 new listings annually reporting requirements, FDA issued the
(including the information submitted to guidance for industry entitled AGENCY: Food and Drug Administration,
obtain a labeler code and to reserve an ‘‘Providing Regulatory Submissions in HHS.
NDC for future use). Electronic Format—Drug Establishment ACTION: Notice.
Based on the number of drugs in our Registration and Drug Listing.’’ The
listing database and the current number document provides guidance to industry SUMMARY: The Food and Drug
of changes to listing information on the statutory requirement to submit Administration (FDA) is announcing
submitted, we estimate 5,300 registrants electronically drug establishment that a proposed collection of
will each report 20 reviews and updates registration and drug listing information has been submitted to the
(including the information submitted to information. The guidance describes the Office of Management and Budget
revise an NDC) for a total of 106,000 types of information to include for (OMB) for review and clearance under
annually. purposes of drug establishment the Paperwork Reduction Act of 1995.
daltland on DSKBBV9HB2PROD with NOTICES

The estimates for the number of drug registration and drug listing and how to DATES: Fax written comments on the
listings include both domestic and prepare and submit the information in collection of information by December
foreign listings, listings submitted by an electronic format (Structured Product 10, 2018.
registrants for products sold under their Labeling (SPL) files) that FDA can ADDRESSES: To ensure that comments on
own names as well as products intended process, review, and archive. The the information collection are received,
for private label distribution, and burden attributed to the guidance OMB recommends that written
information submitted related to an includes the preparation of an SOP for comments be faxed to the Office of

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Document Created: 2018-11-08 06:23:39
Document Modified: 2018-11-08 06:23:39

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.
Dates		Fax written comments on the collection of information by December 10, 2018.
Contact		JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A- 12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, [email protected]
FR Citation		83 FR 55898

83 FR 55898 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 217 (November 8, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration