Source: https://regulations.justia.com/regulations/fedreg/2018/11/08/2018-24440.html
Timestamp: 2018-11-14 11:22:42
Document Index: 691117254

Matched Legal Cases: ['art 207', 'art 207', 'art 207', '§ 207', 'art 207', '§ 207', 'art 207', '§ 207', '§ 207', '§ 207', '§ 207', '§ 207', 'art 207', '§ 207', '§ 207', '§ 207', 'art 207', '§ 207', '§ 207', '§ 207', '§ 207', '§ 207', '§ 207', '§ 207', '§ 207', '§ 207', '§ 207', '§ 207', '§ 207', '§ 207', '§ 207', '§ 207', '§ 314', '§ 314', '§ 314', 'art 207', 'art\n207', 'art 207', 'art 207', 'art 207', 'art 207', 'art 207']

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, 55898-55900 [2018-24440] :: Food And Drug Administration :: Department Of Health And Human Services :: Regulation Tracker :: Justia
Justia Regulation Tracker Department Of Health And Human Services Food And Drug Administration 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, 55898-55900 [2018-24440]
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, 55898-55900 [2018-24440]
Download as PDF 55898 Federal Register / Vol. 83, No. 217 / Thursday, November 8, 2018 / Notices II. References The following references are on display with the Dockets Management Staff (see ADDRESSES) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; these are not available electronically at https:// www.regulations.gov as these references are copyright protected. 1. Peiser, M., T. Traulau, J. Heidler, et al., ‘‘Allergic Contact Dermatitis: Epidemiology, Molecular Mechanisms, In Vitro Methods and Regulatory Aspects. Current Knowledge Assembled at an International Workshop at BfR, Germany.’’ Cellular and Molecular Life Sciences, 69:763–781, 2012. 2. Westat, Inc. ‘‘An Investigation of Consumers’ Perceptions of Adverse Reactions to Cosmetic Products.’’ Final report submitted to U.S. Department of Health, Education, and Welfare, Food and Drug Administration. June 1975. Dated: November 5, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–24441 Filed 11–7–18; 8:45 am] BILLING CODE 4164–01–P 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. 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 daltland on DSKBBV9HB2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 16:51 Nov 07, 2018 Jkt 247001 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 § 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 § 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 PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 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 § 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 § 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 § 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 § 207.69(b); (b) each importer in the United States of drugs manufactured, repacked, E:\FR\FM\08NON1.SGM 08NON1 Federal Register / Vol. 83, No. 217 / Thursday, November 8, 2018 / Notices 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 § 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 § 207.33. Under § 207.35, registrants must notify us of a change in any of the drug characteristics (except certain identifying information) for an NDC in § 207.33, and assign a new product code and package code for that drug. III. Listing Under Part 207 Under § 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 §§ 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 § 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. 55899 Each registrant must provide the listing information described under § 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 § 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 § 207.53. Registrants who perform only salvaging with respect to a drug must provide the listing information for that drug as required under § 207.54. Additional information may be requested for a listed drug as described in § 207.55. Under § 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 respondents Activity; 21 CFR section(s) Initial establishment registration; §§ 207.17, 207.21, 207.25. Annual review and update of registration information (including expedited updates); § 207.29. Initial listing (including NDC); §§ 207.33, 207.41, 207.45, 207.49, 207.53, 207.54, 207.55. June and December review and update (or certification) of listing; §§ 207.35, 207.57. Waiver requests; § 207.65 ........................................... Public disclosure exemption requests; § 207.81(c) ..... Total ...................................................................... 1 There Number of responses per respondent Average burden per response Total annual responses 1,480 2 2,960 10,000 1 1,713 Total hours 1 2,960 10,000 0.5 (30 minutes) 5,000 7.28 12,470 1.5 18,705 5,300 20 106,000 0.75 (45 minutes) 79,500 1 100 1 1 1 100 ........................ ........................ ........................ 0.5 (30 minutes) 1 1 100 106,266 are no capital or operating and maintenance costs associated with the information collection. daltland on DSKBBV9HB2PROD with NOTICES TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Standard Operating Procedure (SOP) for creating and uploading the Structured Product Labeling file Number of recordkeepers Number of records per recordkeeper Total annual records Average burden per recordkeeping Total hours 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. VerDate Sep<11>2014 16:51 Nov 07, 2018 Jkt 247001 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 E:\FR\FM\08NON1.SGM 08NON1 daltland on DSKBBV9HB2PROD with NOTICES 55900 Federal Register / Vol. 83, No. 217 / Thursday, November 8, 2018 / Notices 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 VerDate Sep<11>2014 16:51 Nov 07, 2018 Jkt 247001 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 § 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 § 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 § 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 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–0253] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Postmarketing Adverse Drug and Biological Product Experience Reporting and Recordkeeping 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. 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 SUMMARY: E:\FR\FM\08NON1.SGM 08NON1
[Federal Register Volume 83, Number 217 (Thursday, November 8, 2018)]
[Pages 55898-55900]
[FR Doc No: 2018-24440]
[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
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
DATES: Fax written comments on the collection of information by
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 [email protected]. 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
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,
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
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 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
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\
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
[[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
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.
[FR Doc. 2018-24440 Filed 11-7-18; 8:45 am]