[Federal Register Volume 83, Number 138 (Wednesday, July 18, 2018)]
[Notices]
[Pages 33934-33938]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-15298]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0742]


Agency Information Collection Activities; Proposed Collection; 
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, Agency, or we) is 
announcing an opportunity for public comment on the proposed collection 
of certain information by the Agency. Under the Paperwork Reduction Act 
of 1995 (PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each extension of an existing collection of information, and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on information collection for drug 
establishment registration and product listing.

DATES: Submit either electronic or written comments on the collection 
of information by September 17, 2018.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before September 17,

[[Page 33935]]

2018. The https://www.regulations.gov electronic filing system will 
accept comments until midnight Eastern Time at the end of September 17, 
2018. Comments received by mail/hand delivery/courier (for written/
paper submissions) will be considered timely if they are postmarked or 
the delivery service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2011-N-0742 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Registration of Producers of 
Drugs and Listing of Drugs in Commercial Distribution.'' Received 
comments, those filed in a timely manner (see ADDRESSES), will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through 
Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

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 (the 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 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,

[[Page 33936]]

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.
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, 
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.
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.
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).
    We estimate the burden of the information collection as follows:

[[Page 33937]]



                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                   Number of
           Activity; 21 CFR section                Number of     responses per   Total annual              Hours per response               Total hours
                                                  respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Initial establishment registration; Sec.  Sec.           1,480               2           2,960  1.......................................           2,960
   207.17, 207.21, 207.25.
Annual review and update of registration                10,000               1          10,000  .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  .75 (45 minutes)........................          79,500
 certification) of listing; Sec.  Sec.
 207.35, 207.57.
Waiver requests; Sec.   207.65................               1               1               1  .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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
 Standard operating procedure (SOP) for creating and       Number of       Number of records     Total annual     Average burden per
               uploading the SPL file                    recordkeepers     per recordkeeper         records          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.

    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 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

[[Page 33938]]

``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.

    Dated: July 12, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-15298 Filed 7-17-18; 8:45 am]
 BILLING CODE 4164-01-P


