[Federal Register Volume 86, Number 88 (Monday, May 10, 2021)]
[Notices]
[Pages 24871-24874]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-09805]


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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.

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SUMMARY: The Food and Drug Administration (FDA, we, or Agency) 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 proposed 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 the information collection 
associated with drug establishment registration and product listing 
requirements.

DATES: Submit either electronic or written comments on the collection 
of information by July 9, 2021.

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 July 9, 2021. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of July 9, 2021. 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, 240-402-7500.
     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

[[Page 24872]]

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.govinfo.gov/content/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, 240-402-7500.

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, 
PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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--Revision

    This information collection supports implementation of drug 
establishment registration and listing requirements governed by FDA. 
These requirements 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) and provide for 
electronic submission of information. Agency regulations implementing 
these provisions are found in part 207 (21 CFR part 207) and set forth 
the scope, applicability, and content of information to be included in 
submissions. Except as provided in Sec.  207.65, all information 
submitted under part 207 must be transmitted to FDA in an electronic 
format by using our electronic drug registration and listing system, in 
a form that we can process, review, and archive. For more information 
pertaining to drug establishment registration and listing, we invite 
you to visit our website at: https://www.fda.gov/drugs/drug-approvals-and-databases/drug-establishments-current-registration-site.
    We are revising the information collection to include the 
collection of certain information required by the Coronavirus Aid, 
Relief, and Economic Security (CARES) Act. Section 3112 of the CARES 
Act requires that registrants under section 510 of the FD&C Act must 
annually report the amount of each drug listed that was manufactured, 
prepared, propagated, compounded, or processed for commercial 
distribution. Section 3112(e) also authorizes FDA to require that 
registrants report this information electronically. Finally, section 
3112(e) granted FDA the authority to require that registrants report 
this information at the time a public health emergency is declared.
    To assist respondents to the information collection with the 
current electronic reporting requirements, we issued the guidance 
document entitled ``Providing Regulatory Submissions in Electronic 
Format--Drug Establishment Registration and Drug Listing'' (June 2009), 
available from our website at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-regulatory-submissions-electronic-format-drug-establishment-registration-and-drug-listing. Guidance on the submission of the reporting required in 
section 3112(e) of the CARES Act is included on CDER's 2021 guidance 
agenda available from our website at: https://www.fda.gov/media/134778/download. Agency guidance documents are issued consistent with our good 
guidance practice regulations in 21 CFR 10.115, which provide for 
public comment at any time.
    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. We will accept registration or listing information submitted 
by a private label distributor only if the distributor is acting as an 
authorized agent for and submitting information that pertains to an 
establishment that manufactures, repacks, relabels, or salvages drugs.
    Listing requirements under part 207: Under Sec.  207.41, 
registrants must list each drug that it manufactures, repacks,

[[Page 24873]]

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 in Sec.  207.41(c).
    We estimate the burden of the information collection as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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    Information collection                         Number of
  activity; 21 CFR/statutory       Number of     responses per   Total annual    Average burden     Total hours
           citation               respondents     respondent       responses      per response
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Initial establishment                    1,480               2           2,960  1...............           2,960
 registration; Sec.  Sec.
 207.17, 207.21, and 207.25.
Annual review and update of             10,000               1          10,000  0.5 (30 minutes)           5,000
 registration information
 (including expedited
 updates); Sec.   207.29.
Initial listing (including               1,713            7.28          12,470  1.5.............          18,705
 National Drug Code); Sec.
 Sec.   207.33, 207.41,
 207.45, 207.49, 207.53,
 207.54, and 207.55.
June and December review and             5,300              20         106,000  0.75 (45                  79,500
 update (or certification) of                                                    minutes).
 listing; Sec.  Sec.   207.35
 and 207.57.
Waiver requests; Sec.   207.65               1               1               1  0.5 (30 minutes)               1
Public disclosure exemption                100               1             100  1...............             100
 request; Sec.   207.81(c).
Manufacturing amount                    12,800            22.5         288,000  0.25 (15                  72,000
 information; Section 3112                                                       minutes).
 CARES Act.
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............         419,531  ................         178,266
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


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

    According to internal data, we estimate 1,480 respondents will 
submit 2,960 new establishment registrations annually. We estimate that 
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 drug producers who are not exempt from registration 
and approximately 30 manufacturers of plasma derivatives.
    We assume 1 hour is necessary for registrants to submit initial 
registration information electronically for each new establishment. We 
assume 30 minutes is necessary for each annual review and update of 
registration information (including any expedited updates) or each 
review and certification that no changes have occurred. Our estimate 
reflects the average amount of time and effort necessary to register a 
domestic or foreign establishment, and the average amount of time and 
effort necessary to review and update registration information, or 
review registration information and certify no changes have occurred.
    Based on the number of drugs listed annually since June 2009, we 
estimate 1,713 registrants will report approximately 12,469 new 
listings annually (including the information submitted to obtain a 
labeler code and to reserve a National Drug Code (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 positron emission 
tomography 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 experience with electronically listing submissions 
since June 2009, we assume it takes 1 hour and 30 minutes to submit 
information electronically for each drug listed 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

[[Page 24874]]

considerably less time than manufacturers. The estimates include the 
time for submitting the content of labeling and other labeling in an 
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 assume it takes 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).
    Finally, although we expect most respondents will already have 
prepared a standard operating procedure (SOP) for the electronic 
submission of drug establishment registration and drug listing 
information, we estimate each year additional firms will need to create 
an SOP as recommended in the guidance. We therefore estimate 1,000 
firms will expend approximately 40 hours to prepare, review, and 
approve an SOP, for a total of 40,000 hours annually.
    While we retain the currently approved burden estimates for 
information collection associated with provisions in part 207, we have 
adjusted our estimate upward by 72,000 hours and 288,000 responses to 
account for information collection associated with the new 
manufacturing amount information element required by the CARES Act.

    Dated: May 4, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-09805 Filed 5-7-21; 8:45 am]
BILLING CODE 4164-01-P


