83_FR_23791 83 FR 23692 - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry: Controlled Correspondence Related to Generic Drug Development

83 FR 23692 - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry: Controlled Correspondence Related to Generic Drug Development

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 99 (May 22, 2018)

Page Range23692-23693
FR Document2018-10856

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 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 controlled correspondence related to generic drug development.

Federal Register, Volume 83 Issue 99 (Tuesday, May 22, 2018) 
[Federal Register Volume 83, Number 99 (Tuesday, May 22, 2018)]
[Notices]
[Pages 23692-23693]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-10856]



[[Page 23692]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-1592]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Guidance for Industry: Controlled Correspondence 
Related to Generic Drug Development

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 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 controlled correspondence 
related to generic drug development.

DATES: Submit either electronic or written comments on the collection 
of information by July 23, 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 July 23, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of July 23, 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-2018-D-1592 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Draft Guidance for Industry: 
Controlled Correspondence Related to Generic Drug Development.'' 
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.thefederalregister.org/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, 
PRAStaff@fda.hhs.gov.

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

[[Page 23693]]

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.

Guidance for Industry: Controlled Correspondence Related to Generic 
Drug Development

OMB Control Number 0910-0797--Extension

    FDA has agreed to specific program enhancements and performance 
goals specified in the Generic Drug User Fee Act Reauthorization (GDUFA 
II) Commitment Letter. One of the performance goals applies to 
controlled correspondence related to generic drug development. The 
GDUFA II Commitment Letter includes details on FDA's commitment to 
respond to questions submitted as controlled correspondence within 
certain timeframes. To support these program goals, we have developed 
the guidance entitled ``Controlled Correspondence Related to Generic 
Drug Development.'' The guidance is intended to facilitate FDA's prompt 
consideration of controlled correspondence and to assist in meeting the 
prescribed timeframes by providing procedural recommendations to 
include the following information in the inquiry: (1) Name, title, 
address, phone number, and entity of the person submitting the inquiry; 
(2) a letter of authorization, if applicable; (3) the FDA-assigned 
control number and submission date of any previous, related controlled 
correspondence that was accepted for substantial review and response, 
if any, as well as a copy of that previous controlled correspondence 
and FDA's response, if any; (4) the relevant reference listed drug(s), 
as applicable, including the application number, proprietary (brand) 
name, manufacturer, active ingredient, dosage form, and strength(s); 
(5) a statement that the controlled correspondence is related to a 
potential abbreviated new drug application (ANDA) submission to the 
Office of Generic Drugs and the ANDA number, if applicable; (6) a 
concise statement of the inquiry; (7) a recommendation of the 
appropriate FDA review discipline; and (8) relevant prior research and 
supporting materials.
    The GDUFA II Commitment Letter also includes details on FDA's 
commitment to respond to requests to clarify ambiguities in FDA's 
controlled correspondence response within certain timeframes. To 
facilitate FDA's prompt consideration of the request and to assist in 
meeting the prescribed timeframes, the guidance recommends including 
the following information in the inquiry: (1) Name, title, address, 
phone number, and entity of the person submitting the inquiry; (2) a 
letter of authorization, if applicable; (3) the FDA-assigned control 
number, submission date of the controlled correspondence on which the 
requestor is seeking clarification, a copy of that previous controlled 
correspondence, and FDA's response to the controlled correspondence; 
and (4) the clarifying questions and the corresponding section(s) of 
FDA's controlled correspondence response on which the requestor is 
seeking clarification. This information collection supports this Agency 
guidance.
    We estimate the burden of the information collection as follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of
              Submission of controlled correspondence                   Number of      responses per     Total annual   Average  burden    Total hours
                                                                       respondents       respondent       responses      per  response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Generic drug manufacturers, related industry, and representatives..             390              3.8            1,496                5            7,480
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    This is the first extension of the information collection and we 
base our estimate on a review of Agency data of fiscal year submissions 
for 2014, 2015, and 2016 which reflects an increase in submissions that 
we attribute to an increase in generic drug development. Accordingly, 
we estimate 390 generic drug manufacturers and related industry (e.g., 
contract research organizations conducting bioanalytical or 
bioequivalence clinical trials) or their representatives will each 
submit an average of 3.8 inquiries annually for a total of 1,496 
inquiries [1,496 / 390 = 3.8]. Information submitted with each inquiry 
varies widely in content, depending on the complexity of the request. 
Inquiries that are defined as controlled correspondence may range from 
a simple inquiry on generic drug labeling to a more complex inquiry for 
a formulation assessment for a specific proposed generic drug product. 
As a result, these inquiries can vary between 1 and 10 burden hours.
    Because the content of inquiries considered controlled 
correspondence is widely varied, we are providing an average burden 
hour for each inquiry. We estimate that it will take an average of 5 
hours per inquiry for industry to gather necessary information, prepare 
the request, and submit the request to FDA. As a result, we estimate 
that it will take an average of 7,480 total hours annually for industry 
to prepare and submit inquiries considered controlled correspondence.

    Dated: May 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-10856 Filed 5-21-18; 8:45 am]
 BILLING CODE 4164-01-P

23692 Federal Register / Vol. 83, No. 99 / Tuesday, May 22, 2018 / Notices DEPARTMENT OF HEALTH AND confidential business information, such information on the cover sheet and not HUMAN SERVICES as a manufacturing process. Please note in the body of your comments and you that if you include your name, contact must identify this information as Food and Drug Administration information, or other information that ‘‘confidential.’’ Any information marked [Docket No. FDA–2018–D–1592] identifies you in the body of your as ‘‘confidential’’ will not be disclosed comments, that information will be except in accordance with 21 CFR 10.20 Agency Information Collection posted on https://www.regulations.gov. and other applicable disclosure law. For Activities; Proposed Collection; • If you want to submit a comment more information about FDA’s posting Comment Request; Guidance for with confidential information that you of comments to public dockets, see 80 Industry: Controlled Correspondence do not wish to be made available to the FR 56469, September 18, 2015, or access Related to Generic Drug Development public, submit the comment as a the information at: https://www.gpo.gov/ written/paper submission and in the fdsys/pkg/FR-2015-09-18/pdf/2015- AGENCY: Food and Drug Administration, manner detailed (see ‘‘Written/Paper 23389.pdf. HHS. Submissions’’ and ‘‘Instructions’’). Docket: For access to the docket to ACTION: Notice. read background documents or the Written/Paper Submissions electronic and written/paper comments SUMMARY: The Food and Drug Submit written/paper submissions as received, go to https:// Administration (FDA, Agency, or we) is follows: www.regulations.gov and insert the announcing an opportunity for public • Mail/Hand delivery/Courier (for docket number, found in brackets in the comment on the proposed collection of written/paper submissions): Dockets certain information by the Agency. heading of this document, into the Management Staff (HFA–305), Food and ‘‘Search’’ box and follow the prompts Under the Paperwork Reduction Act of Drug Administration, 5630 Fishers 1995 (PRA), Federal Agencies are and/or go to the Dockets Management Lane, Rm. 1061, Rockville, MD 20852. Staff, 5630 Fishers Lane, Rm. 1061, required to publish notice in the • For written/paper comments Rockville, MD 20852. Federal Register concerning each submitted to the Dockets Management proposed collection of information, FOR FURTHER INFORMATION CONTACT: Staff, FDA will post your comment, as including each proposed extension of an well as any attachments, except for Domini Bean, Office of Operations, existing collection of information and to information submitted, marked and Food and Drug Administration, Three allow 60 days for public comment in identified, as confidential, if submitted White Flint North, 10A–12M, 11601 response to the notice. This notice as detailed in ‘‘Instructions.’’ Landsdown St, North Bethesda, MD solicits comments on controlled Instructions: All submissions received 20852, 301–796–5733, PRAStaff@ correspondence related to generic drug must include the Docket No. FDA– fda.hhs.gov. development. 2018–D–1592 for ‘‘Agency Information SUPPLEMENTARY INFORMATION: Under the DATES: Submit either electronic or Collection Activities; Proposed PRA (44 U.S.C. 3501–3520), Federal written comments on the collection of Collection; Comment Request; Draft Agencies must obtain approval from the information by July 23, 2018. Guidance for Industry: Controlled Office of Management and Budget ADDRESSES: You may submit comments Correspondence Related to Generic Drug (OMB) for each collection of as follows. Please note that late, Development.’’ Received comments, information they conduct or sponsor. untimely filed comments will not be those filed in a timely manner (see ‘‘Collection of information’’ is defined considered. Electronic comments must ADDRESSES), will be placed in the docket in 44 U.S.C. 3502(3) and 5 CFR be submitted on or before July 23, 2018. and, except for those submitted as 1320.3(c) and includes Agency requests The https://www.regulations.gov ‘‘Confidential Submissions,’’ publicly or requirements that members of the electronic filing system will accept viewable at https://www.regulations.gov public submit reports, keep records, or comments until midnight Eastern Time or at the Dockets Management Staff provide information to a third party. at the end of July 23, 2018. Comments between 9 a.m. and 4 p.m., Monday Section 3506(c)(2)(A) of the PRA (44 received by mail/hand delivery/courier through Friday. U.S.C. 3506(c)(2)(A)) requires Federal (for written/paper submissions) will be • Confidential Submissions—To Agencies to provide a 60-day notice in considered timely if they are submit a comment with confidential the Federal Register concerning each postmarked or the delivery service information that you do not wish to be proposed collection of information, acceptance receipt is on or before that made publicly available, submit your including each proposed extension of an date. comments only as a written/paper existing collection of information, submission. You should submit two before submitting the collection to OMB Electronic Submissions copies total. One copy will include the for approval. To comply with this Submit electronic comments in the information you claim to be confidential requirement, FDA is publishing notice following way: with a heading or cover note that states of the proposed collection of • Federal eRulemaking Portal: ‘‘THIS DOCUMENT CONTAINS information set forth in this document. https://www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ The With respect to the following instructions for submitting comments. Agency will review this copy, including collection of information, FDA invites Comments submitted electronically, the claimed confidential information, in comments on these topics: (1) Whether including attachments, to https:// its consideration of comments. The the proposed collection of information www.regulations.gov will be posted to second copy, which will have the is necessary for the proper performance the docket unchanged. Because your claimed confidential information of FDA’s functions, including whether amozie on DSK3GDR082PROD with NOTICES1 comment will be made public, you are redacted/blacked out, will be available the information will have practical solely responsible for ensuring that your for public viewing and posted on utility; (2) the accuracy of FDA’s comment does not include any https://www.regulations.gov. Submit estimate of the burden of the proposed confidential information that you or a both copies to the Dockets Management collection of information, including the third party may not wish to be posted, Staff. If you do not wish your name and validity of the methodology and such as medical information, your or contact information to be made publicly assumptions used; (3) ways to enhance anyone else’s Social Security number, or available, you can provide this the quality, utility, and clarity of the VerDate Sep<11>2014 16:47 May 21, 2018 Jkt 241001 PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 E:\FR\FM\22MYN1.SGM 22MYN1

Federal Register / Vol. 83, No. 99 / Tuesday, May 22, 2018 / Notices 23693 information to be collected; and (4) FDA’s prompt consideration of The GDUFA II Commitment Letter ways to minimize the burden of the controlled correspondence and to assist also includes details on FDA’s collection of information on in meeting the prescribed timeframes by commitment to respond to requests to respondents, including through the use providing procedural recommendations clarify ambiguities in FDA’s controlled of automated collection techniques, to include the following information in correspondence response within certain when appropriate, and other forms of the inquiry: (1) Name, title, address, timeframes. To facilitate FDA’s prompt information technology. phone number, and entity of the person consideration of the request and to Guidance for Industry: Controlled submitting the inquiry; (2) a letter of assist in meeting the prescribed Correspondence Related to Generic authorization, if applicable; (3) the FDA- timeframes, the guidance recommends Drug Development assigned control number and including the following information in submission date of any previous, related the inquiry: (1) Name, title, address, OMB Control Number 0910–0797— controlled correspondence that was phone number, and entity of the person Extension accepted for substantial review and submitting the inquiry; (2) a letter of FDA has agreed to specific program response, if any, as well as a copy of authorization, if applicable; (3) the FDA- enhancements and performance goals that previous controlled correspondence assigned control number, submission specified in the Generic Drug User Fee and FDA’s response, if any; (4) the date of the controlled correspondence Act Reauthorization (GDUFA II) relevant reference listed drug(s), as on which the requestor is seeking Commitment Letter. One of the applicable, including the application clarification, a copy of that previous performance goals applies to controlled number, proprietary (brand) name, controlled correspondence, and FDA’s correspondence related to generic drug manufacturer, active ingredient, dosage response to the controlled development. The GDUFA II form, and strength(s); (5) a statement correspondence; and (4) the clarifying Commitment Letter includes details on that the controlled correspondence is related to a potential abbreviated new questions and the corresponding FDA’s commitment to respond to drug application (ANDA) submission to section(s) of FDA’s controlled questions submitted as controlled the Office of Generic Drugs and the correspondence response on which the correspondence within certain timeframes. To support these program ANDA number, if applicable; (6) a requestor is seeking clarification. This goals, we have developed the guidance concise statement of the inquiry; (7) a information collection supports this entitled ‘‘Controlled Correspondence recommendation of the appropriate FDA Agency guidance. Related to Generic Drug Development.’’ review discipline; and (8) relevant prior We estimate the burden of the The guidance is intended to facilitate research and supporting materials. information collection as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of Average Number of Total annual Submission of controlled correspondence responses per burden per Total hours respondents responses respondent response Generic drug manufacturers, related industry, and rep- resentatives ...................................................................... 390 3.8 1,496 5 7,480 1 There are no capital costs or operating and maintenance costs associated with this collection of information. This is the first extension of the Because the content of inquiries DEPARTMENT OF HEALTH AND information collection and we base our considered controlled correspondence is HUMAN SERVICES estimate on a review of Agency data of widely varied, we are providing an fiscal year submissions for 2014, 2015, average burden hour for each inquiry. National Institutes of Health and 2016 which reflects an increase in We estimate that it will take an average National Institute on Aging; Notice of submissions that we attribute to an of 5 hours per inquiry for industry to Closed Meeting increase in generic drug development. gather necessary information, prepare Accordingly, we estimate 390 generic the request, and submit the request to Pursuant to section 10(d) of the drug manufacturers and related industry FDA. As a result, we estimate that it will Federal Advisory Committee Act, as (e.g., contract research organizations take an average of 7,480 total hours amended, notice is hereby given of the conducting bioanalytical or annually for industry to prepare and following meeting. bioequivalence clinical trials) or their submit inquiries considered controlled The meeting will be closed to the representatives will each submit an correspondence. public in accordance with the average of 3.8 inquiries annually for a Dated: May 16, 2018. provisions set forth in sections total of 1,496 inquiries [1,496 ÷ 390 = 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Leslie Kux, 3.8]. Information submitted with each as amended. The grant applications and Associate Commissioner for Policy. inquiry varies widely in content, the discussions could disclose [FR Doc. 2018–10856 Filed 5–21–18; 8:45 am] depending on the complexity of the confidential trade secrets or commercial request. Inquiries that are defined as BILLING CODE 4164–01–P property such as patentable material, amozie on DSK3GDR082PROD with NOTICES1 controlled correspondence may range and personal information concerning from a simple inquiry on generic drug individuals associated with the grant labeling to a more complex inquiry for applications, the disclosure of which a formulation assessment for a specific would constitute a clearly unwarranted proposed generic drug product. As a invasion of personal privacy. result, these inquiries can vary between Name of Committee: National Institute on 1 and 10 burden hours. Aging Special Emphasis Panel; Drug VerDate Sep<11>2014 16:47 May 21, 2018 Jkt 241001 PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 E:\FR\FM\22MYN1.SGM 22MYN1


Document Created: 2018-11-02 11:10:08
Document Modified: 2018-11-02 11:10:08
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesSubmit either electronic or written comments on the collection of information by July 23, 2018.
ContactDomini 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]
FR Citation83 FR 23692 
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