83_FR_41237 83 FR 41077 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry: Controlled Correspondence Related to Generic Drug Development

83 FR 41077 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; 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 160 (August 17, 2018)

Page Range41077-41078
FR Document2018-17787

The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

Federal Register, Volume 83 Issue 160 (Friday, August 17, 2018) 
[Federal Register Volume 83, Number 160 (Friday, August 17, 2018)]
[Notices]
[Pages 41077-41078]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-17787]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Guidance for 
Industry: Controlled Correspondence Related to Generic Drug Development

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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 
September 17, 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 [email protected]. All 
comments should be identified with the OMB control number 0910-0797. 
Also include the FDA docket number found in brackets in the heading of 
this document.

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

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.

Guidance for Industry: Controlled Correspondence Related to Generic 
Drug Development

OMB Control Number 0910-0797--Extension

    This information collection supports the above captioned Agency 
guidance. FDA has agreed to specific program enhancements and 
performance goals specified in the Generic Drug User Fee 
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 
document 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 document 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.
    In the Federal Register of May 22, 2018, (83 FR 23692), we 
published a 60-day notice requesting public comment on the proposed 
collection of

[[Page 41078]]

information. No comments were received.
    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. 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 hours annually for industry to 
prepare and submit inquiries considered controlled correspondence.

    Dated: August 10, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-17787 Filed 8-16-18; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 160 / Friday, August 17, 2018 / Notices 41077 line: Live Microbiome-Based Products DEPARTMENT OF HEALTH AND development. The GDUFA II Workshop). HUMAN SERVICES Commitment Letter includes details on FDA’s commitment to respond to SUPPLEMENTARY INFORMATION: Food and Drug Administration questions submitted as controlled I. Background [Docket No. FDA–2018–D–1592] correspondence within certain timeframes. To support these program Live microbiome-based products used Agency Information Collection goals, we have developed the guidance to prevent, treat, or cure a disease or Activities; Submission for Office of entitled ‘‘Controlled Correspondence condition in humans are biological Management and Budget Review; Related to Generic Drug Development.’’ products. There is increasing interest in Comment Request; Guidance for The guidance document is intended to the use of such products for the Industry: Controlled Correspondence facilitate FDA’s prompt consideration of treatment and/or prevention of Related to Generic Drug Development controlled correspondence and to assist conditions such as necrotizing in meeting the prescribed timeframes by AGENCY: Food and Drug Administration, providing procedural recommendations enterocolitis and diarrhea. Historically, HHS. to include the following information in these products have presented with ACTION: Notice. the inquiry: (1) Name, title, address, unique scientific and regulatory phone number, and entity of the person challenges. SUMMARY: The Food and Drug submitting the inquiry; (2) a letter of II. Topics for Discussion at the Public Administration (FDA, Agency, or we) is authorization, if applicable; (3) the FDA- Workshop announcing that a proposed collection assigned control number and of information has been submitted to the submission date of any previous, related The topics for discussion at the public Office of Management and Budget controlled correspondence that was workshop include the clinical, (OMB) for review and clearance under accepted for substantial review and manufacturing, and regulatory the Paperwork Reduction Act of 1995. response, if any, as well as a copy of considerations for live microbiome- DATES: Fax written comments on the that previous controlled correspondence based products to prevent, treat, or cure collection of information by September and FDA’s response, if any; (4) the a disease or condition in humans, and 17, 2018. relevant reference listed drug(s), as the objective is to provide a forum for ADDRESSES: To ensure that comments on applicable, including the application the exchange of information and the information collection are received, number, proprietary (brand) name, perspectives on these topics. OMB recommends that written manufacturer, active ingredient, dosage comments be faxed to the Office of form, and strength(s); (5) a statement III. Participating in the Public Information and Regulatory Affairs, that the controlled correspondence is Workshop OMB, Attn: FDA Desk Officer, Fax: 202– related to a potential abbreviated new 395–7285, or emailed to oira_ drug application (ANDA) submission to Registration: To register for the public the Office of Generic Drugs and the submission@omb.eop.gov. All workshop, please visit the following ANDA number, if applicable; (6) a comments should be identified with the website: https://www.eventbrite.com/e/ concise statement of the inquiry; (7) a OMB control number 0910–0797. Also science-and-regulation-of-live- include the FDA docket number found recommendation of the appropriate FDA microbiome-based-products-used-to- in brackets in the heading of this review discipline; and (8) relevant prior prevent-treat-or-cure-diseases-in-tickets- document. research and supporting materials. 44649072578. Please provide complete The GDUFA II Commitment Letter contact information for each attendee, FOR FURTHER INFORMATION CONTACT: also includes details on FDA’s including name, title, affiliation, Domini Bean, Office of Operations, commitment to respond to requests to address, email, and telephone. Food and Drug Administration, Three clarify ambiguities in FDA’s controlled White Flint North, 10a.m.–12 midnight, correspondence response within certain Registration is free and based on 11601 Landsdown St., North Bethesda, timeframes. To facilitate FDA’s prompt space availability, with priority given to MD 20852, 301–796–5733, PRAStaff@ consideration of the request and to early registrants. Persons interested in fda.hhs.gov. assist in meeting the prescribed attending this public workshop must timeframes, the guidance document SUPPLEMENTARY INFORMATION: In register by August 28, 2018, midnight recommends including the following compliance with 44 U.S.C. 3507, FDA Eastern Time. Early registration is information in the inquiry: (1) Name, has submitted the following proposed recommended because seating is collection of information to OMB for title, address, phone number, and entity limited; therefore, FDA may limit the review and clearance. of the person submitting the inquiry; (2) number of participants from each a letter of authorization, if applicable; organization. There will be no onsite Guidance for Industry: Controlled (3) the FDA-assigned control number, registration. Correspondence Related to Generic submission date of the controlled Drug Development correspondence on which the requestor If you need special accommodations OMB Control Number 0910–0797— is seeking clarification, a copy of that due to a disability, please contact Loni previous controlled correspondence, Warren Henderson or Sherri Revell no Extension and FDA’s response to the controlled later than September 10, 2018 (See FOR This information collection supports correspondence; and (4) the clarifying FURTHER INFORMATION CONTACT). the above captioned Agency guidance. questions and the corresponding amozie on DSK3GDR082PROD with NOTICES1 Dated: August 13, 2018. FDA has agreed to specific program section(s) of FDA’s controlled Leslie Kux, enhancements and performance goals correspondence response on which the specified in the Generic Drug User Fee requestor is seeking clarification. Associate Commissioner for Policy. Reauthorization (GDUFA II) In the Federal Register of May 22, [FR Doc. 2018–17732 Filed 8–16–18; 8:45 am] Commitment Letter. One of the 2018, (83 FR 23692), we published a 60- BILLING CODE 4164–01–P performance goals applies to controlled day notice requesting public comment correspondence related to generic drug on the proposed collection of VerDate Sep<11>2014 17:17 Aug 16, 2018 Jkt 244001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 E:\FR\FM\17AUN1.SGM 17AUN1

41078 Federal Register / Vol. 83, No. 160 / Friday, August 17, 2018 / Notices information. No comments were We estimate the burden of the received. information collection as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of Total Average Number of Total Submission of controlled correspondence responses per annual burden per respondents hours respondent responses 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 DEPARTMENT OF HEALTH AND instructions for submitting comments. information collection. We base our HUMAN SERVICES Comments submitted electronically, estimate on a review of Agency data of including attachments, to https:// Fiscal Year submissions for 2014, 2015, Food and Drug Administration www.regulations.gov will be posted to and 2016, which reflects an increase in [Docket No. FDA–2018–D–2310] the docket unchanged. Because your submissions that we attribute to an comment will be made public, you are increase in generic drug development. Process To Request a Review of Food solely responsible for ensuring that your Accordingly, we estimate 390 generic and Drug Administration’s Decision comment does not include any drug manufacturers and related industry Not To Issue Certain Export confidential information that you or a (e.g., contract research organizations Certificates for Devices; Draft third party may not wish to be posted, conducting bioanalytical or Guidance for Industry and Food and such as medical information, your or bioequivalence clinical trials) or their Drug Administration Staff; Availability anyone else’s Social Security number, or confidential business information, such representatives will each submit an AGENCY: Food and Drug Administration, as a manufacturing process. Please note average of 3.8 inquiries annually for a HHS. that if you include your name, contact total of 1,496 inquiries [1,496 ÷ 390 = ACTION: Notice of availability. information, or other information that 3.8]. Information submitted with each identifies you in the body of your inquiry varies widely in content, SUMMARY: The Food and Drug Administration (FDA or Agency) is comments, that information will be depending on the complexity of the posted on https://www.regulations.gov. request. Inquiries that are defined as announcing the availability of the draft guidance entitled ‘‘Process to Request a • If you want to submit a comment controlled correspondence may range with confidential information that you Review of FDA’s Decision Not to Issue from a simple inquiry on generic drug Certain Export Certificates for Devices; do not wish to be made available to the labeling to a more complex inquiry for Draft Guidance for Industry and Food public, submit the comment as a a formulation assessment for a specific and Drug Administration Staff.’’ FDA is written/paper submission and in the proposed generic drug product. As a issuing this draft guidance to comply manner detailed (see ‘‘Written/Paper result, these inquiries can vary between with changes to the Federal Food, Drug, Submissions’’ and ‘‘Instructions’’). 1 and 10 burden hours. and Cosmetic Act (FD&C Act) as Written/Paper Submissions Because the content of inquiries amended by the FDA Reauthorization considered controlled correspondence is Act of 2017 (FDARA), to specify the Submit written/paper submissions as widely varied, we are providing an process afforded to persons denied a follows: Certificate to Foreign Government (CFG) • Mail/Hand delivery/Courier (for average burden hour for each inquiry. for a device. This draft guidance written/paper submissions): Dockets We estimate that it will take an average describes the information that the Management Staff (HFA–305), Food and of 5 hours per inquiry for industry to Center for Devices and Radiological Drug Administration, 5630 Fishers gather necessary information, prepare Lane, Rm. 1061, Rockville, MD 20852. Health (CDRH) and the Center for the request, and submit the request to • For written/paper comments Biologics Evaluation and Research FDA. As a result, we estimate that it will (CBER) will provide to a person whose submitted to the Dockets Management take an average of 7,480 hours annually request for a CFG for a device is denied, Staff, FDA will post your comment, as for industry to prepare and submit and the process for seeking review of well as any attachments, except for inquiries considered controlled such a denial. This draft guidance is not information submitted, marked and correspondence. final nor is it in effect at this time. identified, as confidential, if submitted Dated: August 10, 2018. DATES: Submit either electronic or as detailed in ‘‘Instructions.’’ Leslie Kux, written comments on the draft guidance Instructions: All submissions received by October 16, 2018 to ensure that the must include the Docket No. FDA– Associate Commissioner for Policy. Agency considers your comment on this 2018–D–2310 for ‘‘Process to Request a [FR Doc. 2018–17787 Filed 8–16–18; 8:45 am] draft guidance before it begins work on Review of FDA’s Decision Not to Issue BILLING CODE 4164–01–P the final version of the guidance. Certain Export Certificates for Devices; ADDRESSES: You may submit comments Draft Guidance for Industry and Food amozie on DSK3GDR082PROD with NOTICES1 on any guidance at any time as follows: and Drug Administration Staff.’’ Received comments will be placed in Electronic Submissions the docket and, except for those Submit electronic comments in the submitted as ‘‘Confidential following way: Submissions,’’ publicly viewable at • Federal eRulemaking Portal: https://www.regulations.gov or at the https://www.regulations.gov. Follow the Dockets Management Staff between 9 VerDate Sep<11>2014 17:17 Aug 16, 2018 Jkt 244001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 E:\FR\FM\17AUN1.SGM 17AUN1


Document Created: 2018-08-17 03:25:48
Document Modified: 2018-08-17 03:25:48
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.
DatesFax written comments on the collection of information by September 17, 2018.
ContactDomini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10a.m.-12 midnight, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, [email protected]
FR Citation83 FR 41077 
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