83_FR_46118 83 FR 45942 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry: Formal Meetings Between the Food and Drug Administration and Biosimilar Biological Product Sponsors or Applicants

83 FR 45942 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry: Formal Meetings Between the Food and Drug Administration and Biosimilar Biological Product Sponsors or Applicants

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 176 (September 11, 2018)

Page Range45942-45944
FR Document2018-19674

The Food and Drug Administration (FDA 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 176 (Tuesday, September 11, 2018) 
[Federal Register Volume 83, Number 176 (Tuesday, September 11, 2018)]
[Notices]
[Pages 45942-45944]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-19674]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0286]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Guidance for 
Industry: Formal Meetings Between the Food and Drug Administration and 
Biosimilar Biological Product Sponsors or Applicants

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA 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 October 
11, 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 0910-0802. 
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-12M, 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: Formal Meetings between the Food and Drug 
Administration and Biosimilar Biological Product Sponsors or 
Applicants.
    OMB Control No. 0910-0802--Extension.

[[Page 45943]]

    This information collection supports the above captioned Agency 
guidance. The Biologics Price Competition and Innovation Act of 2009, 
the Biosimilar User Fee Act of 2012, and the recent passage of the 
Biosimilar User Fee Amendments of 2017 (BsUFA II) under Title IV of the 
FDA Reauthorization Act of 2017, authorize user fees for biosimilar 
biological products. FDA has committed to meeting certain performance 
goals in connection with the reauthorized biosimilar user fee program. 
To provide recommendations to industry on formal meetings between FDA 
and sponsors or applicants relating to the development and review of 
biosimilar biological products regulated by the Center for Drug 
Evaluation and Research (CDER) or the Center for Biologics Evaluation 
and Research (CBER) and assist sponsors and applicants in generating 
and submitting meeting requests and the associated meeting packages to 
FDA for biosimilar biological products, we developed guidance for 
industry entitled ``Formal Meetings Between FDA and Biosimilar 
Biological Products Sponsors or Applicants.'' The guidance describes 
our current thinking on how we intend to interpret and apply certain 
provisions of BsUFA II and provides information on specific performance 
goals for the management of meetings associated with the development 
and review of biosimilar biological products. The guidance document 
includes two types of information collection: (1) The submission of a 
meeting request containing certain information and (2) the submission 
of the information package(s) that accompany the meeting request.

A. Request for a Meeting

    Under the guidance, a sponsor or applicant interested in meeting 
with CDER or CBER should submit a meeting request to the sponsor's or 
applicant's application (i.e., investigational new drug application, 
biologics license application). If there is no application, a sponsor 
or applicant should submit the request to either the appropriate CDER 
division director, with a copy sent to the division's chief of project 
management staff, or to the division director of the appropriate 
product office within CBER, but only after first contacting the 
appropriate review division or the Biosimilars Program staff, CDER, 
Office of New Drugs to determine to whom the request should be 
directed, how it should be submitted, and the appropriate format for 
the request and to arrange for confirmation of receipt of the request. 
Under the guidance, FDA requests that sponsors and applicants 
incorporate certain information in the meeting request, including:
    1. Product name,
    2. application number (if applicable), proposed proper name or 
proper name (post licensure),
    4. structure,
    5. reference product name,
    6. proposed indication(s) or context of product development,
    7. meeting type being requested (the rationale for requesting the 
meeting type should be included),
    8. a brief statement of the purpose of the meeting, including a 
brief background of the issues underlying the agenda. It can also 
include a brief summary of completed or planned studies and clinical 
trials or data the sponsor or applicant intends to discuss at the 
meeting, the general nature of the critical questions to be asked, and 
where the meeting fits in the overall development plans.
    9. a list of specific objectives/outcomes expected from the 
meeting,
    10. a proposed agenda, including times required for each agenda 
item,
    11. a list of questions grouped by discipline and a brief 
explanation of the context and purpose of each question,
    12. a list of all individuals with their titles and affiliations 
who will attend the requested meeting from the requestor's organization 
and consultants,
    13. a list of FDA staff, if known, or disciplines asked to 
participate in the requested meeting,
    14. suggested dates and times for the meeting, and
    15. the proposed format of the meeting (i.e., face to face meeting, 
teleconference, or videoconference).
    This information will be used by FDA to determine the utility of 
the meeting, to identify FDA staff necessary to discuss proposed agenda 
items, and to schedule the meeting.

B. Information Package

    FDA requests that a sponsor or applicant submit a meeting package 
to the appropriate review division with the meeting request. FDA 
recommends that the information packages generally include:
    1. Product name and application number (if applicable),
    2. proposed proper name or proper name (post licensure),
    3. structure,
    4. reference product name,
    5. proposed indication(s) or context of product development,
    6. dosage form, route of administration, dosing regimen (frequency 
and duration), and presentation(s),
    7. a list of all sponsor's or applicant's attendees and consultants 
with their titles and affiliations who will attend the requested 
meeting,
    8. background that includes a brief history of the development 
program and the status of product development (e.g., chemistry, 
manufacturing, and controls; nonclinical; and clinical, including any 
development outside the United States, as applicable),
    9. a brief statement summarizing the purpose of the meeting,
    10. the proposed agenda,
    11. a list of questions for discussion grouped by discipline and 
with a brief summary for each question to explain the need or context 
for the question, and
    12. data to support discussion organized by discipline and 
question.
    The purpose of the meeting package is to provide FDA staff the 
opportunity to adequately prepare for the meeting, including the review 
of relevant data concerning the product.
    Description of Respondents: A sponsor or applicant for a biosimilar 
biological product who requests a formal meeting with FDA regarding the 
development and review of a biosimilar biological product.
    In the Federal Register of June 18, 2018 (83 FR 28234), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    We estimate the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
GFI: Formal meetings between FDA                     Number of
    and biosimilar biological        Number of     responses per   Total annual   Average burden    Total hours
 product sponsors or applicants     respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
CDER Meeting Requests...........              36             2.5              89              15           1,335
CBER Meeting Requests...........               2               1               2              15              30
CDER Information Packages.......              29             2.2              64              30           1,920

[[Page 45944]]

 
CBER Information Packages.......               2               2               4              30             120
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           3,405
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Since last OMB approval, there has been an increase in meeting 
requests with CDER and a corresponding increase in the number of 
information packages. Accordingly, we have adjusted our estimate upward 
by six respondents to CDER meeting requests. We attribute this change 
to an increase in biosimilar product development.

    Dated: September 4, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-19674 Filed 9-10-18; 8:45 am]
 BILLING CODE 4164-01-P

45942 Federal Register / Vol. 83, No. 176 / Tuesday, September 11, 2018 / Notices in the body of your comments and you will be posted on FDA’s website after Dated: September 4, 2018. must identify the information as the meeting. Background material is Leslie Kux, ‘‘confidential.’’ Any information marked available at https://www.fda.gov/ Associate Commissioner for Policy. as ‘‘confidential’’ will not be disclosed AdvisoryCommittees/Calendar/ [FR Doc. 2018–19667 Filed 9–10–18; 8:45 am] except in accordance with 21 CFR 10.20 default.htm. Scroll down to the BILLING CODE 4164–01–P and other applicable disclosure law. For appropriate advisory committee meeting more information about FDA’s posting link. of comments to public dockets, see 80 DEPARTMENT OF HEALTH AND Procedure: Interested persons may FR 56469, September 18, 2015, or access HUMAN SERVICES present data, information, or views, the information at: https://www.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/2015- orally or in writing, on issues pending Food and Drug Administration 23389.pdf . before the committee. All electronic and written submissions submitted to the [Docket No. FDA–2013–D–0286] Docket: For access to the docket to read background documents or the Docket (see ADDRESSES) on or before Agency Information Collection electronic and written/paper comments October 3, 2018, will be provided to the Activities; Submission for Office of received, go to https:// committee. Oral presentations from the Management and Budget Review; www.regulations.gov and insert the public will be scheduled between Comment Request; Guidance for docket number, found in brackets in the approximately 1 p.m. and 2 p.m. Those Industry: Formal Meetings Between the heading of this document, into the individuals interested in making formal Food and Drug Administration and ‘‘Search’’ box and follow the prompts oral presentations should notify the Biosimilar Biological Product and/or go to the Dockets Management contact person and submit a brief Sponsors or Applicants Staff, 5630 Fishers Lane, Rm. 1061, statement of the general nature of the Rockville, MD 20852. evidence or arguments they wish to AGENCY: Food and Drug Administration, FOR FURTHER INFORMATION CONTACT: present, the names and addresses of HHS. Moon Hee V. Choi, Center for Drug proposed participants, and an ACTION: Notice. Evaluation and Research, Food and indication of the approximate time SUMMARY: The Food and Drug Drug Administration, 10903 New requested to make their presentation on Administration (FDA or we) is Hampshire Ave., Bldg. 31, Rm. 2417, or before September 25, 2018. Time announcing that a proposed collection Silver Spring, MD 20993–0002, 301– allotted for each presentation may be of information has been submitted to the 796–9001, Fax: 301–847–8533, email: limited. If the number of registrants Office of Management and Budget AADPAC@fda.hhs.gov, or FDA requesting to speak is greater than can (OMB) for review and clearance under Advisory Committee Information Line, be reasonably accommodated during the the Paperwork Reduction Act of 1995. 1–800–741–8138 (301–443–0572 in the scheduled open public hearing session, DATES: Fax written comments on the Washington, DC area). A notice in the FDA may conduct a lottery to determine collection of information by October 11, Federal Register about last minute the speakers for the scheduled open 2018. modifications that impact a previously public hearing session. The contact ADDRESSES: To ensure that comments on announced advisory committee meeting person will notify interested persons cannot always be published quickly regarding their request to speak by the information collection are received, enough to provide timely notice. OMB recommends that written September 26, 2018. Therefore, you should always check the comments be faxed to the Office of Persons attending FDA’s advisory Information and Regulatory Affairs, FDA’s website at https://www.fda.gov/ committee meetings are advised that AdvisoryCommittees/default.htm and OMB, Attn: FDA Desk Officer, Fax: 202– FDA is not responsible for providing 395–7285, or emailed to oira_ scroll down to the appropriate advisory access to electrical outlets. committee meeting link, or call the submission@omb.eop.gov. All advisory committee information line to For press inquiries, please contact the comments should be identified with the learn about possible modifications Office of Media Affairs at fdaoma@ OMB control number 0910–0802. Also before coming to the meeting. fda.hhs.gov or 301–796–4540. include the FDA docket number found in brackets in the heading of this SUPPLEMENTARY INFORMATION: FDA welcomes the attendance of the document. Agenda: The committee will be asked public at its advisory committee to discuss new drug application (NDA) meetings and will make every effort to FOR FURTHER INFORMATION CONTACT: 210730, for oliceridine 1 milligram/ accommodate persons with disabilities. Domini Bean, Office of Operations, milliliter injection, submitted by If you require accommodations due to a Food and Drug Administration, Three Trevena, Inc., for the management of disability, please contact Moon Hee V. White Flint North, 10A–12M, 11601 moderate-to-severe acute pain in adult Choi (see FOR FURTHER INFORMATION Landsdown St., North Bethesda, MD patients for whom an intravenous CONTACT) at least 7 days in advance of 20852, 301–796–5733, PRAStaff@ opioid is warranted. The committee will the meeting. fda.hhs.gov. also be asked to discuss the efficacy and SUPPLEMENTARY INFORMATION: In FDA is committed to the orderly safety data and benefit-risk compliance with 44 U.S.C. 3507, FDA conduct of its advisory committee considerations. has submitted the following proposed meetings. Please visit our website at FDA intends to make background collection of information to OMB for material available to the public no later https://www.fda.gov/Advisory review and clearance. daltland on DSKBBV9HB2PROD with NOTICES than 2 business days before the meeting. Committees/AboutAdvisoryCommittees/ Guidance for Industry: Formal If FDA is unable to post the background ucm111462.htm for procedures on Meetings between the Food and Drug material on its website prior to the public conduct during advisory Administration and Biosimilar meeting, the background material will committee meetings. Biological Product Sponsors or be made publicly available at the Notice of this meeting is given under Applicants. location of the advisory committee the Federal Advisory Committee Act (5 OMB Control No. 0910–0802— meeting, and the background material U.S.C. app. 2). Extension. VerDate Sep<11>2014 18:49 Sep 10, 2018 Jkt 244001 PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 E:\FR\FM\11SEN1.SGM 11SEN1

Federal Register / Vol. 83, No. 176 / Tuesday, September 11, 2018 / Notices 45943 This information collection supports contacting the appropriate review B. Information Package the above captioned Agency guidance. division or the Biosimilars Program FDA requests that a sponsor or The Biologics Price Competition and staff, CDER, Office of New Drugs to applicant submit a meeting package to Innovation Act of 2009, the Biosimilar determine to whom the request should the appropriate review division with the User Fee Act of 2012, and the recent be directed, how it should be submitted, meeting request. FDA recommends that passage of the Biosimilar User Fee and the appropriate format for the the information packages generally Amendments of 2017 (BsUFA II) under request and to arrange for confirmation include: Title IV of the FDA Reauthorization Act of receipt of the request. Under the of 2017, authorize user fees for 1. Product name and application guidance, FDA requests that sponsors biosimilar biological products. FDA has number (if applicable), and applicants incorporate certain committed to meeting certain information in the meeting request, 2. proposed proper name or proper performance goals in connection with including: name (post licensure), the reauthorized biosimilar user fee 1. Product name, 3. structure, program. To provide recommendations 2. application number (if applicable), 4. reference product name, to industry on formal meetings between proposed proper name or proper name 5. proposed indication(s) or context of FDA and sponsors or applicants relating (post licensure), product development, to the development and review of 4. structure, 6. dosage form, route of biosimilar biological products regulated 5. reference product name, administration, dosing regimen by the Center for Drug Evaluation and 6. proposed indication(s) or context of (frequency and duration), and Research (CDER) or the Center for product development, presentation(s), Biologics Evaluation and Research 7. meeting type being requested (the 7. a list of all sponsor’s or applicant’s (CBER) and assist sponsors and rationale for requesting the meeting type attendees and consultants with their applicants in generating and submitting should be included), titles and affiliations who will attend meeting requests and the associated 8. a brief statement of the purpose of the requested meeting, meeting packages to FDA for biosimilar the meeting, including a brief 8. background that includes a brief biological products, we developed background of the issues underlying the history of the development program and guidance for industry entitled ‘‘Formal agenda. It can also include a brief the status of product development (e.g., Meetings Between FDA and Biosimilar summary of completed or planned chemistry, manufacturing, and controls; Biological Products Sponsors or studies and clinical trials or data the nonclinical; and clinical, including any Applicants.’’ The guidance describes sponsor or applicant intends to discuss development outside the United States, our current thinking on how we intend at the meeting, the general nature of the as applicable), to interpret and apply certain provisions critical questions to be asked, and where 9. a brief statement summarizing the of BsUFA II and provides information purpose of the meeting, the meeting fits in the overall on specific performance goals for the 10. the proposed agenda, development plans. management of meetings associated 11. a list of questions for discussion 9. a list of specific objectives/ with the development and review of grouped by discipline and with a brief outcomes expected from the meeting, biosimilar biological products. The summary for each question to explain 10. a proposed agenda, including guidance document includes two types the need or context for the question, and of information collection: (1) The times required for each agenda item, 11. a list of questions grouped by 12. data to support discussion submission of a meeting request organized by discipline and question. containing certain information and (2) discipline and a brief explanation of the context and purpose of each question, The purpose of the meeting package is the submission of the information 12. a list of all individuals with their to provide FDA staff the opportunity to package(s) that accompany the meeting titles and affiliations who will attend adequately prepare for the meeting, request. the requested meeting from the including the review of relevant data A. Request for a Meeting requestor’s organization and concerning the product. Under the guidance, a sponsor or consultants, Description of Respondents: A applicant interested in meeting with 13. a list of FDA staff, if known, or sponsor or applicant for a biosimilar CDER or CBER should submit a meeting disciplines asked to participate in the biological product who requests a request to the sponsor’s or applicant’s requested meeting, formal meeting with FDA regarding the application (i.e., investigational new 14. suggested dates and times for the development and review of a biosimilar drug application, biologics license meeting, and biological product. application). If there is no application, 15. the proposed format of the In the Federal Register of June 18, a sponsor or applicant should submit meeting (i.e., face to face meeting, 2018 (83 FR 28234), we published a 60- the request to either the appropriate teleconference, or videoconference). day notice requesting public comment CDER division director, with a copy This information will be used by FDA on the proposed collection of sent to the division’s chief of project to determine the utility of the meeting, information. No comments were management staff, or to the division to identify FDA staff necessary to received. director of the appropriate product discuss proposed agenda items, and to We estimate the burden of this office within CBER, but only after first schedule the meeting. collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 daltland on DSKBBV9HB2PROD with NOTICES Number of Total Average GFI: Formal meetings between FDA and biosimilar Number of responses per annual burden per Total hours biological product sponsors or applicants respondents respondent responses response CDER Meeting Requests ..................................................... 36 2.5 89 15 1,335 CBER Meeting Requests ..................................................... 2 1 2 15 30 CDER Information Packages ............................................... 29 2.2 64 30 1,920 VerDate Sep<11>2014 18:49 Sep 10, 2018 Jkt 244001 PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 E:\FR\FM\11SEN1.SGM 11SEN1

45944 Federal Register / Vol. 83, No. 176 / Tuesday, September 11, 2018 / Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued Number of Total Average GFI: Formal meetings between FDA and biosimilar Number of responses per annual burden per Total hours biological product sponsors or applicants respondents respondent responses response CBER Information Packages ............................................... 2 2 4 30 120 Total .............................................................................. ........................ ........................ ........................ ........................ 3,405 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Since last OMB approval, there has synthetic manufacturing process information submitted, marked and been an increase in meeting requests changes; changes in the source of drug identified, as confidential, if submitted with CDER and a corresponding substance; and change to container as detailed in ‘‘Instructions.’’ increase in the number of information closure system of the drug substance. Instructions: All submissions received packages. Accordingly, we have DATES: Submit either electronic or must include the Docket No. FDA– adjusted our estimate upward by six written comments on the draft guidance 2018–D–3151 for ‘‘Postapproval respondents to CDER meeting requests. by November 13, 2018 to ensure that the Changes to Drug Substances.’’ Received We attribute this change to an increase Agency considers your comment on this comments will be placed in the docket in biosimilar product development. draft guidance before it begins work on and, except for those submitted as Dated: September 4, 2018. the final version of the guidance. ‘‘Confidential Submissions,’’ publicly Leslie Kux, ADDRESSES: You may submit comments viewable at https://www.regulations.gov on any guidance at any time as follows: or at the Dockets Management Staff Associate Commissioner for Policy. between 9 a.m. and 4 p.m., Monday [FR Doc. 2018–19674 Filed 9–10–18; 8:45 am] Electronic Submissions through Friday. BILLING CODE 4164–01–P Submit electronic comments in the • Confidential Submissions—To following way: submit a comment with confidential DEPARTMENT OF HEALTH AND • Federal eRulemaking Portal: information that you do not wish to be https://www.regulations.gov. Follow the made publicly available, submit your HUMAN SERVICES comments only as a written/paper instructions for submitting comments. Food and Drug Administration Comments submitted electronically, submission. You should submit two including attachments, to https:// copies total. One copy will include the [Docket No. FDA–2018–D–3151] www.regulations.gov will be posted to information you claim to be confidential the docket unchanged. Because your with a heading or cover note that states Postapproval Changes to Drug ‘‘THIS DOCUMENT CONTAINS Substances; Draft Guidance for comment will be made public, you are solely responsible for ensuring that your CONFIDENTIAL INFORMATION.’’ The Industry; Availability Agency will review this copy, including comment does not include any AGENCY: Food and Drug Administration, confidential information that you or a the claimed confidential information, in HHS. third party may not wish to be posted, its consideration of comments. The ACTION: Notice of availability. such as medical information, your or second copy, which will have the anyone else’s Social Security number, or claimed confidential information SUMMARY: The Food and Drug confidential business information, such redacted/blacked out, will be available Administration (FDA or Agency) is as a manufacturing process. Please note for public viewing and posted on announcing the availability of a draft that if you include your name, contact https://www.regulations.gov. Submit guidance for industry entitled information, or other information that both copies to the Dockets Management ‘‘Postapproval Changes to Drug identifies you in the body of your Staff. If you do not wish your name and Substances.’’ This draft guidance comments, that information will be contact information to be made publicly provides recommendations to holders of posted on https://www.regulations.gov. available, you can provide this approved new drug applications, • If you want to submit a comment information on the cover sheet and not abbreviated new drug applications, new with confidential information that you in the body of your comments and you animal drug applications, abbreviated do not wish to be made available to the must identify this information as new animal drug applications, and public, submit the comment as a ‘‘confidential.’’ Any information marked holders of drug master files and written/paper submission and in the as ‘‘confidential’’ will not be disclosed veterinary master files who may want to manner detailed (see ‘‘Written/Paper except in accordance with 21 CFR 10.20 make a change to the drug substance Submissions’’ and ‘‘Instructions’’). and other applicable disclosure law. For manufacturing process during the drug more information about FDA’s posting product application postapproval Written/Paper Submissions of comments to public dockets, see 80 period. The draft guidance applies to Submit written/paper submissions as FR 56469, September 18, 2015, or access synthetic drug substances and the follows: the information at: https://www.gpo.gov/ synthetic steps involved in the • Mail/Hand delivery/Courier (for fdsys/pkg/FR-2015-09-18/pdf/2015- preparation of semisynthetic drug written/paper submissions): Dockets 23389.pdf. daltland on DSKBBV9HB2PROD with NOTICES substances. The draft guidance covers Management Staff (HFA–305), Food and Docket: For access to the docket to facility, scale, and equipment changes Drug Administration, 5630 Fishers read background documents or the associated with all steps of drug Lane, Rm. 1061, Rockville, MD 20852. electronic and written/paper comments substance manufacturing; specification • For written/paper comments received, go to https:// changes to starting materials, raw submitted to the Dockets Management www.regulations.gov and insert the materials, intermediates, and the Staff, FDA will post your comment, as docket number, found in brackets in the unfinished and final drug substance; well as any attachments, except for heading of this document, into the VerDate Sep<11>2014 18:49 Sep 10, 2018 Jkt 244001 PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 E:\FR\FM\11SEN1.SGM 11SEN1


Document Created: 2018-09-11 01:02:12
Document Modified: 2018-09-11 01:02:12
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 October 11, 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 45942 
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