82 FR 36797 - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 150 (August 7, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 150 (August 7, 2017)
| Page Range | 36797-36799 | |
| FR Document | 2017-16564 |
[Federal Register Volume 82, Number 150 (Monday, August 7, 2017)] [Notices] [Pages 36797-36799] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-16564] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0085] Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics 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 the proposed extension of the collection of information concerning cooperative manufacturing arrangements for licensed biologics. DATES: Submit either electronic or written comments on the collection of information by October 6, 2017. 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 October 6, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of October 6, 2017. 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, [[Page 36798]] 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-0085 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics.'' 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, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3850, [email protected]. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics OMB Control Number 0910-0629--Extension This information collection supports the Agency guidance document entitled, ``Guidance for Industry: Cooperative Manufacturing for Licensed Biologics.'' The guidance document provides information concerning cooperative manufacturing arrangements applicable to biological products subject to licensure under section 351 of the Public Health Service Act (42 U.S.C. 262). The guidance addresses several types of manufacturing arrangements (i.e., short supply arrangements, divided manufacturing arrangements, shared manufacturing arrangements, and contract manufacturing arrangements) and describes certain reporting and recordkeeping responsibilities associated with these arrangements, including the following: (1) Notification of all important proposed changes to production and facilities; (2) notification of results of tests and investigations regarding or possibly impacting the product; (3) notification of products manufactured in a contract facility; and (4) standard operating procedures. 1. Notification of All Important Proposed Changes to Production and Facilities Each licensed manufacturer in a divided manufacturing arrangement or shared manufacturing arrangement must notify the appropriate FDA Center regarding proposed changes in the manufacture, testing, or specifications of its product, in accordance with Sec. 601.12 (21 CFR 601.12). In the guidance, we recommend that each licensed manufacturer that proposes such a change should also inform other participating licensed manufacturer(s) of the proposed change. For contract manufacturing arrangements, we recommend that the contract manufacturer should share with the license manufacturer all important proposed changes to production and facilities (including introduction of new products or at inspection). The license holder is responsible for reporting these changes to FDA (21 CFR 601.12). [[Page 36799]] 2. Notification of Results of Tests and Investigations Regarding or Possibly Impacting the Product In the guidance, we recommend the following for contract manufacturing arrangements: The contract manufacturer should fully inform the license manufacturer of the results of all tests and investigations regarding or possibly having an impact on the product; and The license manufacturer should obtain assurance from the contractor that any FDA list of inspectional observations will be shared with the license manufacturer to allow evaluation of its impact on the purity, potency, and safety of the license manufacturer's product. 3. Notification of Products Manufactured in a Contract Facility In the guidance, we recommend for contract manufacturing arrangements that a license manufacturer cross reference a contract manufacturing facility's master files only in circumstances involving certain proprietary information of the contract manufacturer, such as a list of all products manufactured in a contract facility. In this situation, the license manufacturer should be kept informed of the types or categories of all products manufactured in the contract facility. 4. Standard Operating Procedures In the guidance, we remind the license manufacturer that the license manufacturer assumes responsibility for compliance with the applicable product and establishment standards (21 CFR 600.3(t)). Therefore, if the license manufacturer enters into an agreement with a contract manufacturing facility, the license manufacturer must ensure that the facility complies with the applicable standards. An agreement between a license manufacturer and a contract manufacturing facility normally includes procedures to regularly assess the contract manufacturing facility's compliance. These procedures may include, but are not limited to, review of records and manufacturing deviations and defects, and periodic audits. For shared manufacturing arrangements, each manufacturer must submit a separate biologics license application describing the manufacturing facilities and operations applicable to the preparation of that manufacturer's biological substance or product (Sec. 601.2(a)). In the guidance, we state that we expect the manufacturer that prepares, or is responsible for the preparation of, the product in final form for commercial distribution to assume primary responsibility for providing data demonstrating the safety, purity, and potency of the final product. We also state that we expect the licensed finished product manufacturer to be primarily responsible for any postapproval obligations, such as postmarketing clinical trials, additional product stability studies, complaint handling, recalls, postmarket reporting of the dissemination of advertising and promotional labeling materials as required under Sec. 601.12(f)(4), and adverse experience reporting. We recommend that the final product manufacturer establish a procedure with the other participating manufacturer(s) to obtain information in these areas. Description of Respondents: Respondents to the information collection are participating licensed manufacturers, final product manufacturers, and contract manufacturers associated with cooperative manufacturing arrangements subject to the associated regulations discussed in the guidance. Burden Estimate: We believe that the information collection provisions in the guidance do not create a new burden for respondents. We believe the reporting and recordkeeping provisions are part of usual and customary business practices. Licensed manufacturers would have contractual agreements with participating licensed manufacturers, final product manufacturers, and contract manufacturers, as applicable for the type of cooperative manufacturing arrangement, to address all these information collection provisions. The guidance also refers to previously approved collections of information found in FDA regulations at parts 201, 207, 211, 600, 601, 606, 607, 610, 660, 801, 803, 807, 809, and 820 (21 CFR parts 201, 207, 211, 600, 601, 606, 607, 610, 660, 801, 803, 807, 809, and 820). The collections of information in parts 606 and 610 have been approved under OMB control numbers 0910-0116, 0910-0458, and 0910-0206; part 600 has been approved under OMB control numbers 0910-0308 and 0910-0458; parts 601 and 660 have been approved under OMB control number 0910- 0338; part 803 has been approved under OMB control number 0910-0437; part 211 has been approved under OMB control number 0910-0139; part 820 has been approved under OMB control number 0910-0073; parts 207, 607, and 807 have been approved under OMB control numbers 0910-0045, 0910- 0052, and 0910-0625; and parts 201, 801, and 809 have been approved under OMB control numbers 0910-0537, 0910-0572, and 0910-0485. Dated: August 2, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-16564 Filed 8-4-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 150 / Monday, August 7, 2017 / Notices 36797
ADDRESSES: FDA White Oak Campus, be scheduled between approximately DEPARTMENT OF HEALTH AND
10903 New Hampshire Ave., Bldg. 31 1:30 p.m. and 2:30 p.m. Those HUMAN SERVICES
Conference Center, the Great Room (Rm. individuals interested in making formal
1503), Silver Spring, MD 20993–0002. oral presentations should notify the Food and Drug Administration
Answers to commonly asked questions contact person and submit a brief [Docket No. FDA–2011–N–0085]
including information regarding special statement of the general nature of the
accommodations due to a disability, evidence or arguments they wish to Agency Information Collection
visitor parking, and transportation may present, the names and addresses of Activities; Proposed Collection;
be accessed at: https://www.fda.gov/ proposed participants, and an Comment Request; Guidance for
AdvisoryCommittees/AboutAdvisory indication of the approximate time Industry: Cooperative Manufacturing
Committees/ucm408555.htm. Arrangements for Licensed Biologics
requested to make their presentation on
FOR FURTHER INFORMATION CONTACT:
or before August 29, 2017. Time allotted AGENCY: Food and Drug Administration,
Serina Hunter-Thomas or Rosanna for each presentation may be limited. If HHS.
Harvey, Center for Biologics Evaluation
the number of registrants requesting to ACTION: Notice.
and Research, Food and Drug
speak is greater than can be reasonably
Administration, 10903 New Hampshire SUMMARY: The Food and Drug
Ave., Bldg. 71, Rm. 6307C, Silver accommodated during the scheduled
open public hearing session, FDA may Administration (FDA, Agency, or we) is
Spring, MD 20993–0002; 240–402–5771, announcing an opportunity for public
serina.hunter-thomas@fda.hhs.gov and conduct a lottery to determine the
speakers for the scheduled open public comment on the proposed collection of
240–402–8072, rosanna.harvey@ certain information by the Agency.
fda.hhs.gov; or FDA Advisory hearing session. The contact person will
Under the Paperwork Reduction Act of
Committee Information Line, 1–800– notify interested persons regarding their 1995 (PRA), Federal Agencies are
741–8138 (301–443–0572 in the request to speak by August 30, 2017. required to publish notice in the
Washington, DC area). A notice in the Web cast: For those unable to attend Federal Register concerning each
Federal Register about last minute in person, the meeting will also be web proposed collection of information,
modifications that impact a previously cast and will be available at the including each proposed extension of an
announced advisory committee meeting following link: https:// existing collection of information, and
cannot always be published quickly collaboration.fda.gov/vrbpac0917/. to allow 60 days for public comment in
enough to provide timely notice. response to the notice. This notice
Therefore, you should always check the Persons attending FDA’s advisory
committee meetings are advised that the solicits comments on the proposed
Agency’s Web site at https:// extension of the collection of
www.fda.gov/AdvisoryCommittees/ Agency is not responsible for providing
information concerning cooperative
default.htm and scroll down to the access to electrical outlets.
manufacturing arrangements for
appropriate advisory committee meeting FDA welcomes the attendance of the licensed biologics.
link, or call the advisory committee public at its advisory committee DATES: Submit either electronic or
information line to learn about possible meetings and will make every effort to written comments on the collection of
modifications before coming to the accommodate persons with disabilities. information by October 6, 2017.
meeting. If you require accommodations due to a ADDRESSES: You may submit comments
SUPPLEMENTARY INFORMATION: disability, please contact Serina Hunter- as follows. Please note that late,
Agenda: On September 13, 2017, the Thomas at least 7 days in advance of the untimely filed comments will not be
VRBPAC will meet in an open session meeting. considered. Electronic comments must
to discuss and make recommendations FDA is committed to the orderly be submitted on or before October 6,
on the safety and effectiveness of Zoster 2017. The https://www.regulations.gov
conduct of its advisory committee
Vaccine Recombinant, Adjuvanted, electronic filing system will accept
meetings. Please visit our Web site at:
manufactured by GlaxoSmithKline comments until midnight Eastern Time
https://www.fda.gov/Advisory
Biologicals. FDA intends to make at the end of October 6, 2017. Comments
background material available to the Committees/AboutAdvisoryCommittees/
ucm111462.htm for procedures on received by mail/hand delivery/courier
public no later than 2 business days (for written/paper submissions) will be
before the meeting. If FDA is unable to public conduct during advisory
considered timely if they are
post the background material on its Web committee meetings.
postmarked or the delivery service
site prior to the meeting, the background Notice of this meeting is given under acceptance receipt is on or before that
material will be made publicly available the Federal Advisory Committee Act (5 date.
at the location of the advisory U.S.C. app. 2).
committee meeting, and the background Electronic Submissions
Dated: August 1, 2017.
material will be posted on FDA’s Web Submit electronic comments in the
site after the meeting. Background Anna K. Abram, following way:
material is available at https:// Deputy Commissioner for Policy, Planning, • Federal eRulemaking Portal:
www.fda.gov/AdvisoryCommittees/ Legislation, and Analysis. https://www.regulations.gov. Follow the
Calendar/default.htm. Scroll down to [FR Doc. 2017–16519 Filed 8–4–17; 8:45 am] instructions for submitting comments.
the appropriate advisory committee BILLING CODE 4164–01–P Comments submitted electronically,
meeting link. including attachments, to https://
mstockstill on DSK30JT082PROD with NOTICES
Procedure: Interested persons may www.regulations.gov will be posted to
present data, information, or views, the docket unchanged. Because your
orally or in writing, on issues pending comment will be made public, you are
before the committee. Written solely responsible for ensuring that your
submissions may be made to the contact comment does not include any
person on or before September 6, 2017. confidential information that you or a
Oral presentations from the public will third party may not wish to be posted,
VerDate Sep<11>2014 18:14 Aug 04, 2017 Jkt 241001 PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 E:\FR\FM\07AUN1.SGM 07AUN1](https://thefederalregister.org/doc/82_FR_36947/page/1.svg)
![Federal Register / Vol. 82, No. 150 / Monday, August 7, 2017 / Notices 36799
2. Notification of Results of Tests and primary responsibility for providing Dated: August 2, 2017.
Investigations Regarding or Possibly data demonstrating the safety, purity, Anna K. Abram,
Impacting the Product and potency of the final product. We Deputy Commissioner for Policy, Planning,
In the guidance, we recommend the also state that we expect the licensed Legislation, and Analysis.
following for contract manufacturing finished product manufacturer to be [FR Doc. 2017–16564 Filed 8–4–17; 8:45 am]
primarily responsible for any
arrangements: BILLING CODE 4164–01–P
postapproval obligations, such as
• The contract manufacturer should
postmarketing clinical trials, additional
fully inform the license manufacturer of
product stability studies, complaint DEPARTMENT OF HEALTH AND
the results of all tests and investigations
handling, recalls, postmarket reporting HUMAN SERVICES
regarding or possibly having an impact
of the dissemination of advertising and
on the product; and Food and Drug Administration
promotional labeling materials as
• The license manufacturer should
required under § 601.12(f)(4), and [Docket No. FDA–2010–N–0110]
obtain assurance from the contractor
adverse experience reporting. We
that any FDA list of inspectional
recommend that the final product Agency Information Collection
observations will be shared with the manufacturer establish a procedure with
license manufacturer to allow Activities; Submission for Office of
the other participating manufacturer(s) Management and Budget Review;
evaluation of its impact on the purity, to obtain information in these areas.
potency, and safety of the license Comment Request; Prescription Drug
Description of Respondents: Advertisements
manufacturer’s product. Respondents to the information
3. Notification of Products collection are participating licensed AGENCY: Food and Drug Administration,
Manufactured in a Contract Facility manufacturers, final product HHS.
manufacturers, and contract ACTION: Notice.
In the guidance, we recommend for manufacturers associated with
contract manufacturing arrangements cooperative manufacturing SUMMARY: The Food and Drug
that a license manufacturer cross arrangements subject to the associated Administration (FDA) is announcing
reference a contract manufacturing regulations discussed in the guidance. that a proposed collection of
facility’s master files only in Burden Estimate: We believe that the information has been submitted to the
circumstances involving certain information collection provisions in the Office of Management and Budget
proprietary information of the contract guidance do not create a new burden for (OMB) for review and clearance under
manufacturer, such as a list of all respondents. We believe the reporting the Paperwork Reduction Act of 1995.
products manufactured in a contract and recordkeeping provisions are part of DATES: Fax written comments on the
facility. In this situation, the license usual and customary business practices. collection of information by September
manufacturer should be kept informed Licensed manufacturers would have 6, 2017.
of the types or categories of all products contractual agreements with ADDRESSES: To ensure that comments on
manufactured in the contract facility. participating licensed manufacturers, the information collection are received,
4. Standard Operating Procedures final product manufacturers, and OMB recommends that written
contract manufacturers, as applicable comments be faxed to the Office of
In the guidance, we remind the for the type of cooperative Information and Regulatory Affairs,
license manufacturer that the license manufacturing arrangement, to address OMB, Attn: FDA Desk Officer, FAX:
manufacturer assumes responsibility for all these information collection 202–395–7285, or emailed to oira_
compliance with the applicable product provisions. submission@omb.eop.gov. All
and establishment standards (21 CFR The guidance also refers to previously comments should be identified with the
600.3(t)). Therefore, if the license approved collections of information OMB control number 0910–0686. Also
manufacturer enters into an agreement found in FDA regulations at parts 201, include the FDA docket number found
with a contract manufacturing facility, 207, 211, 600, 601, 606, 607, 610, 660, in brackets in the heading of this
the license manufacturer must ensure 801, 803, 807, 809, and 820 (21 CFR document.
that the facility complies with the parts 201, 207, 211, 600, 601, 606, 607,
applicable standards. An agreement 610, 660, 801, 803, 807, 809, and 820). FOR FURTHER INFORMATION CONTACT:
between a license manufacturer and a The collections of information in parts Domini Bean, Office of Operations,
contract manufacturing facility normally 606 and 610 have been approved under Food and Drug Administration, Three
includes procedures to regularly assess OMB control numbers 0910–0116, White Flint North, 10A63, 11601
the contract manufacturing facility’s 0910–0458, and 0910–0206; part 600 Landsdown St., North Bethesda, MD
compliance. These procedures may has been approved under OMB control 20852, 301–796–5733, PRAStaff@
include, but are not limited to, review numbers 0910–0308 and 0910–0458; fda.hhs.gov.
of records and manufacturing deviations parts 601 and 660 have been approved SUPPLEMENTARY INFORMATION: In
and defects, and periodic audits. under OMB control number 0910–0338; compliance with 44 U.S.C. 3507, FDA
For shared manufacturing part 803 has been approved under OMB has submitted the following proposed
arrangements, each manufacturer must control number 0910–0437; part 211 has collection of information to OMB for
submit a separate biologics license been approved under OMB control review and clearance.
application describing the number 0910–0139; part 820 has been
manufacturing facilities and operations approved under OMB control number Prescription Drug Advertisements (OMB
mstockstill on DSK30JT082PROD with NOTICES
applicable to the preparation of that 0910–0073; parts 207, 607, and 807 have Control Number 0910–0686—Extension)
manufacturer’s biological substance or been approved under OMB control This information collection supports
product (§ 601.2(a)). In the guidance, we numbers 0910–0045, 0910–0052, and Agency regulations. Section 502(n) of
state that we expect the manufacturer 0910–0625; and parts 201, 801, and 809 the Federal Food, Drug, and Cosmetic
that prepares, or is responsible for the have been approved under OMB control Act (the FD&C Act) (21 U.S.C. 352(n))
preparation of, the product in final form numbers 0910–0537, 0910–0572, and requires that manufacturers, packers,
for commercial distribution to assume 0910–0485. and distributors (sponsors) who
VerDate Sep<11>2014 18:14 Aug 04, 2017 Jkt 241001 PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 E:\FR\FM\07AUN1.SGM 07AUN1](https://thefederalregister.org/doc/82_FR_36947/page/3.svg)
Document Created: 2017-08-05 03:00:01
Document Modified: 2017-08-05 03:00:01
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Submit either electronic or written comments on the collection of information by October 6, 2017. | |
| Contact | Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3850, [email protected] | |
| FR Citation | 82 FR 36797 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR