82 FR 60750 - Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 245 (December 22, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 245 (December 22, 2017)
| Page Range | 60750-60752 | |
| FR Document | 2017-27589 |
[Federal Register Volume 82, Number 245 (Friday, December 22, 2017)] [Notices] [Pages 60750-60752] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-27589] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-1995-D-0288 (Formerly Docket No. 95D-0052)] Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled ``Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products; Draft Guidance for Industry.'' The draft guidance is intended to assist applicants and manufacturers of certain licensed biological products in determining which reporting category is appropriate for a change in chemistry, manufacturing, and controls (CMC) information to an approved biologics license application (BLA). The draft guidance provides applicants and manufacturers general and administrative information on reporting and evaluating changes and recommendations for reporting categories based on a tiered-reporting system for specific changes. The draft guidance, when finalized, is intended to supersede the document entitled ``Guidance for Industry: Changes to an Approved Application: Biological Products'' dated July 1997 (July 1997 guidance). DATES: Submit either electronic or written comments on the draft guidance by March 22, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time as follows: 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 [[Page 60751]] 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-1995-D-0288 (formerly Docket No. 95D-0052) for ``Chemistry, Manufacturing, and Controls Changes to an Approved Application: Biological Products.'' Received comments 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 http://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. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of the draft guidance to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993- 0002. Send one self-addressed adhesive label to assist the office in processing your requests. The draft guidance may also be obtained by mail by calling CBER at 1-800-835-4709 or 240-402-8010. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Jessica T. Walker, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft document entitled ``Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products; Draft Guidance for Industry.'' The draft guidance, when finalized, is intended to assist applicants and manufacturers of licensed biological products in determining which reporting category is appropriate for a change in CMC to an approved BLA as specified in 21 CFR 601.12. The draft guidance provides applicants and manufacturers general and administrative information on reporting and evaluating changes and recommendations for reporting categories based on a tiered-reporting system for specific changes under Sec. 601.12. FDA issued the July 1997 guidance (62 FR 39904; July 24, 1997) to assist applicants in determining which reporting mechanism is appropriate for reporting a change to an approved application to reduce the burden on manufacturers when reporting changes and to facilitate the approval process of the change being made. We are updating the July 1997 guidance to accommodate advances in manufacturing and testing technology and to clarify the FDA's current thinking on assessing reportable changes. The updated guidance applies to certain biological products licensed under the Public Health Service Act (PHS Act), including in vitro diagnostics licensed under BLAs. This draft guidance applies to all manufacturing locations, including contract locations. The following biological products are not within the scope of this guidance: Whole blood, blood components, source plasma, and source leukocytes. This draft guidance also does not apply to human cells, tissues, and cellular and tissue-based products regulated solely under section 361 of the PHS Act (42 U.S.C. 264), as described in 21 CFR part 1271; specified biotechnology and specified synthetic biological products; and biosimilar biological products subject to licensure under section 351(k) of the PHS Act. The draft guidance, when finalized, is intended to supersede the July 1997 guidance. This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on ``Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products.'' It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866. II. Paperwork Reduction Act of 1995 This draft guidance also refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501- 3520). The collections of information in 21 CFR part 210 and [[Page 60752]] 21 CFR part 211 have been approved under OMB control number 0910-0139; the collections of information in 21 CFR 601.12 have been approved under OMB control numbers 0910-0338, and the collections of information in 21 CFR part 820 have been approved under OMB control number 0910- 0073. III. Electronic Access Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov. Dated: December 19, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-27589 Filed 12-21-17; 8:45 am] BILLING CODE 4164-01-P
![60750 Federal Register / Vol. 82, No. 245 / Friday, December 22, 2017 / Notices
organizations, disease advocacy of the Patient Engagement Collaborative DEPARTMENT OF HEALTH AND
organizations, voluntary health Framework is available at https:// HUMAN SERVICES
agencies, nonprofit research www.ctti-clinicaltrials.org/framework-
foundations, and public health cttifda-patient-engagement- Food and Drug Administration
organizations. The ultimate goal of the collaborative. [Docket No. FDA–1995–D–0288 (Formerly
nomination and selection process is to Docket No. 95D–0052)]
identify individuals who can represent IV. Nomination Process
a collective patient voice for their Chemistry, Manufacturing, and
Any interested person may nominate
patient community. Controls Changes to an Approved
Selection criteria include the one or more qualified individuals for
membership on the PEC. Self- Application: Certain Biological
nominee’s potential to meaningfully Products; Draft Guidance for Industry;
contribute to the activities of the PEC, nominations are also accepted.
Availability
ability to represent and express the Nominations should include the
patient voice for his or her constituency, following: (1) A personal statement AGENCY: Food and Drug Administration,
ability to work in a constructive manner (maximum 800 words) from the HHS.
with involved stakeholders, and nominee explaining his or her interest ACTION: Notice of availability.
understanding of the clinical research in becoming a member of the PEC; (2)
enterprise. Consideration will also be a current, complete curriculum vitae or SUMMARY: The Food and Drug
given to ensuring the PEC includes resume that shows relevant activities Administration (FDA or Agency) is
diverse perspectives and experiences, announcing the availability of a draft
and experience; and (3) an optional
including but not limited to, document entitled ‘‘Chemistry,
letter of endorsement (maximum 800
sociodemographic and disease Manufacturing, and Controls Changes to
words) from a patient group with which an Approved Application: Certain
experience diversity. It is anticipated
that approximately half of the PEC the nominee has worked closely on Biological Products; Draft Guidance for
membership will be selected from activities relevant to the PEC. Industry.’’ The draft guidance is
eligible CTTI member organizations and The personal statement and optional intended to assist applicants and
individuals, and half will be selected letter of endorsement (if provided) manufacturers of certain licensed
from other nominees. Members are should emphasize information relevant biological products in determining
required to be citizens and residents of to the criteria for membership described which reporting category is appropriate
the United States. above. The letter may address topics for a change in chemistry,
Financial and other conflicts of such as the nominee’s involvement in manufacturing, and controls (CMC)
interest will not necessarily make patient advocacy activities, experiences information to an approved biologics
nominees ineligible for membership in that stimulated an interest in license application (BLA). The draft
the PEC. However, nominees cannot be participating in discussions about guidance provides applicants and
direct employees of the medical product manufacturers general and
patient engagement in medical product
development industry. administrative information on reporting
development and regulatory decision-
III. Responsibilities and Expectations making, and other information that may and evaluating changes and
be helpful in evaluating the nominee’s recommendations for reporting
Meetings of the PEC will typically be categories based on a tiered-reporting
held four times per year, either in- qualifications as a potential member of
system for specific changes. The draft
person (in the Washington, DC area) or the PEC.
guidance, when finalized, is intended to
by webinar, and additional meetings Nominations must provide the supersede the document entitled
may be organized as needed. nominee’s contact information (phone ‘‘Guidance for Industry: Changes to an
Accommodations will be made for and email preferred), as well as state Approved Application: Biological
members with special needs for travel or that the nominee is aware of the Products’’ dated July 1997 (July 1997
for participation in a meeting (e.g., nomination (unless self-nominated) and guidance).
accommodations for physical mobility is willing to serve as a member of the
impairments, dietary restrictions, etc.). DATES: Submit either electronic or
PEC. written comments on the draft guidance
Nominations for PEC membership are
encouraged for individuals of all racial, Additional information may be by March 22, 2018 to ensure that the
ethnic, sexual orientation, and cultural needed from nominees, including Agency considers your comment on this
groups with and without disabilities. information relevant to understanding draft guidance before it begins work on
Travel support will be provided. potential sources of conflict of interest, the final version of the guidance.
To help ensure continuity in its in which case nominees will be ADDRESSES: You may submit comments
activities and organizational knowledge, contacted directly. on any guidance at any time as follows:
the PEC will maintain staggered Dated: December 15, 2017. Electronic Submissions
membership terms for patient
Leslie Kux, Submit electronic comments in the
community representatives.
Membership terms are anticipated as 1- Associate Commissioner for Policy. following way:
to 2-year appointments, and will be [FR Doc. 2017–27538 Filed 12–20–17; 8:45 am] • Federal eRulemaking Portal:
determined during the process of BILLING CODE 4164–01–P https://www.regulations.gov. Follow the
instructions for submitting comments.
sradovich on DSK3GMQ082PROD with NOTICES
selecting members. Members may serve
up to two terms, with the possibility of Comments submitted electronically,
extensions. including attachments, to https://
Additional responsibilities and www.regulations.gov will be posted to
expectations are set forth in the Patient the docket unchanged. Because your
Engagement Collaborative Framework, comment will be made public, you are
which should be reviewed prior to solely responsible for ensuring that your
submitting a nomination. The full text comment does not include any
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21 CFR part 211 have been approved FOR FURTHER INFORMATION CONTACT: show that one-on-one mentoring
under OMB control number 0910–0139; Sherrette Funn, Sherrette.Funn@hhs.gov through healthy eating, physical
the collections of information in 21 CFR or (202) 795–7714. When submitting activity, and sport participation can
601.12 have been approved under OMB comments or requesting information, support the development of social skills,
control numbers 0910–0338, and the please include the document identifier improve positive self-esteem, and
collections of information in 21 CFR 0990–New–30D and project title for increase self-confidence among children
part 820 have been approved under reference. and adults with a disability. I Can Do It,
OMB control number 0910–0073. SUPPLEMENTARY INFORMATION: Interested You Can Do It! partners with K–12
III. Electronic Access persons are invited to send comments schools and school districts, colleges
regarding this burden estimate or any and universities, and other community-
Persons with access to the internet other aspect of this collection of based entities to provide access and
may obtain the draft guidance at either information, including any of the opportunities for children and adults
https://www.fda.gov/BiologicsBlood following subjects: (1) The necessity and with a wide range of physical and
Vaccines/GuidanceCompliance utility of the proposed information cognitive disabilities to lead healthy,
RegulatoryInformation/Guidances/ collection for the proper performance of active lives. PCFSN plans to conduct a
default.htm or https:// the agency’s functions; (2) the accuracy rigorous evaluation of I Can Do It, You
www.regulations.gov. of the estimated burden; (3) ways to Can Do It! The evaluation will assess the
Dated: December 19, 2017. enhance the quality, utility, and clarity impact of the program on mentee level
Leslie Kux, of the information to be collected; and outcomes (impact evaluation) as well as
Associate Commissioner for Policy. (4) the use of automated collection barriers and facilitators to program
[FR Doc. 2017–27589 Filed 12–21–17; 8:45 am]
techniques or other forms of information implementation (process evaluation).
technology to minimize the information Evaluation activities will take place in
BILLING CODE 4164–01–P
collection burden. 10 sites between summer 2018 and fall
Title of the Collection: I Can Do It, 2019. The I Can Do It, You Can Do It!
DEPARTMENT OF HEALTH AND You Can Do It! Program Evaluation. sites recruited to participate in the
Type of Collection: New.
HUMAN SERVICES OMB No. 0990—NEW—Office within evaluation will be identified from a list
OS—President’s Council on Fitness, of schools and community organizations
[Document Identifier: OS–0990–new]
Sports & Nutrition (PCFSN), Office of that have signed up to be program sites.
Agency Information Collection the Assistant Secretary for Health. The aims of the process evaluation are
Request. 30-Day Public Comment Abstract: Approximately 56 million to determine what parts of the program
Request children and adults living in the United were successful, the usefulness of
States have some level of disability. program materials, and what changes
AGENCY: Office of the Secretary, HHS. Despite physical activity and good are necessary to improve the
ACTION: Notice. nutrition being the cornerstones of administration of the program. The aims
evidence-based health promotion of the impact evaluation are to examine
SUMMARY: In compliance with the interventions for reducing the risk of how ICDI impacts Mentee physical
requirement of the Paperwork comorbidities (e.g., diabetes, heart activity and healthy eating behaviors.
Reduction Act of 1995, the Office of the disease, and stroke), many people with The information collected for the I Can
Secretary (OS), Department of Health a disability or caregivers who have a Do It, You Can Do It! Program
and Human Services, is publishing the child with a disability experience Evaluation will allow the OPCFSN and
following summary of a proposed substantial difficulty accessing these partners to assess the impact of the
collection for public comment. programs. Benefits of physical activity program and gather critical information
DATES: Comments on the ICR must be and good nutrition have been well for improvement. OMB approval is
received on or before January 22, 2018. documented for individuals with and requested for three years. Participation
ADDRESSES: Submit your comments to without a disability, including: reducing in I Can Do It, You Can Do It! is
OIRA_submission@omb.eop.gov or via the risk of developing chronic diseases voluntary and there are no costs to
facsimile to (202) 395–5806. and medical conditions. Studies also respondents other than their time.
ESTIMATED ANNUALIZED BURDEN TABLE
Number of Average
Number of Total burden
Forms Respondents responses per burden per
respondents hours
respondents response
Site Application ................................. Site Coordinator ............................... 10 1 7/60 1
Partner Application ............................ National Partner Organizations ........ 50 1 15/60 12
Site Annual Follow-Up Survey .......... Site Coordinator ............................... 10 1 5/60 1
End of Wave 1 Interview .................. Site Coordinator ............................... 10 1 30/60 5
End of Wave 1 Feedback Survey ..... Site Coordinator ............................... 10 1 11/60 2
End of Wave 2 Interview .................. Site Coordinator ............................... 10 1 30/60 5
End of Wave 2 Feedback Survey ..... Site Coordinator ............................... 10 1 6/60 1
sradovich on DSK3GMQ082PROD with NOTICES
Technical Assistance Assessment ... Site Coordinator ............................... 10 1 10/60 2
Mentee Pre-Assessment ................... Mentee/Program Participant ............ 700 1 20/60 233
Mentee Post-Assessment ................. Mentee/Program Participant ............ 700 1 25/60 292
Mentor Feedback Survey .................. Mentor .............................................. 700 1 8/60 94
Weekly Goal-Setting Guide .............. Mentor .............................................. 700 8 10/60 936
Total ........................................... ........................................................... ........................ 19 ........................ 1,584
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Document Created: 2017-12-22 00:33:52
Document Modified: 2017-12-22 00:33:52
| 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 of availability. | |
| Dates | Submit either electronic or written comments on the draft guidance by March 22, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. | |
| Contact | Jessica T. Walker, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911. | |
| FR Citation | 82 FR 60750 |
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