80 FR 63802 - Manufacturing Site Change Supplements: Content and Submission; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 203 (October 21, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 203 (October 21, 2015)
| Page Range | 63802-63804 | |
| FR Document | 2015-26637 |
[Federal Register Volume 80, Number 203 (Wednesday, October 21, 2015)] [Notices] [Pages 63802-63804] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-26637] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-3454] Manufacturing Site Change Supplements: Content and Submission; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Manufacturing Site Change Supplements: Content and Submission''. This draft guidance describes the decision-making steps that FDA recommends to determine whether a premarket approval application (PMA) supplement should be submitted when a manufacturer intends to change the manufacturing site (including a change to the processing, packaging, or sterilization site) of its legally marketed PMA-approved device. This guidance also discusses the general factors FDA intends to consider to determine whether a preapproval inspection is necessary before approval of the PMA supplement. This draft guidance is not final nor is it in effect at this time. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment of this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by January 19, 2016. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://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): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, 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-2015-N-3454 for ``Manufacturing Site Change Supplements: Content and Submission.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. [[Page 63803]] 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 Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. An electronic copy of the guidance document is available for download from the Internet. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written requests for a single hard copy of the draft guidance document entitled ``Manufacturing Site Change Supplements: Content and Submission'' to the Office of the Center Director, Guidance and Policy Development, Center for Devices and Radiological Health (CDRH), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002; or to the Office of Communication, Outreach, and Development, Center for Biologics Evaluation and Research (CBER), 10903 New Hampshire Ave., Bldg. 71, Rm. 3103, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 301-847-8149. FOR FURTHER INFORMATION CONTACT: William MacFarland, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Silver Spring, MD 20993-0002, 301-796-5547; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240-402-7911. SUPPLEMENTARY INFORMATION: I. Background Under section 515(d)(6) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360e(d)(6)), a PMA supplement must be submitted for review and approval by FDA before making a change that affects the device's safety or effectiveness, unless such change is a modification in a manufacturing procedure or method of manufacture, which would be eligible for a 30-day notice. The PMA regulations provide general criteria in Sec. 814. 39 (21 CFR 814.39) for determining when PMA holders are required to submit a PMA supplement or are eligible to submit a 30-day notice. Pursuant to Sec. 814.39(a)(3), a PMA holder must submit a PMA supplement for review and approval by FDA concerning the ``use of a different facility or establishment to manufacture, process, or package the device'' that affects the safety or effectiveness of a device before implementing the change. With respect to establishment inspections, section 510(h) of the FD&C Act (21 U.S.C. 360(h)) requires every registered establishment to be subject to inspections pursuant to section 704 of the FD&C Act (21 U.S.C. 374) and to be inspected at least once in the 2-year period after registration and at least once in every successive 2-year period thereafter. In March 1996, CDRH sent a letter to the medical device industry that announced a 1-year pilot program to improve the processing of PMA supplements for changes in manufacturing sites. The letter discussed the need to improve the speed and efficiency of CDRH review and approval of manufacturing site change supplements, and stated that CDRH did not require preapproval inspection for all site changes. CDRH later developed the draft guidance entitled ``Likelihood of Facilities Inspections When Modifying Devices Subject to Premarket Approval,'' which was issued on August 5, 1999. This guidance was never finalized. The PMA supplements described in the March 1996 letter and the 1999 draft guidance were called ``site change supplements'' or, if no preapproval inspection was required, they were termed ``express supplements.'' FDA now identifies all such submissions as ``site change supplements'' with a designation of whether or not an inspection is needed before the change can be implemented. Based on feedback from industry and the Agency's experience over many years, FDA has made substantial revisions and updates to the 1999 draft guidance and is reissuing it for comment as this Level 1 draft guidance. This guidance document explains: (1) What constitutes a manufacturing site change and when a manufacturer should submit a PMA supplement for a site change; (2) what documentation a manufacturer should submit in the site change supplement; and (3) the general factors that FDA intends to consider when determining whether to conduct an establishment inspection prior to approval of a site change supplement. This guidance is intended to help industry decide when a change in manufacturing site should be submitted in a PMA site change supplement. The guidance is also intended to help industry predict when a preapproval inspection in connection with a PMA supplement for a manufacturing site change will likely be needed to evaluate the firm's implementation of Quality System regulation requirements, 21 CFR part 820. As a result, this guidance should help manufacturers manage the timeframes associated with implementing the changes in the manufacturing site and any processes, methods, procedures, qualifications, and validations. Please note that this guidance only applies to a manufacturer of a device with an approved PMA, a product development protocol, or a humanitarian device exemption. This guidance does not address manufacturing site changes for devices cleared under premarket notification (510(k)) submissions. II. Significance of 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 manufacturing site change supplements' content and submission. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative [[Page 63804]] approach if it satisfies the requirements of the applicable statutes and regulations. III. Electronic Access Persons interested in obtaining a copy of the draft guidance may do so by downloading an electronic copy from the Internet. A search capability for all CDRH guidance documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at http://www.regulations.gov or from CBER at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. Persons unable to download an electronic copy of ``Manufacturing Site Change Supplements: Content and Submission'' may send an email request to [email protected] to receive an electronic copy of the document. Please use the document number 1269 to identify the guidance you are requesting. IV. Paperwork Reduction Act of 1995 This draft guidance 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 814, subparts B and E have been approved under OMB control number 0910-0231; the collections of information in 21 CFR part 814, subpart H have been approved under OMB control number 0910-0332; and the collections of information in 21 CFR part 820 have been approved under OMB control number 0910-0073. Dated: October 15, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-26637 Filed 10-20-15; 8:45 am] BILLING CODE 4164-01-P
![63802 Federal Register / Vol. 80, No. 203 / Wednesday, October 21, 2015 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Average
Number of
Number of Total annual burden per Total annual
Type of respondent Activity responses per
respondents responses response hours
respondent (in hours)
LGBT young adults aged Screener—First media
18–24 in the select media tracking. 556 1 556 0.083 46
markets—Recruited via Screener—Second media
social media (30% com- tracking. 556 1 556 0.083 46
bined eligibility and re- Screener—Third media
sponse rate). tracking. 556 1 556 0.083 46
Media tracking screeners .... ............................................. 1,668 ........................ 1,668 ........................ 138
LGBT young adults aged Questionnaire—First media
18–24 in the select media tracking. 167 167 0.667 111
markets—Recruited via Questionnaire—Second
social media (30% com- media tracking. 167 1 167 0.667 111
bined eligibility and re- Questionnaire—Third media
sponse rate). tracking. 167 1 167 0.667 111
Media tracking question- ............................................. 501 ........................ 501 ........................ 333
naires.
Total media tracking ............................................. 2,169 ........................ 2,169 ........................ 471
(screeners and ques-
tionnaires).
Totals Across All ............................................. 15,288 ........................ 15,288 ........................ 3,839
Study Compo-
nents.
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 15, 2015. intends to consider to determine identifies you in the body of your
Leslie Kux, whether a preapproval inspection is comments, that information will be
Associate Commissioner for Policy. necessary before approval of the PMA posted on http://www.regulations.gov.
[FR Doc. 2015–26671 Filed 10–20–15; 8:45 am] supplement. This draft guidance is not • If you want to submit a comment
BILLING CODE 4164–01–P final nor is it in effect at this time. with confidential information that you
DATES: Although you can comment on do not wish to be made available to the
any guidance at any time (see 21 CFR public, submit the comment as a
DEPARTMENT OF HEALTH AND 10.115(g)(5)), to ensure that the Agency written/paper submission and in the
HUMAN SERVICES considers your comment of this draft manner detailed (see ‘‘Written/Paper
guidance before it begins work on the Submissions’’ and ‘‘Instructions’’).
Food and Drug Administration final version of the guidance, submit Written/Paper Submissions
[Docket No. FDA–2015–N–3454] either electronic or written comments
Submit written/paper submissions as
on the draft guidance by January 19,
Manufacturing Site Change follows:
2016. • Mail/Hand delivery/Courier (for
Supplements: Content and ADDRESSES: You may submit comments written/paper submissions): Division of
Submission; Draft Guidance for as follows: Dockets Management (HFA–305), Food
Industry and Food and Drug
Electronic Submissions and Drug Administration, 5630 Fishers
Administration Staff; Availability
Lane, Rm. 1061, Rockville, MD 20852.
AGENCY: Food and Drug Administration, Submit electronic comments in the • For written/paper comments
HHS. following way: submitted to the Division of Dockets
ACTION: Notice. • Federal eRulemaking Portal: http:// Management, FDA will post your
www.regulations.gov. Follow the comment, as well as any attachments,
SUMMARY: The Food and Drug instructions for submitting comments. except for information submitted,
Administration (FDA) is announcing the Comments submitted electronically, marked and identified, as confidential,
availability of the draft guidance including attachments, to http:// if submitted as detailed in
entitled ‘‘Manufacturing Site Change www.regulations.gov will be posted to ‘‘Instructions.’’
Supplements: Content and the docket unchanged. Because your Instructions: All submissions received
Submission’’. This draft guidance comment will be made public, you are must include the Docket No. FDA–
describes the decision-making steps that solely responsible for ensuring that your 2015–N–3454 for ‘‘Manufacturing Site
FDA recommends to determine whether comment does not include any Change Supplements: Content and
a premarket approval application (PMA) confidential information that you or a Submission.’’ Received comments will
tkelley on DSK3SPTVN1PROD with NOTICES
supplement should be submitted when third party may not wish to be posted, be placed in the docket and, except for
a manufacturer intends to change the such as medical information, your or those submitted as ‘‘Confidential
manufacturing site (including a change anyone else’s Social Security number, or Submissions,’’ publicly viewable at
to the processing, packaging, or confidential business information, such http://www.regulations.gov or at the
sterilization site) of its legally marketed as a manufacturing process. Please note Division of Dockets Management
PMA-approved device. This guidance that if you include your name, contact between 9 a.m. and 4 p.m., Monday
also discusses the general factors FDA information, or other information that through Friday.
VerDate Sep<11>2014 22:39 Oct 20, 2015 Jkt 238001 PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 E:\FR\FM\21OCN1.SGM 21OCN1](https://thefederalregister.org/doc/80_FR_64005/page/1.svg)
![63804 Federal Register / Vol. 80, No. 203 / Wednesday, October 21, 2015 / Notices
approach if it satisfies the requirements ACTION: Notice. information, including each proposed
of the applicable statutes and extension of an existing collection of
regulations. SUMMARY: The Food and Drug information, and to allow 60 days for
Administration (FDA) is announcing public comment in response to the
III. Electronic Access that a collection of information entitled notice. This notice solicits comments on
Persons interested in obtaining a copy ‘‘Administrative Practices and information collection associated with
of the draft guidance may do so by Procedures; Formal Evidentiary Public the processes available to outside
downloading an electronic copy from Hearing’’ has been approved by the stakeholders to request additional
the Internet. A search capability for all Office of Management and Budget review of decisions or actions by Center
CDRH guidance documents is available (OMB) under the Paperwork Reduction for Devices and Radiological Health
at http://www.fda.gov/MedicalDevices/ Act of 1995. (CDRH) employees.
DeviceRegulationandGuidance/ FOR FURTHER INFORMATION CONTACT: FDA DATES: Submit either electronic or
GuidanceDocuments/default.htm. PRA Staff, Office of Operations, Food written comments on the collection of
Guidance documents are also available and Drug Administration, 8455 information by December 21, 2015.
at http://www.regulations.gov or from Colesville Rd., COLE–14526, Silver
ADDRESSES: You may submit comments
CBER at http://www.fda.gov/Biologics Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov. as follows:
BloodVaccines/GuidanceCompliance
RegulatoryInformation/default.htm. SUPPLEMENTARY INFORMATION: On May Electronic Submissions
Persons unable to download an 12, 2015, the Agency submitted a Submit electronic comments in the
electronic copy of ‘‘Manufacturing Site proposed collection of information following way:
Change Supplements: Content and entitled ‘‘Administrative Practices and • Federal eRulemaking Portal: http://
Submission’’ may send an email request Procedures; Formal Evidentiary Public www.regulations.gov. Follow the
to CDRH-Guidance@fda.hhs.gov to Hearing’’ to OMB for review and instructions for submitting comments.
receive an electronic copy of the clearance under 44 U.S.C. 3507. An Comments submitted electronically,
document. Please use the document Agency may not conduct or sponsor, including attachments, to http://
number 1269 to identify the guidance and a person is not required to respond www.regulations.gov will be posted to
you are requesting. to, a collection of information unless it the docket unchanged. Because your
IV. Paperwork Reduction Act of 1995 displays a currently valid OMB control comment will be made public, you are
number. OMB has now approved the solely responsible for ensuring that your
This draft guidance refers to information collection and has assigned comment does not include any
previously approved collections of OMB control number 0910–0191. The confidential information that you or a
information found in FDA regulations. approval expires on September 30, third party may not wish to be posted,
These collections of information are 2018. A copy of the supporting such as medical information, your or
subject to review by the Office of statement for this information collection anyone else’s Social Security number, or
Management and Budget (OMB) under is available on the Internet at http:// confidential business information, such
the Paperwork Reduction Act of 1995 www.reginfo.gov/public/do/PRAMain. as a manufacturing process. Please note
(44 U.S.C. 3501–3520). The collections
Dated: October 15, 2015. that if you include your name, contact
of information in 21 CFR part 814,
Leslie Kux, information, or other information that
subparts B and E have been approved
Associate Commissioner for Policy.
identifies you in the body of your
under OMB control number 0910–0231;
comments, that information will be
the collections of information in 21 CFR [FR Doc. 2015–26639 Filed 10–20–15; 8:45 am]
posted on http://www.regulations.gov.
part 814, subpart H have been approved BILLING CODE 4164–01–P
• If you want to submit a comment
under OMB control number 0910–0332;
with confidential information that you
and the collections of information in 21
DEPARTMENT OF HEALTH AND do not wish to be made available to the
CFR part 820 have been approved under
HUMAN SERVICES public, submit the comment as a
OMB control number 0910–0073.
written/paper submission and in the
Dated: October 15, 2015. manner detailed (see ‘‘Written/Paper
Food and Drug Administration
Leslie Kux, Submissions’’ and ‘‘Instructions’’).
Associate Commissioner for Policy. [Docket No. FDA–2011–D–0893]
Written/Paper Submissions
[FR Doc. 2015–26637 Filed 10–20–15; 8:45 am]
Agency Information Collection Submit written/paper submissions as
BILLING CODE 4164–01–P Activities; Proposed Collection; follows:
Comment Request; Center for Devices • Mail/Hand delivery/Courier (for
and Radiological Health Appeals written/paper submissions): Division of
DEPARTMENT OF HEALTH AND Processes
HUMAN SERVICES Dockets Management (HFA–305), Food
AGENCY: Food and Drug Administration, and Drug Administration, 5630 Fishers
Food and Drug Administration HHS. Lane, rm. 1061, Rockville, MD 20852.
ACTION: Notice. • For written/paper comments
[Docket No. FDA–2014–N–2029] submitted to the Division of Dockets
Agency Information Collection SUMMARY: The Food and Drug Management, FDA will post your
Activities; Announcement of Office of Administration (FDA) is announcing an comment, as well as any attachments,
tkelley on DSK3SPTVN1PROD with NOTICES
Management and Budget Approval; opportunity for public comment on the except for information submitted,
Administrative Practices and proposed collection of certain marked and identified, as confidential,
Procedures; Formal Evidentiary Public information by the Agency. Under the if submitted as detailed in
Hearing Paperwork Reduction Act of 1995 (the ‘‘Instructions.’’
PRA), Federal Agencies are required to Instructions: All submissions received
AGENCY: Food and Drug Administration, publish notice in the Federal Register must include the Docket No. [FDA–
HHS. concerning each proposed collection of 2011–D–0893] for Agency Information
VerDate Sep<11>2014 22:39 Oct 20, 2015 Jkt 238001 PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 E:\FR\FM\21OCN1.SGM 21OCN1](https://thefederalregister.org/doc/80_FR_64005/page/3.svg)
Document Created: 2018-02-27 08:53:54
Document Modified: 2018-02-27 08:53:54
| 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 | Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment of this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by January 19, 2016. | |
| Contact | William MacFarland, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Silver Spring, MD 20993-0002, 301-796-5547; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240-402-7911. | |
| FR Citation | 80 FR 63802 |
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