80 FR 63804 - Agency Information Collection Activities; Proposed Collection; Comment Request; Center for Devices and Radiological Health Appeals Processes
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 | 63804-63806 | |
| FR Document | 2015-26672 |
[Federal Register Volume 80, Number 203 (Wednesday, October 21, 2015)] [Notices] [Pages 63804-63806] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-26672] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0893] Agency Information Collection Activities; Proposed Collection; Comment Request; Center for Devices and Radiological Health Appeals Processes AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the 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 information collection associated with the processes available to outside stakeholders to request additional review of decisions or actions by Center for Devices and Radiological Health (CDRH) employees. DATES: Submit either electronic or written comments on the collection of information by December 21, 2015. 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-2011-D-0893] for Agency Information [[Page 63805]] Collection Activities; Proposed Collection; Comment Request; Center for Devices and Radiological Health Appeals Processes. 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. 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. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, PRAStaff@fda.hhs.gov. 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. Center for Devices and Radiological Health Appeals Processes--OMB Control Number 0910-0738--Extension The guidance document entitled ``Guidance for Industry and Food and Drug Administration Staff; Center for Devices and Radiological Health Appeals Processes'' describes the processes available to outside stakeholders to request additional review of decisions or actions by CDRH employees. FDA is seeking approval for the new reporting burden associated with requests for additional review of decisions and actions by CDRH employees as described in the guidance. Individuals outside of FDA who disagree with a decision or action taken by CDRH and wish to have it reviewed or reconsidered have several processes for resolution from which to choose, including: Requests for supervisory review of an action; petitions; and hearings. Of these, by far the most commonly used is a request for supervisory review under 21 CFR 10.75 (a ``10.75 appeal''). Section 517A of the FD&C Act, added by section 603 of the FDA Safety and Innovation Act of 2012, includes new requirements pertaining to the process and timelines for 10.75 appeals of ``significant decisions'' regarding 510(k) premarket notifications, applications for premarket approvals (PMAs), and applications for investigational device exemptions (IDEs). A request for review under section 10.75 should be based on the information that was already present in the administrative file at the time of the decision that is being reviewed as provided in 21 CFR 10.75(d). New section 517A of the FD&C Act refers to significant decisions regarding the information in the administrative file for premarket notifications (section 510(k)); PMAs (section 515); and IDEs (section 520(g)) submissions is collected under existing regulations which specify the information manufacturers must submit so that FDA may properly evaluate the safety and effectiveness of medical devices. The information collections associated with these regulations are currently approved by the Office of Management and Budget as follows: The collections of information in 21 CFR part 807, subpart E (premarket notification) have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 814 (premarket approval) have been approved under OMB control number 0910-0231; and the collections of information in 21 CFR part 812 (investigational device exemption) have been approved under OMB control number 0910-0078. While CDRH already possesses in the administrative file the information that would form the basis of a decision on a matter under appeal, the submission of particular information regarding the request itself and the data and information relied on by the requestor in the appeal would facilitate timely resolution of the decision under review. The guidance describes the collection of information not expressly specified under existing regulations: The submission of the request for review, minor clarifications as part of the request, and supporting information. FDA estimates the burden of this collection of information as follows: [[Page 63806]] Table 1--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Activity Number of responses per Total annual Average burden Total hours respondents respondent responses per response -------------------------------------------------------------------------------------------------------------------------------------------------------- CDRH Appeals Processes Guidance Document........................... 50 1 50 8 400 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: October 15, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-26672 Filed 10-20-15; 8:45 am] BILLING CODE 4164-01-P
![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_64007/page/1.svg)
![63806 Federal Register / Vol. 80, No. 203 / Wednesday, October 21, 2015 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Activity responses per burden per Total hours
respondents responses
respondent response
CDRH Appeals Processes Guidance Document ................ 50 1 50 8 400
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 15, 2015. confidential information that you or a CONFIDENTIAL INFORMATION’’. The
Leslie Kux, third party may not wish to be posted, Agency will review this copy, including
Associate Commissioner for Policy. such as medical information, your or the claimed confidential information, in
[FR Doc. 2015–26672 Filed 10–20–15; 8:45 am] anyone else’s Social Security number, or its consideration of comments. The
BILLING CODE 4164–01–P
confidential business information, such second copy, which will have the
as a manufacturing process. Please note claimed confidential information
that if you include your name, contact redacted/blacked out, will be available
DEPARTMENT OF HEALTH AND information, or other information that for public viewing and posted on
HUMAN SERVICES identifies you in the body of your http://www.regulations.gov. Submit
comments, that information will be both copies to the Division of Dockets
Food and Drug Administration posted on http://www.regulations.gov. Management. If you do not wish your
[Docket No. FDA–2012–N–0427]
• If you want to submit a comment name and contact information to be
with confidential information that you made publicly available, you can
Agency Information Collection do not wish to be made available to the provide this information on the cover
Activities; Proposed Collection; public, submit the comment as a sheet and not in the body of your
Comment Request; Medical Devices; written/paper submission and in the comments and you must identify this
Inspection by Accredited Persons manner detailed (see ‘‘Written/Paper information as ‘‘confidential.’’ Any
Program Submissions’’ and ‘‘Instructions’’). information marked as ‘‘confidential’’
will not be disclosed except in
AGENCY: Food and Drug Administration, Written/Paper Submissions
accordance with 21 CFR 10.20 and other
HHS. Submit written/paper submissions as applicable disclosure law. For more
ACTION: Notice. follows: information about FDA’s posting of
• Mail/Hand delivery/Courier (for comments to public dockets, see 80 FR
SUMMARY: The Food and Drug written/paper submissions): Division of 56469, September 18, 2015, or access
Administration (FDA) is announcing an Dockets Management (HFA–305), Food the information at: http://www.fda.gov/
opportunity for public comment on the and Drug Administration, 5630 Fishers regulatoryinformation/dockets/
proposed collection of certain Lane, Rm. 1061, Rockville, MD 20852. default.htm.
information by the Agency. Under the • For written/paper comments Docket: For access to the docket to
Paperwork Reduction Act of 1995 (the submitted to the Division of Dockets read background documents or the
PRA), Federal Agencies are required to Management, FDA will post your electronic and written/paper comments
publish notice in the Federal Register comment, as well as any attachments, received, go to http://
concerning each proposed collection of except for information submitted, www.regulations.gov and insert the
information, including each proposed marked and identified, as confidential, docket number, found in brackets in the
extension of an existing collection of if submitted as detailed in heading of this document, into the
information, and to allow 60 days for ‘‘Instructions’’. ‘‘Search’’ box and follow the prompts
public comment in response to the Instructions: All submissions received and/or go to the Division of Dockets
notice. This notice solicits comments on must include the Docket No.FDA–2012– Management, 5630 Fishers Lane, Rm.
the Inspection by Accredited Persons N–0427 for ‘‘Agency Information 1061, Rockville, MD 20852.
Program Under the Medical Device User Collection Activities; Proposed
Fee and Modernization Act of 2002. FOR FURTHER INFORMATION CONTACT: FDA
Collection; Comment Request; Medical
PRA Staff, Office of Operations, Food
DATES: Submit either electronic or Devices; Inspection by Accredited
and Drug Administration, 8455
written comments on the collection of Persons Program’’. Received comments
Colesville Rd., COLE–14526, Silver
information by December 21, 2015. will be placed in the docket and, except
Spring, MD 20993–0002, PRAStaff@
ADDRESSES: You may submit comments for those submitted as ‘‘Confidential
fda.hhs.gov.
as follows: Submissions,’’ publicly viewable at
http://www.regulations.gov or at the SUPPLEMENTARY INFORMATION: Under the
Electronic Submissions Division of Dockets Management PRA (44 U.S.C. 3501–3520), Federal
Submit electronic comments in the between 9 a.m. and 4 p.m., Monday Agencies must obtain approval from the
following way: through Friday. Office of Management and Budget
• Federal eRulemaking Portal: http:// • Confidential Submissions—To (OMB) for each collection of
www.regulations.gov. Follow the submit a comment with confidential information they conduct or sponsor.
instructions for submitting comments. information that you do not wish to be ‘‘Collection of information’’ is defined
tkelley on DSK3SPTVN1PROD with NOTICES
Comments submitted electronically, made publicly available, submit your in 44 U.S.C. 3502(3) and 5 CFR
including attachments, to http:// comments only as a written/paper 1320.3(c) and includes Agency requests
www.regulations.gov will be posted to submission. You should submit two or requirements that members of the
the docket unchanged. Because your copies total. One copy will include the public submit reports, keep records, or
comment will be made public, you are information you claim to be confidential provide information to a third party.
solely responsible for ensuring that your with a heading or cover note that states Section 3506(c)(2)(A) of the PRA (44
comment does not include any ‘‘THIS DOCUMENT CONTAINS U.S.C. 3506(c)(2)(A)) requires Federal
VerDate Sep<11>2014 22:39 Oct 20, 2015 Jkt 238001 PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 E:\FR\FM\21OCN1.SGM 21OCN1](https://thefederalregister.org/doc/80_FR_64007/page/3.svg)
Document Created: 2018-02-27 08:53:51
Document Modified: 2018-02-27 08:53:51
| 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 December 21, 2015. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected] | |
| FR Citation | 80 FR 63804 |
2024 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR