81 FR 24820 - Agency Information Collection Activities; Proposed Collection; Comment Request; Requests for Clinical Laboratory Improvement Amendments Categorization
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 81 (April 27, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 81 (April 27, 2016)
| Page Range | 24820-24822 | |
| FR Document | 2016-09769 |
[Federal Register Volume 81, Number 81 (Wednesday, April 27, 2016)] [Notices] [Pages 24820-24822] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-09769] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0514] Agency Information Collection Activities; Proposed Collection; Comment Request; Requests for Clinical Laboratory Improvement Amendments Categorization 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 requests for Clinical Laboratory Improvement Amendments of 1998 (CLIA) categorization of in vitro diagnostic tests when a premarket review is not needed. DATES: Submit either electronic or written comments on the collection of information by June 27, 2016. [[Page 24821]] 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-2013-N-0514 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; Requests for Clinical Laboratory Improvement Amendments Categorization.'' 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, [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. Requests for Clinical Laboratory Improvement Amendments of 1988 Categorization--42 CFR 493.17--OMB Control Number 0910-0607--Extension A guidance document entitled ``Guidance for Administrative Procedures for CLIA Categorization'' was released on May 7, 2008. The document describes procedures FDA uses to assign the complexity category to a device. Typically, FDA assigns complexity categorizations to devices at the time of clearance or approval of the device. In this way, no additional burden is incurred by the manufacturer because the labeling (including operating instructions) is included in the premarket notification (510(k)) or premarket approval application (PMA). In some cases, however, a manufacturer may request CLIA categorization even if FDA is not simultaneously reviewing a 510(k) or PMA. One example is when a manufacturer requests that FDA assign CLIA categorization to a previously cleared device that has changed names since the original CLIA categorization. Another example is when a device is exempt from premarket review. In such cases, the guidance recommends that manufacturers provide FDA with a copy of the package insert for the device and a cover letter indicating why the manufacturer is requesting a categorization (e.g. name change, exempt from 510(k) review). The guidance recommends that in the correspondence to FDA the manufacturer should identify the product code and classification as well as reference to the original 510(k) when this is available. [[Page 24822]] FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Total operating Number of Number of Total annual Average burden and Activity respondents responses per responses per response Total hours maintenance respondent costs -------------------------------------------------------------------------------------------------------------------------------------------------------- Request for CLIA Categorization................... 60 15 900 1 900 $46,800 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs associated with this collection of information. The number of respondents is approximately 60. On average, each respondent will request categorizations (independent of a 510(k) or PMA) 15 times per year. The cost, not including personnel, is estimated at $52 per hour (52 x 900), totaling $46,800. This includes the cost of copying and mailing copies of package inserts and a cover letter, which includes a statement of the reason for the request and reference to the original 510(k) numbers, including regulation numbers and product codes. The burden hours are based on FDA familiarity with the types of documentation typically included in a sponsor's categorization requests, and costs for basic office supplies (e.g., paper). Dated: April 21, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-09769 Filed 4-26-16; 8:45 am] BILLING CODE 4164-01-P
![24820 Federal Register / Vol. 81, No. 81 / Wednesday, April 27, 2016 / Notices
answer the following questions as much and how do they affect your daily life? FDA will hold an open public
as possible from the patient’s (Examples of downsides may include comment period to give the public an
perspective. bothersome side effects, need for opportunity to comment. Registration
multiple medications, risk of infection, for open public comment will occur at
Topic 1: Disease Symptoms and Daily
need for hospitalization, etc.) the registration desk on the day of the
Impacts That Matter Most to Patients (a) What are the biggest challenges meeting and workshop on a first-come,
1. What have been the most you face in maintaining your post- first-served basis.
significant changes in your overall transplant treatment regimen? Docket Comments: Regardless of if
health since you received your (Examples of challenges may be you attend the public meeting, you can
transplanted organ? bothersome side effects, need for submit electronic or written responses
(a) How long has it been since you multiple medications, etc.) to the questions pertaining to Topics 1
received your transplant? 4. What specific things would you and 2 to the public docket (see
2. Focusing on symptoms related to look for in an ideal treatment for ADDRESSES) by November 27, 2016.
your organ transplant and post- managing your transplanted organ? Received comments may be seen in the
transplant effects, which 1–3 symptoms In the afternoon, discussion will be Division of Dockets Management
have the most significant impact on related to scientific topics, with the goal between 9 a.m. and 4 p.m., Monday
your life? (Examples may include pain, of understanding issues that may affect through Friday, and will be posted to
infection, anxiety, etc.) the development of drugs for the the docket at http://
3. Are there specific activities that are treatment of organ transplantation and www.regulations.gov.
important to you but that you cannot do identifying topics for future discussion. Transcripts: As soon as a transcript is
at all or as fully as you would like Discussion topics for the afternoon will available, FDA will post it at http://
because of your transplant? (Examples include the following: Current treatment www.fda.gov/ForIndustry/UserFees/
of activities may include sleeping considerations, adherence, clinical trial PrescriptionDrugUserFee/
through the night, driving, walking/ designs, and clinical trial endpoints. ucm495933.htm.
running, exercising, etc.) B. Meeting Attendance and Dated: April 21, 2016.
(a) How do your symptoms and their Participation Leslie Kux,
negative impacts affect your daily life Associate Commissioner for Policy.
on the best days? On the worst days? If you wish to attend this meeting,
visit http:// [FR Doc. 2016–09785 Filed 4–26–16; 8:45 am]
(Examples may include limitations on
the ability to undertake physically organtransplantpfdd.eventbrite.com. BILLING CODE 4164–01–P
strenuous activities, restrictions on the Please register by September 20, 2016. If
ability to travel, lack of appetite, fatigue, you are unable to attend the meeting in
person, you can register to view a live DEPARTMENT OF HEALTH AND
etc.) HUMAN SERVICES
4. How has your experience with your Webcast of the meeting. You will be
transplanted organ changed over time? asked to indicate in your registration if
you plan to attend in person or via the Food and Drug Administration
Do particular symptoms come and go as
your duration of time with a Webcast. Seating will be limited, so [Docket No. FDA–2013–N–0514]
transplanted organ has increased? If so, early registration is recommended.
Registration is free and will be on a first- Agency Information Collection
do you know of anything that makes Activities; Proposed Collection;
your symptoms better? Worse? come, first-served basis. However, FDA
may limit the number of participants Comment Request; Requests for
5. What worries you most about your
from each organization based on space Clinical Laboratory Improvement
health post-transplant?
limitations. Registrants will receive Amendments Categorization
Topic 2: Patients’ Perspectives on confirmation once they have been AGENCY: Food and Drug Administration,
Transplant and Treatment Impacts accepted. Onsite registration on the day HHS.
1. What are you currently doing to of the meeting will be based on space ACTION: Notice.
maintain your transplanted organ or availability. If you need special
treat related health concerns following accommodations because of a disability, SUMMARY: The Food and Drug
transplantation? (Examples may include please contact Graham Thompson (see Administration (FDA) is announcing an
immunosuppressants, antibiotics, FOR FURTHER INFORMATION CONTACT) at opportunity for public comment on the
antivirals, over-the-counter products, least 7 days before the meeting. proposed collection of certain
and other therapies including non-drug Patients who are interested in information by the Agency. Under the
therapies) presenting comments as part of the Paperwork Reduction Act of 1995 (the
(a) How has your post-transplant initial panel discussions will be asked PRA), Federal Agencies are required to
treatment regimen changed over time, to indicate in their registration which publish notice in the Federal Register
and why? topic(s) they wish to address. These concerning each proposed collection of
2. How well does your current patients also must send to information, including each proposed
treatment regimen manage the most PatientFocused@fda.hhs.gov a brief extension of an existing collection of
significant symptoms you experience summary of responses to the topic information, and to allow 60 days for
post-transplantation? questions by September 12, 2016. public comment in response to the
(a) How well do these treatments Panelists will be notified of their notice. This notice solicits comments on
asabaliauskas on DSK3SPTVN1PROD with NOTICES
improve your ability to do specific selection approximately 7 days before requests for Clinical Laboratory
activities that are important to you in the public meeting. We will try to Improvement Amendments of 1998
your daily life? accommodate all patients and patient (CLIA) categorization of in vitro
(b) How well have these treatments stakeholders who wish to speak, either diagnostic tests when a premarket
worked for you as your experiences through the panel discussion or review is not needed.
post-transplant have changed over time? audience participation; however, the DATES: Submit either electronic or
3. What are the most significant duration of comments may be limited by written comments on the collection of
downsides to your current treatments, time constraints. information by June 27, 2016.
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![24822 Federal Register / Vol. 81, No. 81 / Wednesday, April 27, 2016 / Notices
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Total operating
Number of Average
Number of Total annual and
Activity responses per burden per Total hours
respondents responses maintenance
respondent response costs
Request for CLIA Categorization ............. 60 15 900 1 900 $46,800
1 There are no capital costs associated with this collection of information.
The number of respondents is Administration, 10903 New Hampshire Dated: April 19, 2016.
approximately 60. On average, each Avenue, Silver Spring, MD 20993, 301– Sylvia M. Burwell,
respondent will request categorizations 796–3291. Secretary of Health and Human Services.
(independent of a 510(k) or PMA) 15 [FR Doc. 2016–09761 Filed 4–26–16; 8:45 am]
I. Summary
times per year. The cost, not including BILLING CODE P
personnel, is estimated at $52 per hour This organization will expand current
(52 × 900), totaling $46,800. This activities in the Office of Medical Policy
includes the cost of copying and mailing and foster efficient oversight of clinical DEPARTMENT OF HEALTH AND
copies of package inserts and a cover trials conducted through policy HUMAN SERVICES
letter, which includes a statement of the initiatives that build quality upfront and
reason for the request and reference to science-based inspectional approaches. Health Resources and Services
the original 510(k) numbers, including This will provide an oversight and Administration
regulation numbers and product codes. direction for new and ongoing policy
The burden hours are based on FDA initiatives in broad-based medical and Agency Information Collection
familiarity with the types of clinical policy areas, including Activities: Proposed Collection: Public
documentation typically included in a initiatives to improve science and Comment Request
sponsor’s categorization requests, and efficiency trials.
The Food and Drug Administration, AGENCY: Health Resources and Services
costs for basic office supplies (e.g.,
Office of Medical Products and Tobacco, Administration, HHS.
paper).
Center for Drug Evaluation and ACTION: Notice.
Dated: April 21, 2016.
Research, Office of Medical Policy has
Leslie Kux, been restructured as follows: SUMMARY: In compliance with the
Associate Commissioner for Policy. DKKNF. ORGANIZATION. The Office requirement for opportunity for public
[FR Doc. 2016–09769 Filed 4–26–16; 8:45 am] of Medical Policy is headed by the comment on proposed data collection
BILLING CODE 4164–01–P Director, Office of Medical Policy and projects (Section 3506(c)(2)(A) of the
includes the following organizational Paperwork Reduction Act of 1995), the
units: Health Resources and Services
DEPARTMENT OF HEALTH AND Office of Medical Policy Administration (HRSA) announces
HUMAN SERVICES Office of Prescription Drug Promotion plans to submit an Information
Division of Advertising and Promotion Collection Request (ICR), described
Food and Drug Administration Review I below, to the Office of Management and
Division of Advertising and Promotion Budget (OMB). Prior to submitting the
Office of Medical Products and
Review II ICR to OMB, HRSA seeks comments
Tobacco; Center for Drug Evaluation
II. Delegations of Authority from the public regarding the burden
and Research; Statement of
estimate, below, or any other aspect of
Organization, Functions, and Pending further delegation, directives, the ICR.
Delegations of Authority or orders by the Commissioner of Food
DATES: Comments on this Information
AGENCY: Food and Drug Administration, and Drugs, all delegations and
Collection Request must be received no
HHS. redelegations of authority made to
later than June 27, 2016.
ACTION: Notice. officials and employees of affected
organizational components will ADDRESSES: Submit your comments to
SUMMARY: The Food and Drug continue in them or their successors paperwork@hrsa.gov or mail the HRSA
Administration (FDA), Office of Medical pending further redelegations, provided Information Collection Clearance
Products and Tobacco, Center for Drug they are consistent with this Officer, Room 14N39, Parklawn
Evaluation and Research, Office of reorganization. Building, 5600 Fishers Lane, Rockville,
Medical Policy has modified its MD 20857.
III. Electronic Access FOR FURTHER INFORMATION CONTACT: To
structure. This new organizational
structure was approved by the Secretary This reorganization is reflected in request more information on the
asabaliauskas on DSK3SPTVN1PROD with NOTICES
of Health and Human Services on FDA’s Staff Manual Guides (SMG). proposed project or to obtain a copy of
December 15, 2016, and effective on Persons interested in seeing the the data collection plans and draft
April 17, 2016. complete Staff Manual Guide can find it instruments, email paperwork@hrsa.gov
FOR FURTHER INFORMATION CONTACT: on FDA’s Web site at: http:// or call the HRSA Information Collection
Melanie Keller, Office of Management, www.fda.gov/AboutFDA/ Clearance Officer at (301) 443–1984.
Center for Drug Evaluation and ReportsManualsForms/ SUPPLEMENTARY INFORMATION: When
Research, Office of Medical Products StaffManualGuides/default.htm. submitting comments or requesting
and Tobacco, Food and Drug Authority: 44 U.S.C. 3101. information, please include the
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Document Created: 2018-02-07 13:55:52
Document Modified: 2018-02-07 13:55:52
| 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. | |
| Dates | Submit either electronic or written comments on the collection of information by June 27, 2016. | |
| 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 | 81 FR 24820 |
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