83 FR 16865 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; 513(g) Request for Information
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 74 (April 17, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 74 (April 17, 2018)
| Page Range | 16865-16866 | |
| FR Document | 2018-07980 |
[Federal Register Volume 83, Number 74 (Tuesday, April 17, 2018)] [Notices] [Pages 16865-16866] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-07980] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-N-0913] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; 513(g) Request for Information AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by May 17, 2018. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202-395-7285, or emailed to [email protected]. All comments should be identified with the OMB control number 0910-0705. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, [email protected]. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. 513(g) Request for Information OMB Control Number 0910-0705--Extension This information collection supports Agency regulations and accompanying guidance. Section 513(g) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(g)) provides a means for obtaining the Agency's views about the classification and regulatory requirements that may be applicable to a particular device. Section 513(g) provides that, within 60 days of the receipt of a written request of any person for information respecting the class in which a device has been classified or the requirements applicable to a device under the FD&C Act, the Secretary of Health and Human Services shall provide such person a written statement of the classification (if any) of such device and the requirements of the FD&C Act applicable to the device. Regulations governing medical device classification procedures are codified under 21 CFR part 860. The guidance document entitled ``FDA and Industry Procedures for Section 513(g) Requests for Information Under the Federal Food, Drug, and Cosmetic Act; Guidance for Industry and Food and Drug Administration Staff'' establishes procedures for submitting, reviewing, and responding to requests for information respecting the class in which a device has been classified or the requirements applicable to a device under the FD&C Act that are submitted in accordance with section 513(g) of the FD&C Act. FDA does not review data related to substantial equivalence or safety and effectiveness in a 513(g) request for information. FDA's responses to 513(g) requests for information are not device classification decisions and do not constitute FDA clearance or approval for marketing. Classification decisions and clearance or approval for marketing require submissions under different sections of the FD&C Act. [[Page 16866]] Relatedly, the FD&C Act, as amended by the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85), requires FDA to collect user fees for 513(g) requests for information. The guidance document entitled ``Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g) Requests for Information'' assists FDA staff and regulated industry by describing the user fees associated with 513(g) requests. The Medical Device User Fee Cover Sheet (Form FDA 3601), which accompanies the supplemental material described in this information collection is approved under OMB control number 0910-0511. In the Federal Register of November 21, 2017 (82 FR 55381) FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received in response to the notice. We therefore retain the currently approved burden estimate for the information collection, which is as follows: 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 513(g) requests............ 114 1 114 12 1,368 CBER 513(g) requests............ 4 1 4 12 48 ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 1,416 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs of operating and maintenance costs associated with this collection off information. Respondents to the collection of information are mostly device manufacturers; however, anyone may submit a 513(g) request for information. The total number of annual responses is based on the average number of 513(g) requests received each year by the Agency. Dated: April 12, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-07980 Filed 4-16-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 74 / Tuesday, April 17, 2018 / Notices 16865
online screener will be asked to provide hours. Added to the original 6,000 hours—an estimated increase of 4,813
their parents’ or guardians’ contact parents and 100 burden hours, the total hours from the last approval.
information to provide parental consent number of parental online screeners and In the Federal Register of December
for the main survey. The process of consents will be 6,700 and the total 26, 2017 (82 FR 61003), FDA published
parents and guardians providing burden will be 111 hours. a 60-day notice requesting public
consent for eligible youth will take comment on the proposed collection of
With these additions, the estimated
approximately 1 minute. For the fourth information. One comment was
number of voluntary respondents/
and fifth post-test surveys, we estimate received; however, this comment was
that an additional 700 adults will be responses for all waves of data not PRA related.
contacted to provide consent for eligible collection for the study is 107,743, and FDA estimates the burden of this
youth for a total of 11 additional burden the total burden is estimated at 15,135 collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
Number of Total annual Average burden per
Type of respondent/activity responses per Total hours
respondents responses response
respondent
Youth Mail screener-outcome survey ...................... 23,685 1 23,685 0.0833 (5 minutes) .... 1,973
Cross-Sectional Youth Refresher Sample, Post-test 4,920 1 4,920 0.75 (45 minutes) ...... 3,690
and assent/consent process-outcome surveys 1–
5.
Youth Pre-test and assent/consent process-out- 2,194 1 2,194 0.50 (30 minutes) ...... 1,097
come survey.
Longitudinal Youth Cohort, Post-test and assent/ 6,039 1 6,039 0.75 (45 minutes) ...... 4,530
consent process-outcome surveys 1–5.
Youth Online screener-outcome survey .................. 40,000 1 40,000 0.0833 (5 minutes) .... 3,332
Adult parental permission process-outcome survey 30,905 1 30,905 0.0166 (1 minute) ...... 513
Total .................................................................. 107,743 ........................ ........................ .................................... 15,135
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: April 12, 2018. Information and Regulatory Affairs, of any person for information respecting
Leslie Kux, OMB, Attn: FDA Desk Officer, Fax: 202– the class in which a device has been
Associate Commissioner for Policy. 395–7285, or emailed to oira_ classified or the requirements applicable
[FR Doc. 2018–07971 Filed 4–16–18; 8:45 am] submission@omb.eop.gov. All to a device under the FD&C Act, the
BILLING CODE 4164–01–P
comments should be identified with the Secretary of Health and Human Services
OMB control number 0910–0705. Also shall provide such person a written
include the FDA docket number found statement of the classification (if any) of
DEPARTMENT OF HEALTH AND in brackets in the heading of this such device and the requirements of the
HUMAN SERVICES document. FD&C Act applicable to the device.
FOR FURTHER INFORMATION CONTACT: Regulations governing medical device
Food and Drug Administration Amber Sanford, Office of Operations, classification procedures are codified
[Docket No. FDA–2014–N–0913] Food and Drug Administration, Three under 21 CFR part 860.
White Flint North, 10A–12M, 11601 The guidance document entitled
Agency Information Collection Landsdown St., North Bethesda, MD ‘‘FDA and Industry Procedures for
Activities; Submission for Office of 20852, 301–796–8867, PRAStaff@ Section 513(g) Requests for Information
Management and Budget Review; fda.hhs.gov. Under the Federal Food, Drug, and
Comment Request; 513(g) Request for Cosmetic Act; Guidance for Industry
Information SUPPLEMENTARY INFORMATION: In and Food and Drug Administration
compliance with 44 U.S.C. 3507, FDA Staff’’ establishes procedures for
AGENCY: Food and Drug Administration, has submitted the following proposed submitting, reviewing, and responding
HHS. collection of information to OMB for to requests for information respecting
ACTION: Notice. review and clearance. the class in which a device has been
513(g) Request for Information classified or the requirements applicable
SUMMARY: The Food and Drug
to a device under the FD&C Act that are
Administration (FDA) is announcing OMB Control Number 0910–0705— submitted in accordance with section
that a proposed collection of Extension 513(g) of the FD&C Act. FDA does not
information has been submitted to the
This information collection supports review data related to substantial
Office of Management and Budget
Agency regulations and accompanying equivalence or safety and effectiveness
(OMB) for review and clearance under
guidance. Section 513(g) of the Federal in a 513(g) request for information.
the Paperwork Reduction Act of 1995.
Food, Drug, and Cosmetic Act (the FDA’s responses to 513(g) requests for
daltland on DSKBBV9HB2PROD with NOTICES
DATES: Fax written comments on the FD&C Act) (21 U.S.C. 360c(g)) provides information are not device classification
collection of information by May 17, a means for obtaining the Agency’s decisions and do not constitute FDA
2018. views about the classification and clearance or approval for marketing.
ADDRESSES: To ensure that comments on regulatory requirements that may be Classification decisions and clearance or
the information collection are received, applicable to a particular device. approval for marketing require
OMB recommends that written Section 513(g) provides that, within 60 submissions under different sections of
comments be faxed to the Office of days of the receipt of a written request the FD&C Act.
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![16866 Federal Register / Vol. 83, No. 74 / Tuesday, April 17, 2018 / Notices
Relatedly, the FD&C Act, as amended FDA staff and regulated industry by a 60-day notice requesting public
by the Food and Drug Administration describing the user fees associated with comment on the proposed collection of
Amendments Act of 2007 (Pub. L. 110– 513(g) requests. The Medical Device information. No comments were
85), requires FDA to collect user fees for User Fee Cover Sheet (Form FDA 3601), received in response to the notice.
513(g) requests for information. The which accompanies the supplemental
We therefore retain the currently
guidance document entitled ‘‘Guidance material described in this information
approved burden estimate for the
for Industry and Food and Drug collection is approved under OMB
control number 0910–0511. information collection, which is as
Administration Staff; User Fees for follows:
In the Federal Register of November
513(g) Requests for Information’’ assists
21, 2017 (82 FR 55381) FDA published
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 513(g) requests ........................................................ 114 1 114 12 1,368
CBER 513(g) requests ......................................................... 4 1 4 12 48
Total .............................................................................. ........................ ........................ ........................ ........................ 1,416
1 There are no capital costs of operating and maintenance costs associated with this collection off information.
Respondents to the collection of ADDRESSES: You may submit either • For written/paper comments
information are mostly device electronic or written comments on submitted to the Dockets Management
manufacturers; however, anyone may Agency guidances at any time as Staff, FDA will post your comment, as
submit a 513(g) request for information. follows: well as any attachments, except for
The total number of annual responses is information submitted, marked and
Electronic Submissions identified, as confidential, if submitted
based on the average number of 513(g)
requests received each year by the Submit electronic comments in the as detailed in ‘‘Instructions.’’
Agency. following way: Instructions: All submissions received
• Federal eRulemaking Portal: must include the Docket No. FDA–
Dated: April 12, 2018.
https://www.regulations.gov. Follow the 2009–D–0524 for ‘‘Listing of Ingredients
Leslie Kux,
instructions for submitting comments. in Tobacco Products.’’ Received
Associate Commissioner for Policy. comments will be placed in the docket
[FR Doc. 2018–07980 Filed 4–16–18; 8:45 am]
Comments submitted electronically,
including attachments, to https:// and, except for those submitted as
BILLING CODE 4164–01–P
www.regulations.gov will be posted to ‘‘Confidential Submissions,’’ publicly
the docket unchanged. Because your viewable at https://www.regulations.gov
comment will be made public, you are or at the Dockets Management Staff
DEPARTMENT OF HEALTH AND between 9 a.m. and 4 p.m., Monday
HUMAN SERVICES solely responsible for ensuring that your
comment does not include any through Friday.
• Confidential Submissions—To
Food and Drug Administration confidential information that you or a
submit a comment with confidential
third party may not wish to be posted,
information that you do not wish to be
such as medical information, your or
[Docket No. FDA–2009–D–0524] made publicly available, submit your
anyone else’s Social Security number, or
comments only as a written/paper
Listing of Ingredients in Tobacco confidential business information, such
submission. You should submit two
Products; Guidance for Industry; as a manufacturing process. Please note copies total. One copy will include the
Availability that if you include your name, contact information you claim to be confidential
information, or other information that with a heading or cover note that states
AGENCY: Food and Drug Administration, identifies you in the body of your
HHS. ‘‘THIS DOCUMENT CONTAINS
comments, that information will be CONFIDENTIAL INFORMATION.’’ The
ACTION: Notice of availability. posted on https://www.regulations.gov. Agency will review this copy, including
• If you want to submit a comment the claimed confidential information, in
SUMMARY: The Food and Drug with confidential information that you its consideration of comments. The
Administration (FDA or we) is do not wish to be made available to the second copy, which will have the
announcing the availability of a revised public, submit the comment as a claimed confidential information
final guidance for industry entitled written/paper submission and in the redacted/blacked out, will be available
‘‘Listing of Ingredients in Tobacco manner detailed (see ‘‘Written/Paper for public viewing and posted on
Products.’’ The revised guidance Submissions’’ and ‘‘Instructions’’). https://www.regulations.gov. Submit
document is intended to assist persons
Written/Paper Submissions both copies to the Dockets Management
making tobacco product ingredient
Staff. If you do not wish your name and
daltland on DSKBBV9HB2PROD with NOTICES
submissions to FDA as required by the Submit written/paper submissions as contact information to be made publicly
Family Smoking Prevention and follows: available, you can provide this
Tobacco Control Act (Tobacco Control • Mail/Hand delivery/Courier (for information on the cover sheet and not
Act). written/paper submissions): Dockets in the body of your comments and you
DATES: The announcement of the Management Staff (HFA–305), Food and must identify this information as
guidance is published in the Federal Drug Administration, 5630 Fishers ‘‘confidential.’’ Any information marked
Register on April 17, 2018. Lane, Rm. 1061, Rockville, MD 20852. as ‘‘confidential’’ will not be disclosed
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Document Created: 2018-04-17 02:52:29
Document Modified: 2018-04-17 02:52:29
| 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 | Fax written comments on the collection of information by May 17, 2018. | |
| Contact | Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, [email protected] | |
| FR Citation | 83 FR 16865 |
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