80 FR 63232 - Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Detention and Banned Medical Devices
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 201 (October 19, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 201 (October 19, 2015)
| Page Range | 63232-63234 | |
| FR Document | 2015-26440 |
[Federal Register Volume 80, Number 201 (Monday, October 19, 2015)] [Notices] [Pages 63232-63234] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-26440] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0306] Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Detention and Banned Medical Devices 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 [[Page 63233]] public comment in response to the notice. This notice solicits comments on information collection for administrative detention and banned medical devices. DATES: Submit either electronic or written comments on the collection of information by December 18, 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-2012-N-0306 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Detention and Banned Medical Devices.'' 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. Administrative Detention and Banned Medical Devices--21 CFR 800.55(g)(1) and (g)(2), 800.55(k), 895.21(d), and 895.22 OMB Control Number 0910-0114--Extension FDA has the statutory authority under section 304(g) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 334(g)) to detain during established inspections devices that are believed to be adulterated or misbranded. Section 800.55 (21 CFR 800.55), on administrative detention, includes among other things, certain reporting requirements and recordkeeping requirements. Under Sec. 800.55(g), an applicant of a detention order must show documentation of ownership if devices are detained at a place other than that of the appellant. Under Sec. 800.55(k), the owner or other responsible person must supply records about how the devices may have become adulterated or misbranded, in addition to records of distribution of the detained devices. These recordkeeping requirements for administrative detentions permit FDA to trace devices for which the detention period expired before a seizure is accomplished or injunctive relief is obtained. FDA also has the statutory authority under section 516 of the FD&C Act (21 [[Page 63234]] U.S.C. 360f) to ban devices that present substantial deception or an unreasonable and substantial risk of illness or injury. Section 895.21 (21 CFR 895.21), on banned devices, contains certain reporting requirements. Section 895.21(d) describes the procedures for banning a device when the Commissioner of Food and Drugs (the Commissioner) decides to initiate such a proceeding. Under 21 CFR 895.22, a manufacturer, distributor, or importer of a device may be required to submit to FDA all relevant and available data and information to enable the Commissioner to determine whether the device presents substantial deception, unreasonable and substantial risk of illness or injury, or unreasonable, direct, and substantial danger to the health of individuals. During the past several years, there has been an average of less than one new administrative detention action per year. Each administrative detention will have varying amounts of data and information that must be maintained. FDA's estimate of the burden under the administrative detention provision is based on FDA's discussion with one of the firms whose devices had been detained. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Average 21 CFR section Number of responses per Total annual burden per Total hours respondents respondent responses response ---------------------------------------------------------------------------------------------------------------- 800.55(g)....................... 1 1 1 25 25 895.21(d)(8) and 895.22(a)...... 26 1 26 16 416 ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 441 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Table 2--Estimated Annual Recordkeeping Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Average burden 21 CFR section Number of records per Total annual per Total hours recordkeepers recordkeeper records recordkeeping -------------------------------------------------------------------------------------------------------------------------------------------------------- 800.55(k).......................................................... 1 1 1 20 20 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: October 13, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-26440 Filed 10-16-15; 8:45 am] BILLING CODE 4164-01-P
![63232 Federal Register / Vol. 80, No. 201 / Monday, October 19, 2015 / Notices
• If you want to submit a comment applicable disclosure law. For more II. Significance of Guidance
with confidential information that you information about FDA’s posting of This level 1 guidance is being issued
do not wish to be made available to the comments to public dockets, see 80 FR consistent with FDA’s good guidance
public, submit the comment as a 56469, September 18, 2015, or access practices regulation (21 CFR 10.115).
written/paper submission and in the the information at: http://www.fda.gov/ The guidance represents the current
manner detailed (see ‘‘Written/Paper regulatoryinformation/dockets/ thinking of FDA on ‘‘Evaluating the
Submissions’’ and ‘‘Instructions’’). default.htm. Effectiveness of New Animal Drugs for
Written/Paper Submissions Docket: For access to the docket to the Reduction of Pathogenic Shiga
Submit written/paper submissions as read background documents or the Toxin-Producing E. coli in Cattle.’’ It
follows: electronic and written/paper comments does not establish any rights for any
• Mail/Hand delivery/Courier (for received, go to http:// person and is not binding on FDA or the
written/paper submissions): Division of www.regulations.gov and insert the public. You can use an alternative
Dockets Management (HFA–305), Food docket number, found in brackets in the approach if it satisfies the requirements
and Drug Administration, 5630 Fishers heading of this document, into the of applicable statutes and regulations.
Lane, Rm. 1061, Rockville, MD 20852. ‘‘Search’’ box and follow the prompts III. Paperwork Reduction Act of 1995
• For written/paper comments and/or go to the Division of Dockets
submitted to the Division of Dockets Management, 5630 Fishers Lane, Rm. This guidance refers to previously
Management, FDA will post your 1061, Rockville, MD 20852. approved collections of information
comment, as well as any attachments, found in FDA regulations. These
Submit written requests for single collections of information are subject to
except for information submitted,
copies of this guidance to the Policy and review by the Office of Management and
marked and identified, as confidential,
Regulations Staff (HFV–6), Center for Budget (OMB) under the Paperwork
if submitted as detailed in
Veterinary Medicine, Food and Drug Reduction Act of 1995 (44 U.S.C. 3501–
‘‘Instructions.’’
Instructions: All submissions received Administration, 7519 Standish Pl., 3520). The collections of information in
must include the Docket No. FDA– Rockville, MD 20855. Send one self- 21 CFR part 514 have been approved
2015–D–0235 for ‘‘Evaluating the addressed adhesive label to assist that under OMB control number 0910–0032.
Effectiveness of New Animal Drugs for office in processing your request. See
the SUPPLEMENTARY INFORMATION section IV. Electronic Access
the Reduction of Pathogenic Shiga
Toxin-Producing E. coli in Cattle; for electronic access to the guidance Persons with access to the Internet
Guidance for Industry; Availability.’’ document. may obtain the draft guidance at either
Received comments will be placed in http://www.fda.gov/AnimalVeterinary/
FOR FURTHER INFORMATION CONTACT:
the docket and, except for those GuidanceComplianceEnforcement/
Joshua R. Hayes, Center for Veterinary GuidanceforIndustry/default.htm or
submitted as ‘‘Confidential
Medicine (HFV–133), Food and Drug http://www.regulations.gov.
Submissions,’’ publicly viewable at
Administration, 7500 Standish Pl.,
http://www.regulations.gov or at the Dated: October 13, 2015.
Rockville, MD 20855, 240–402–0585,
Division of Dockets Management Leslie Kux,
joshua.hayes@fda.hhs.gov.
between 9 a.m. and 4 p.m., Monday Associate Commissioner for Policy.
through Friday. SUPPLEMENTARY INFORMATION:
[FR Doc. 2015–26438 Filed 10–16–15; 8:45 am]
• Confidential Submissions—To
submit a comment with confidential I. Background BILLING CODE 4164–01–P
information that you do not wish to be In the Federal Register of February
made publicly available, submit your 24, 2015 (80 FR 9731), FDA published DEPARTMENT OF HEALTH AND
comments only as a written/paper
a notice of availability for a draft HUMAN SERVICES
submission. You should submit two
guidance entitled ‘‘Evaluating the
copies total. One copy will include the Food and Drug Administration
Effectiveness of New Animal Drugs for
information you claim to be confidential
the Reduction of Pathogenic Shiga [Docket No. FDA–2012–N–0306]
with a heading or cover note that states
Toxin-Producing E. coli in Cattle’’
‘‘THIS DOCUMENT CONTAINS
giving interested persons until April 27, Agency Information Collection
CONFIDENTIAL INFORMATION’’. The
2015, to comment on the draft guidance. Activities; Proposed Collection;
Agency will review this copy, including
FDA received one comment on the draft Comment Request; Administrative
the claimed confidential information, in
guidance. An editorial change to Detention and Banned Medical Devices
its consideration of comments. The
improve clarity was made in finalizing
second copy, which will have the AGENCY: Food and Drug Administration,
claimed confidential information this guidance document. The guidance
HHS.
redacted/blacked out, will be available announced in this notice finalizes the
guidance dated February 2015. ACTION: Notice.
for public viewing and posted on
http://www.regulations.gov. Submit The guidance discusses general SUMMARY: The Food and Drug
both copies to the Division of Dockets considerations regarding the Administration (FDA) is announcing an
Management. If you do not wish your development of protocols, study opportunity for public comment on the
name and contact information to be conduct, animal welfare, substantial proposed collection of certain
asabaliauskas on DSK5VPTVN1PROD with NOTICES
made publicly available, you can evidence of effectiveness, experimental information by the Agency. Under the
provide this information on the cover parameters, nutritional content of Paperwork Reduction Act of 1995 (the
sheet and not in the body of your experimental diets, and the assessment PRA), Federal Agencies are required to
comments and you must identify this of drug concentrations in experimental publish notice in the Federal Register
information as ‘‘confidential.’’ Any diets. It also discusses the studies and concerning each proposed collection of
information marked as ‘‘confidential’’ analyses CVM recommends for sponsors information, including each proposed
will not be disclosed except in to substantiate the effectiveness of extension of an existing collection of
accordance with 21 CFR 10.20 and other pathogenic STEC reduction drugs. information, and to allow 60 days for
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![63234 Federal Register / Vol. 80, No. 201 / Monday, October 19, 2015 / Notices
U.S.C. 360f) to ban devices that present a device may be required to submit to year. Each administrative detention will
substantial deception or an FDA all relevant and available data and have varying amounts of data and
unreasonable and substantial risk of information to enable the Commissioner information that must be maintained.
illness or injury. Section 895.21 (21 CFR to determine whether the device FDA’s estimate of the burden under the
895.21), on banned devices, contains presents substantial deception, administrative detention provision is
certain reporting requirements. Section unreasonable and substantial risk of based on FDA’s discussion with one of
895.21(d) describes the procedures for illness or injury, or unreasonable, direct, the firms whose devices had been
banning a device when the and substantial danger to the health of detained.
Commissioner of Food and Drugs (the individuals.
Commissioner) decides to initiate such During the past several years, there FDA estimates the burden of this
a proceeding. Under 21 CFR 895.22, a has been an average of less than one collection of information as follows:
manufacturer, distributor, or importer of new administrative detention action per
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
21 CFR section responses per burden per Total hours
respondents responses
respondent response
800.55(g) .............................................................................. 1 1 1 25 25
895.21(d)(8) and 895.22(a) .................................................. 26 1 26 16 416
Total .............................................................................. ........................ ........................ ........................ ........................ 441
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Average
Number of Total annual
21 CFR section records per burden per Total hours
recordkeepers records
recordkeeper recordkeeping
800.55(k) .............................................................................. 1 1 1 20 20
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 13, 2015. Georgia Ave., Suite 400, Silver Spring, DEPARTMENT OF HEALTH AND
Leslie Kux, MD 20910–3492. HUMAN SERVICES
Associate Commissioner for Policy.
FOR FURTHER INFORMATION CONTACT: Health Resources and Services
[FR Doc. 2015–26440 Filed 10–16–15; 8:45 am]
Deborah Kallgren, Office of Women’s Administration
BILLING CODE 4164–01–P
Health, Food and Drug Administration,
10903 New Hampshire Ave., Silver Advisory Commission on Childhood
DEPARTMENT OF HEALTH AND Spring, MD 20993–0002, 301–796–9440, Vaccines; Request for Nominations for
HUMAN SERVICES FAX: 301–847–8604, deborah.kallgren@ Voting Members
fda.hhs.gov.
AGENCY: Health Resources and Services
Food and Drug Administration SUPPLEMENTARY INFORMATION: There is Administration, HHS.
[Docket No. FDA–2015–N–0001] no fee, but pre-registration is required. ACTION: Notice.
Send registration information (including
Office of Women’s Health Update on name, title, organization name, address, SUMMARY: The Health Resources and
Strategic Priorities and Initiatives for telephone, and fax number) to Deborah Services Administration (HRSA) is
Nurses Kallgren. Seating is limited to 35 requesting nominations to fill six
AGENCY: Food and Drug Administration, participants (1 person per organization). vacancies on the Advisory Commission
HHS. on Childhood Vaccines (ACCV). The
If you need special accommodations ACCV was established by Title XXI of
ACTION: Notice of meeting. due to a disability, please contact the Public Health Service Act (the Act),
Deborah Kallgren (see FOR FURTHER as enacted by Public Law (Pub. L.) 99–
SUMMARY: The Food and Drug
INFORMATION CONTACT) at least 7 days in 660 and as subsequently amended, and
Administration (FDA) is announcing the
following meeting: Office of Women’s advance. advises the Secretary of Health and
Health Update on Strategic Priorities Dated: October 13, 2015. Human Services (the Secretary) on
and Initiatives. FDA staff will provide Leslie Kux, issues related to implementation of the
updates on strategic priorities, National Vaccine Injury Compensation
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Associate Commissioner for Policy.
educational outreach, and research Program (VICP).
[FR Doc. 2015–26433 Filed 10–16–15; 8:45 am]
initiatives of interest to national DATES: The agency will receive
BILLING CODE 4164–01–P
organizations for nursing professionals nominations on or before December 18,
and students. 2015.
DATES: The meeting will be held on ADDRESSES: All nominations are to be
November 18, 2015, 1 p.m. to 3 p.m. submitted to the Director, Division of
ADDRESSES: The meeting will be held at Injury Compensation Programs,
the American Nurses Association, 8515 Healthcare Systems Bureau (HSB),
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Document Created: 2015-12-15 08:35:58
Document Modified: 2015-12-15 08:35:58
| 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 18, 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 63232 |
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