83 FR 30736 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Administrative Practices and Procedures; Formal Evidentiary Public Hearing
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 126 (June 29, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 126 (June 29, 2018)
| Page Range | 30736-30738 | |
| FR Document | 2018-14058 |
[Federal Register Volume 83, Number 126 (Friday, June 29, 2018)] [Notices] [Pages 30736-30738] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-14058] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-N-2029] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Administrative Practices and Procedures; Formal Evidentiary Public Hearing 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 July 30, 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 0910-0191. 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. Administrative Practices and Procedures; Formal Evidentiary Public Hearing OMB Control Number 0910-0191--Extension The Administrative Procedures Act (5 U.S.C. 553(e)) provides that every Agency shall give an interested person the right to petition for issuance, amendment, or repeal of a rule. Section 10.30 (21 CFR 10.30) sets forth the format and procedures by which an interested person may submit to FDA, in accordance with Sec. 10.20 (21 CFR 10.20), a citizen petition requesting the Commissioner of Food and Drugs (the Commissioner) to issue, amend, or revoke a regulation or order, or to take or refrain from taking any other form of administrative action. The Commissioner may grant or deny such a petition, in whole or in part, and may grant such other relief or take other action as the petition warrants. Respondents are individuals or households, State or local governments, and not-for-profit institutions or groups. Section 10.33 (21 CFR 10.33), issued under section 701(a) of the Federal, Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 371(a)), sets forth the format and procedures by which an interested person may request reconsideration of part or all of a decision of the Commissioner on a petition submitted under 21 CFR 10.25 (Initiation of administrative proceedings). A petition for reconsideration must contain a full statement in a well-organized format of the factual and legal grounds upon which the petition relies. The grounds must demonstrate that relevant information and views contained in the administrative record were not previously or not adequately considered by the Commissioner. The respondent must submit a petition no later than 30 days after the decision involved. However, the Commissioner may, for good cause, permit a petition to be filed after 30 days. An interested person who wishes to rely on information or views not included in the administrative record shall submit them with a new petition to modify the decision. FDA uses the information provided in the request to determine whether to grant [[Page 30737]] the petition for reconsideration. Respondents to this collection of information are individuals of households, State or local governments, not-for-profit institutions, and businesses or other for-profit institutions who are requesting from the Commissioner of FDA a reconsideration of a matter. Section 10.35 (21 CFR 10.35), issued under section 701(a) of the FD&C Act, sets forth the format and procedures by which an interested person may request, in accordance with Sec. 10.20, the Commissioner to stay the effective date of any administrative action. Such a petition must do the following: (1) Identify the decision involved; (2) state the action requested, including the length of time for which a stay is requested; and (3) include a statement of the factual and legal grounds on which the interested person relies in seeking the stay. FDA uses the information provided in the request to determine whether to grant the petition for stay of action. Respondents to this information collection are interested persons who choose to file a petition for an administrative stay of action. Section 10.85 (21 CFR 10.85), issued under section 701(a) of the FD&C Act, sets forth the format and procedures by which an interested person may request, in accordance with Sec. 10.20, an advisory opinion from the Commissioner on a matter of general applicability. When making a request, the petitioner must provide a concise statement of the issues and questions on which an opinion is requested, and a full statement of the facts and legal points relevant to the request. Respondents to this collection of information are interested persons seeking an advisory opinion from the Commissioner. FDA has developed a method for electronic submission of citizen petitions. The Agency still allows for non-electronic submissions; however, electronic submissions of a citizen petition to a specific electronic docket presents a simpler and more straightforward approach. FDA has created a single docket on https://www.regulations.gov, the U.S. Government's consolidated docket website for Federal Agencies, for the initial electronic submission of all citizen petitions. The advantage to this is that it ensures efficiency and ease in communication, quicker interaction between citizen petitioners and FDA, and easier access to FDA to seek input through the citizen petition process. The regulations in 21 CFR 12.22, issued under section 701(e)(2) of the FD&C Act, set forth the instructions for filing objections and requests for a hearing on a regulation or order under Sec. 12.20(d) (21 CFR 12.20(d)). Objections and requests must be submitted within the time specified in Sec. 12.20(e). Each objection, for which a hearing has been requested, must be separately numbered and specify the provision of the regulation or the proposed order. In addition, each objection must include a detailed description and analysis of the factual information and any other document, with some exceptions, supporting the objection. Failure to include this information constitutes a waiver of the right to a hearing on that objection. FDA uses the description and analysis to determine whether a hearing request is justified. The description and analysis may be used only for the purpose of determining whether a hearing has been justified under 21 CFR 12.24 and does not limit the evidence that may be presented if a hearing is granted. Respondents to this information collection are those parties that may be adversely affected by an order or regulation. Section 12.45 (21 CFR 12.45), issued under section 701 of the FD&C Act, sets forth the format and procedures for any interested person to file a petition to participate in a formal evidentiary hearing, either personally or through a representative. Section 12.45 requires that any person filing a notice of participation state their specific interest in the proceedings, including the specific issues of fact about which the person desires to be heard. This section also requires that the notice include a statement that the person will present testimony at the hearing and will comply with specific requirements in 21 CFR 12.85, or, in the case of a hearing before a Public Board of Inquiry, concerning disclosure of data and information by participants (21 CFR 13.25). In accordance with Sec. 12.45(e) the presiding officer may omit a participant's appearance. The presiding officer and other participants will use the collected information in a hearing to identify specific interests to be presented. This preliminary information serves to expedite the prehearing conference and commits participation. The respondents are individuals or households, State or local governments, not-for-profit institutions and businesses, or other for- profit groups and institutions. In the Federal Register of February 22, 2018 (83 FR 7742), FDA published a 60-day notice requesting public comment on the proposed collection of information. Although one comment was received, it was not responsive to the four collection of information topics solicited and therefore will not be discussed in this document. 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 ---------------------------------------------------------------------------------------------------------------- 10.30--Citizen petition......... 220 1 220 24 5,280 10.33--Administrative 6 1 6 10 60 reconsideration of action...... 10.35--Administrative stay of 6 1 5 10 50 action......................... 10.85--Requests for Advisory 4 1 4 16 64 opinions....................... 12.22--Filing objections and 5 1 5 20 100 requests for a hearing on a regulation or order............ 12.45--Notice of participation.. 5 1 5 3 15 Total....................... .............. .............. .............. .............. 5,569 ---------------------------------------------------------------------------------------------------------------- \1.\There are no capital costs or operating and maintenance costs associated with this collection of information. The burden estimates for this collection of information are based on Agency records and experience over the past 3 years. The increase in burden hours is due to an increase in the number of respondents under several provisions. [[Page 30738]] Dated: June 26, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-14058 Filed 6-28-18; 8:45 am] BILLING CODE 4164-01-P
![30736 Federal Register / Vol. 83, No. 126 / Friday, June 29, 2018 / Notices
ANNUAL BURDEN ESTIMATES
Number of Average
Total/annual Annual
responses burden
Instrument number of burden
per hours per
respondents hours
respondent response
Needs Assessment Survey ............................................................................. 216 2 0.25 108
Estimated Total Annual Burden DEPARTMENT OF HEALTH AND Administrative Practices and
Hours: 108. HUMAN SERVICES Procedures; Formal Evidentiary Public
Hearing
DATES: Comments due within 60 days of
Food and Drug Administration
publication. In compliance with the OMB Control Number 0910–0191—
requirements of Section 3506(c)(2)(A) of Extension
[Docket No. FDA–2014–N–2029]
the Paperwork Reduction Act of 1995, The Administrative Procedures Act (5
the Administration for Children and Agency Information Collection U.S.C. 553(e)) provides that every
Families is soliciting public comment Activities; Submission for Office of Agency shall give an interested person
on the specific aspects of the Management and Budget Review; the right to petition for issuance,
information collection described above. Comment Request; Administrative amendment, or repeal of a rule. Section
Practices and Procedures; Formal 10.30 (21 CFR 10.30) sets forth the
ADDRESSES: Copies of the proposed
format and procedures by which an
collection of information can be Evidentiary Public Hearing
interested person may submit to FDA, in
obtained and comments may be accordance with § 10.20 (21 CFR 10.20),
forwarded by writing to the AGENCY: Food and Drug Administration,
HHS. a citizen petition requesting the
Administration for Children and Commissioner of Food and Drugs (the
Families, Office of Planning, Research, ACTION: Notice. Commissioner) to issue, amend, or
and Evaluation, 330 C Street SW, revoke a regulation or order, or to take
Washington, DC 20201, Attn: OPRE SUMMARY: The Food and Drug or refrain from taking any other form of
Reports Clearance Officer. Email Administration (FDA) is announcing administrative action.
address: OPREinfocollection@ that a proposed collection of The Commissioner may grant or deny
acf.hhs.gov. All requests should be information has been submitted to the such a petition, in whole or in part, and
identified by the title of the information Office of Management and Budget may grant such other relief or take other
collection. (OMB) for review and clearance under action as the petition warrants.
the Paperwork Reduction Act of 1995. Respondents are individuals or
SUPPLEMENTARY INFORMATION: The
households, State or local governments,
Department specifically requests DATES: Fax written comments on the and not-for-profit institutions or groups.
comments on (a) whether the proposed collection of information by July 30, Section 10.33 (21 CFR 10.33), issued
collection of information is necessary 2018. under section 701(a) of the Federal,
for the proper performance of the Food, Drug, and Cosmetic Act (FD&C
functions of the agency, including ADDRESSES: To ensure that comments on Act) (21 U.S.C. 371(a)), sets forth the
whether the information shall have the information collection are received, format and procedures by which an
practical utility; (b) the accuracy of the OMB recommends that written interested person may request
agency’s estimate of the burden of the comments be faxed to the Office of reconsideration of part or all of a
proposed collection of information; (c) Information and Regulatory Affairs, decision of the Commissioner on a
the quality, utility, and clarity of the OMB, Attn: FDA Desk Officer, Fax: 202– petition submitted under 21 CFR 10.25
information to be collected; and (d) 395–7285, or emailed to oira_ (Initiation of administrative
ways to minimize the burden of the submission@omb.eop.gov. All proceedings). A petition for
collection of information on comments should be identified with the reconsideration must contain a full
respondents, including through the use OMB control number 0910–0191. Also statement in a well-organized format of
of automated collection techniques or include the FDA docket number found the factual and legal grounds upon
other forms of information technology. in brackets in the heading of this which the petition relies. The grounds
Consideration will be given to document. must demonstrate that relevant
comments and suggestions submitted information and views contained in the
FOR FURTHER INFORMATION CONTACT: administrative record were not
within 60 days of this publication.
Amber Sanford, Office of Operations, previously or not adequately considered
Authority: Sec. 413, Pub. L. 115–31. Food and Drug Administration, Three by the Commissioner. The respondent
Mary B. Jones, White Flint North, 10A–12M, 11601 must submit a petition no later than 30
Landsdown St., North Bethesda, MD days after the decision involved.
ACF/OPRE Certifying Officer.
20852, 301–796–8867, PRAStaff@ However, the Commissioner may, for
[FR Doc. 2018–14037 Filed 6–28–18; 8:45 am]
good cause, permit a petition to be filed
sradovich on DSK3GMQ082PROD with NOTICES
fda.hhs.gov.
BILLING CODE 4184–09–P after 30 days. An interested person who
SUPPLEMENTARY INFORMATION: In wishes to rely on information or views
compliance with 44 U.S.C. 3507, FDA not included in the administrative
has submitted the following proposed record shall submit them with a new
collection of information to OMB for petition to modify the decision. FDA
review and clearance. uses the information provided in the
request to determine whether to grant
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![30738 Federal Register / Vol. 83, No. 126 / Friday, June 29, 2018 / Notices
Dated: June 26, 2018. www.regulations.gov will be posted to second copy, which will have the
Leslie Kux, the docket unchanged. Because your claimed confidential information
Associate Commissioner for Policy. comment will be made public, you are redacted/blacked out, will be available
[FR Doc. 2018–14058 Filed 6–28–18; 8:45 am] solely responsible for ensuring that your for public viewing and posted on
BILLING CODE 4164–01–P comment does not include any https://www.regulations.gov. Submit
confidential information that you or a both copies to the Dockets Management
third party may not wish to be posted, Staff. If you do not wish your name and
DEPARTMENT OF HEALTH AND such as medical information, your or contact information to be made publicly
HUMAN SERVICES anyone else’s Social Security number, or available, you can provide this
confidential business information, such information on the cover sheet and not
Food and Drug Administration as a manufacturing process. Please note in the body of your comments and you
[Docket No. FDA–2009–D–0268] that if you include your name, contact must identify this information as
information, or other information that ‘‘confidential.’’ Any information marked
Agency Information Collection identifies you in the body of your as ‘‘confidential’’ will not be disclosed
Activities; Proposed Collection; comments, that information will be except in accordance with 21 CFR 10.20
Comment Request; Labeling of Certain posted on https://www.regulations.gov. and other applicable disclosure law. For
Beers Subject to the Labeling • If you want to submit a comment more information about FDA’s posting
Jurisdiction of the Food and Drug with confidential information that you of comments to public dockets, see 80
Administration do not wish to be made available to the FR 56469, September 18, 2015, or access
public, submit the comment as a the information at: https://www.gpo.gov/
AGENCY: Food and Drug Administration, written/paper submission and in the fdsys/pkg/FR-2015-09-18/pdf/2015-
HHS. manner detailed (see ‘‘Written/Paper 23389.pdf.
ACTION: Notice. Submissions’’ and ‘‘Instructions’’). Docket: For access to the docket to
SUMMARY: The Food and Drug Written/Paper Submissions read background documents or the
Administration (FDA or Agency) is electronic and written/paper comments
Submit written/paper submissions as received, go to https://
announcing an opportunity for public follows: www.regulations.gov and insert the
comment on the proposed collection of • Mail/Hand Delivery/Courier (for docket number, found in brackets in the
certain information by the Agency. written/paper submissions): Dockets
Under the Paperwork Reduction Act of heading of this document, into the
Management Staff (HFA–305), Food and ‘‘Search’’ box and follow the prompts
1995 (PRA), Federal Agencies are Drug Administration, 5630 Fishers
required to publish notice in the and/or go to the Dockets Management
Lane, Rm. 1061, Rockville, MD 20852. Staff, 5630 Fishers Lane, Rm. 1061,
Federal Register concerning each • For written/paper comments
proposed collection of information, Rockville, MD 20852.
submitted to the Dockets Management
including each proposed extension of an FOR FURTHER INFORMATION CONTACT:
Staff, FDA will post your comment, as
existing collection of information, and well as any attachments, except for Domini Bean, Office of Operations,
to allow 60 days for public comment in information submitted, marked and Food and Drug Administration, Three
response to the notice. This notice identified, as confidential, if submitted White Flint North, 10A–12M, 11601
solicits comments on the information as detailed in ‘‘Instructions.’’ Landsdown St., North Bethesda, MD
collection provisions of the Instructions: All submissions received 20852, 301–796–5733, PRAStaff@
recommended labeling of certain beers must include the Docket No. FDA– fda.hhs.gov.
subject to our labeling jurisdiction. 2009–D–0268 for ‘‘Agency Information SUPPLEMENTARY INFORMATION: Under the
DATES: Submit either electronic or Collection Activities; Proposed PRA (44 U.S.C. 3501–3520), Federal
written comments on the collection of Collection; Comment Request; Labeling Agencies must obtain approval from the
information by August 28, 2018. of Certain Beers Subject to the Labeling Office of Management and Budget
ADDRESSES: You may submit comments Jurisdiction of the Food and Drug (OMB) for each collection of
as follows. Please note that late, Administration.’’ Received comments, information they conduct or sponsor.
untimely filed comments will not be those filed in a timely manner (see ‘‘Collection of information’’ is defined
considered. Electronic comments must ADDRESSES), will be placed in the docket in 44 U.S.C. 3502(3) and 5 CFR
be submitted on or before August 28, and, except for those submitted as 1320.3(c) and includes Agency requests
2018. The https://www.regulations.gov ‘‘Confidential Submissions,’’ publicly or requirements that members of the
electronic filing system will accept viewable at https://www.regulations.gov public submit reports, keep records, or
comments until midnight Eastern Time or at the Dockets Management Staff provide information to a third party.
at the end of August 28, 2018. between 9 a.m. and 4 p.m., Monday Section 3506(c)(2)(A) of the PRA (44
Comments received by mail/hand through Friday. U.S.C. 3506(c)(2)(A)) requires Federal
delivery/courier (for written/paper • Confidential Submissions—To Agencies to provide a 60-day notice in
submissions) will be considered timely submit a comment with confidential the Federal Register concerning each
if they are postmarked or the delivery information that you do not wish to be proposed collection of information,
service acceptance receipt is on or made publicly available, submit your including each proposed extension of an
before that date. comments only as a written/paper existing collection of information,
submission. You should submit two before submitting the collection to OMB
Electronic Submissions copies total. One copy will include the
sradovich on DSK3GMQ082PROD with NOTICES
for approval. To comply with this
Submit electronic comments in the information you claim to be confidential requirement, FDA is publishing notice
following way: with a heading or cover note that states of the proposed collection of
• Federal eRulemaking Portal: ‘‘THIS DOCUMENT CONTAINS information set forth in this document.
https://www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ The With respect to the following
instructions for submitting comments. Agency will review this copy, including collection of information, FDA invites
Comments submitted electronically, the claimed confidential information, in comments on these topics: (1) Whether
including attachments, to https:// its consideration of comments. The the proposed collection of information
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Document Created: 2018-06-29 01:13:03
Document Modified: 2018-06-29 01:13:03
| 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 July 30, 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 30736 |
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