81 FR 58942 - Agency Information Collection Activities; Proposed Collection; Comment Request; User Account Management Function for the Import Trade Auxiliary Communication System
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 166 (August 26, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 166 (August 26, 2016)
| Page Range | 58942-58944 | |
| FR Document | 2016-20472 |
[Federal Register Volume 81, Number 166 (Friday, August 26, 2016)] [Notices] [Pages 58942-58944] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-20472] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-2496] Agency Information Collection Activities; Proposed Collection; Comment Request; User Account Management Function for the Import Trade Auxiliary Communication System 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, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the collection of information required to implement user account management function in FDA's Import Trade Auxiliary Communication System (ITACS). Secure user accounts will allow import trade users to receive Notices of FDA Action and requests for specific information via email or via download within ITACS. DATES: Submit either electronic or written comments on the collection of information by October 25, 2016. 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-2016-N-2496 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; User Account Management Function for the Import Trade Auxiliary Communication System.'' 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 [[Page 58943]] 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, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, 20852, [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 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. Account Management Function for the Import Trade Auxiliary Communication System--OMB Control Number 0910-NEW ITACS currently provides the import trade community with four functions: The ability to check the status of FDA-regulated entries and lines, the ability to submit entry documentation electronically, the ability to electronically submit the location of goods for those lines targeted for FDA physical examination, and the ability to check estimated laboratory analysis completion dates. No user login accounts are currently necessary to access these functions; all that is necessary is a valid customs entry number that has been successfully transmitted to FDA. FDA has developed ITACS user account management functionality. Implementation of this functionality would allow members of the import trade community to create and manage secure user accounts in ITACS, which would enable FDA to distribute Notices of FDA Action to users electronically via email (rather than regular mail), enable users to download Notices of FDA Action from within ITACS, and allow users to view in ITACS the details of specific information requests which are currently delivered via hard copy Notices of FDA Action. ITACS user account management functionality would also allow for potential future ITACS enhancements, requested by the import trade community, that require user authentication. To create a secure user account for ITACS via the user account management function, a person would have to enter basic information such as the person's name, their employer's name, a contact email address, an account password, etc., into ITACS via the user account management function interface. FDA estimates the burden of this collection of information 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 ---------------------------------------------------------------------------------------------------------------- Creation of ITACS account..... 5,000 1 5,000 0.5 (30 minutes) 2,500 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. [[Page 58944]] Dated: August 22, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-20472 Filed 8-25-16; 8:45 am] BILLING CODE 4164-01-P
![58942 Federal Register / Vol. 81, No. 166 / Friday, August 26, 2016 / Notices
(74 FR 47804). After consideration of collection is approved under OMB ADDRESSES: You may submit comments
comments received in response to the control number 0910–0572. as follows:
draft guidance, the guidance was 4. This guidance also references the
Electronic Submissions
restructured to describe general guidance for industry entitled
approaches to microbiology data ‘‘Updating Labeling for Susceptibility Submit electronic comments in the
collection in the body of the guidance Test Information in Systemic following way:
and to provide more specific Antibacterial Drug Products and • Federal eRulemaking Portal: http://
recommendations in appendixes (e.g., Antimicrobial Susceptibility Testing www.regulations.gov. Follow the
the format for microbiology data Devices’’ for updating labeling instructions for submitting comments.
presentation and an example for information. The information collection Comments submitted electronically,
sections of labeling that pertain to in this guidance has been approved including attachments, to http://
microbiology). under OMB control number 0910–0638. www.regulations.gov will be posted to
This guidance is being issued the docket unchanged. Because your
III. Electronic Access comment will be made public, you are
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115). Persons with access to the Internet solely responsible for ensuring that your
The guidance represents the current may obtain the guidance at either http:// comment does not include any
thinking of FDA on the development, www.fda.gov/Drugs/Guidance confidential information that you or a
analysis, and presentation of ComplianceRegulatoryInformation/ third party may not wish to be posted,
microbiology data for systemic Guidances/default.htm or http:// such as medical information, your or
antibacterial drugs. It does not establish www.regulations.gov. anyone else’s Social Security number, or
any rights for any person and is not confidential business information, such
Dated: August 22, 2016.
binding on FDA or the public. You can as a manufacturing process. Please note
Leslie Kux,
use an alternative approach if it satisfies that if you include your name, contact
Associate Commissioner for Policy. information, or other information that
the requirements of the applicable [FR Doc. 2016–20473 Filed 8–25–16; 8:45 am]
statutes and regulations. identifies you in the body of your
BILLING CODE 4164–01–P comments, that information will be
II. The Paperwork Reduction Act of posted on http://www.regulations.gov.
1995 • If you want to submit a comment
DEPARTMENT OF HEALTH AND with confidential information that you
This guidance refers to previously HUMAN SERVICES
approved collections of information do not wish to be made available to the
found in FDA regulations. These public, submit the comment as a
Food and Drug Administration written/paper submission and in the
collections of information are subject to
review by the Office of Management and [Docket No. FDA–2016–N–2496] manner detailed (see ‘‘Written/Paper
Budget (OMB) under the Paperwork Submissions’’ and ‘‘Instructions’’).
Agency Information Collection
Reduction Act of 1995 (44 U.S.C. 3501– Written/Paper Submissions
Activities; Proposed Collection;
3520).
Comment Request; User Account Submit written/paper submissions as
1. This guidance provides Management Function for the Import follows:
recommendations on the type of Trade Auxiliary Communication • Mail/Hand delivery/Courier (for
information to include in submissions System written/paper submissions): Division of
of the clinical microbiology section of Dockets Management (HFA–305), Food
investigational new drug applications AGENCY: Food and Drug Administration, and Drug Administration, 5630 Fishers
(INDs) and new drug applications HHS. Lane, Rm. 1061, Rockville, MD 20852.
(NDAs) for systemic antibacterial drugs. ACTION: Notice. • For written/paper comments
The microbiology section of an NDA is submitted to the Division of Dockets
required under 21 CFR 314.50(d)(4) and SUMMARY: The Food and Drug Management, FDA will post your
this information collection is approved Administration (FDA) is announcing an comment, as well as any attachments,
under OMB control number 0910–0001. opportunity for public comment on the except for information submitted,
For INDs, this information is required proposed collection of certain marked and identified, as confidential,
under 21 CFR 312.23(a) and approved information by the Agency. Under the if submitted as detailed in
under OMB control number 0910–0014. Paperwork Reduction Act of 1995 (the ‘‘Instructions.’’
2. This guidance also recommends the PRA), Federal Agencies are required to Instructions: All submissions received
types of data that should be submitted publish notice in the Federal Register must include the Docket No. FDA–
in a labeling supplement to update the concerning each proposed collection of 2016–N–2496 for ‘‘Agency Information
microbiology information in approved information, and to allow 60 days for Collection Activities; Proposed
labeling if an application holder chooses public comment in response to the Collection; Comment Request; User
to update this information without notice. This notice solicits comments on Account Management Function for the
relying on a standard recognized by the collection of information required to Import Trade Auxiliary Communication
FDA. The submission of labeling implement user account management System.’’ Received comments will be
supplements is required under 21 CFR function in FDA’s Import Trade placed in the docket and, except for
314.70(b)(2)(v) and 201.56(a)(2) and this Auxiliary Communication System those submitted as ‘‘Confidential
information collection is approved (ITACS). Secure user accounts will Submissions,’’ publicly viewable at
mstockstill on DSK3G9T082PROD with NOTICES
under OMB control numbers 0910–0001 allow import trade users to receive http://www.regulations.gov or at the
and 0910–0572, respectively. Notices of FDA Action and requests for Division of Dockets Management
3. Appendix D of this guidance specific information via email or via between 9 a.m. and 4 p.m., Monday
describes the content of the download within ITACS. through Friday.
Microbiology subsection of labeling. DATES: Submit either electronic or • Confidential Submissions—To
This labeling is covered under 21 CFR written comments on the collection of submit a comment with confidential
201.57(c)(13)(i) and the information information by October 25, 2016. information that you do not wish to be
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![58944 Federal Register / Vol. 81, No. 166 / Friday, August 26, 2016 / Notices
Dated: August 22, 2016. as to eligibility for, and amount of, the issues described above in the case of
Leslie Kux, compensation. the petitions listed below. Any person
Associate Commissioner for Policy. A petition may be filed with respect choosing to do so should file an original
[FR Doc. 2016–20472 Filed 8–25–16; 8:45 am] to injuries, disabilities, illnesses, and three (3) copies of the information
BILLING CODE 4164–01–P
conditions, and deaths resulting from with the Clerk of the U.S. Court of
vaccines described in the Vaccine Injury Federal Claims at the address listed
Table (the Table) set forth at 42 CFR above (under the heading ‘‘For Further
DEPARTMENT OF HEALTH AND 100.3. This Table lists for each covered Information Contact’’), with a copy to
HUMAN SERVICES childhood vaccine the conditions that HRSA addressed to Director, Division of
may lead to compensation and, for each Injury Compensation Programs,
Health Resources and Services condition, the time period for Healthcare Systems Bureau, 5600
Administration occurrence of the first symptom or Fishers Lane, 08N146B, Rockville,
manifestation of onset or of significant Maryland 20857. The Court’s caption
National Vaccine Injury Compensation aggravation after vaccine (Petitioner’s Name v. Secretary of Health
Program; List of Petitions Received administration. Compensation may also and Human Services) and the docket
AGENCY: Health Resources and Services be awarded for conditions not listed in number assigned to the petition should
Administration, HHS. the Table and for conditions that are be used as the caption for the written
manifested outside the time periods submission. Chapter 35 of title 44,
ACTION: Notice.
specified in the Table, but only if the United States Code, related to
SUMMARY: The Health Resources and petitioner shows that the condition was paperwork reduction, does not apply to
Services Administration (HRSA) is caused by one of the listed vaccines. information required for purposes of
publishing this notice of petitions Section 2112(b)(2) of the PHS Act, 42 carrying out the Program.
received under the National Vaccine U.S.C. 300aa–12(b)(2), requires that
‘‘[w]ithin 30 days after the Secretary Dated: August 18, 2016.
Injury Compensation Program (the James Macrae,
Program), as required by Section receives service of any petition filed
under section 2111 the Secretary shall Acting Administrator.
2112(b)(2) of the Public Health Service
(PHS) Act, as amended. While the publish notice of such petition in the List of Petitions Filed
Secretary of Health and Human Services Federal Register.’’ Set forth below is a
list of petitions received by HRSA on 1. Joel Flores, San Antonio, Texas, Court of
is named as the respondent in all Federal Claims No: 16–0788V.
proceedings brought by the filing of July 1, 2016, through July 31, 2016. This 2. Katie Tambouris, Manchester, New
petitions for compensation under the list provides the name of petitioner, city Hampshire, Court of Federal Claims No:
Program, the United States Court of and state of vaccination (if unknown 16–0790V.
Federal Claims is charged by statute then city and state of person or attorney 3. Cassie Keener, Fort Worth, Texas, Court of
with responsibility for considering and filing claim), and case number. In cases Federal Claims No: 16–0791V.
where the Court has redacted the name 4. Manya Cetlin-Salter, Exeter, New
acting upon the petitions. Hampshire, Court of Federal Claims No:
FOR FURTHER INFORMATION CONTACT: For
of a petitioner and/or the case number,
16–0792V.
information about requirements for the list reflects such redaction. 5. Gabrielle Salomone, Philadelphia,
Section 2112(b)(2) also provides that Pennsylvania, Court of Federal Claims
filing petitions, and the Program in
the special master ‘‘shall afford all No: 16–0795V.
general, contact the Clerk, United States
interested persons an opportunity to 6. Tara Hurley, Pawtucket, Rhode Island,
Court of Federal Claims, 717 Madison
submit relevant, written information’’ Court of Federal Claims No: 16–0797V.
Place NW., Washington, DC 20005, 7. Malka Nussbaum on behalf of S. N.,
relating to the following:
(202) 357–6400. For information on 1. The existence of evidence ‘‘that Queens, New York, Court of Federal
HRSA’s role in the Program, contact the there is not a preponderance of the Claims No: 16–0799V.
Director, National Vaccine Injury evidence that the illness, disability, 8. Donna Deaton, Gibsonville, North
Compensation Program, 5600 Fishers injury, condition, or death described in
Carolina, Court of Federal Claims No:
Lane, Room 08N146B, Rockville, MD 16–0802V.
the petition is due to factors unrelated 9. Fredric C. Thompson, Gray, Maine, Court
20857; (301) 443–6593, or visit our Web to the administration of the vaccine
site at: http://www.hrsa.gov/ of Federal Claims No: 16–0803V.
described in the petition,’’ and 10. Sharlee Funai, Wailuku, Hawaii, Court of
vaccinecompensation/index.html. 2. Any allegation in a petition that the Federal Claims No: 16–0807V.
SUPPLEMENTARY INFORMATION: The petitioner either: 11. Dolores Soltero Arias, Auburn,
Program provides a system of no-fault a. ‘‘[S]ustained, or had significantly Washington, Court of Federal Claims No:
compensation for certain individuals aggravated, any illness, disability, 16–0808V.
who have been injured by specified injury, or condition not set forth in the 12. Luisa Gomes, Dorchester, Massachusetts,
childhood vaccines. Subtitle 2 of Title Vaccine Injury Table but which was Court of Federal Claims No: 16–0809V.
XXI of the PHS Act, 42 U.S.C. 300aa– 13. Linda Saucedo, Indialantic, Florida,
caused by’’ one of the vaccines referred Court of Federal Claims No: 16–0810V.
10 et seq., provides that those seeking to in the Table, or 14. Tasha Loyd on behalf of C. L., Tampa,
compensation are to file a petition with b. ‘‘[S]ustained, or had significantly Florida, Court of Federal Claims No: 16–
the U.S. Court of Federal Claims and to aggravated, any illness, disability, 0811V.
serve a copy of the petition on the injury, or condition set forth in the 15. Rebekah R. Codde on behalf of I. R. H.,
Secretary of Health and Human Vaccine Injury Table the first symptom Sacramento, California, Court of Federal
Services, who is named as the or manifestation of the onset or Claims No: 16–0812V.
mstockstill on DSK3G9T082PROD with NOTICES
respondent in each proceeding. The significant aggravation of which did not 16. Maureen Revaitis and Chris Revaitis on
Secretary has delegated this behalf of J. R. Marlton, New Jersey, Court
occur within the time period set forth in
of Federal Claims No: 16–0813V.
responsibility under the Program to the Table but which was caused by a 17. Mary Butler, San Mateo, California, Court
HRSA. The Court is directed by statute vaccine’’ referred to in the Table. of Federal Claims No: 16–0814V.
to appoint special masters who take In accordance with Section 18. David Palmieri, Galloway, New Jersey,
evidence, conduct hearings as 2112(b)(2), all interested persons may Court of Federal Claims No: 16–0818V.
appropriate, and make initial decisions submit written information relevant to 19. Connor Toes, Phoenix, Arizona, Court of
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Document Created: 2016-08-26 10:41:19
Document Modified: 2016-08-26 10:41:19
| 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 October 25, 2016. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, 20852, [email protected] | |
| FR Citation | 81 FR 58942 |
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